Other substances

ChAdOx1 nCoV-19

A COVID-19 candidate vaccine.

Phase of research

Emergency use authorization

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

Clinical trials

General information

ChAdOx1 nCoV-19 is a candidate vaccine being developed by the University of Oxford and AstraZeneca. It is based on the non-replicating viral vector platform, which is also used for non-COVID-19 candidates, such as influenza, TB, Chikungunya, Zika, MenB, and plague. On Sept. 6, 2020, AstraZeneca put its Phase III clinical trial on hold over safety concerns due to a suspected serious adverse reaction of one participant to the vaccine, but it has since been resumed after the review process. The preliminary findings on safety, reactogenicity, and cellular and humoral immune responses show that ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose. An interim analysis of phase III trials found the vaccine to be efficacious against symptomatic COVID-19 and to have an acceptable safety profile.

On December 30, 2020, AstraZeneca's COVID-19 vaccine was authorized for emergency supply in the UK, with vaccination starting on January 4, 2021. On January 6, 2021, AstraZeneca’s COVID-19 vaccine has been granted emergency use authorization in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunization of adults. On January 29, 2021, the AstraZeneca vaccine was granted conditional marketing authorization by the European Commission following the European Medicines Agency's recommendation, making it available for all EU member states. On February 15, 2021, AstraZeneca’s COVID-19 vaccine was granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals 18 years of age and older, including those over 65.

Synonyms

COV001; AZD1222

Marketed as

COVISHIELD; VAXZEVRIA

Supporting references

Link	Tested on	Impact factor	Notes	Publication date	DB entry date
Fusogenicity and neutralization sensitivity of the SARS-CoV-2 Delta sublineage AY.4.2 Spike protein Spike variant Protein factor In vitro Antibody	HEK 293T cells; U2OS cells; Vero E6 cells; various SARS-CoV-2 live and pseudotyped variants, including Delta and the AY.4.2.	(2021)		Mar/12/2022	Apr/13/2023
SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses ACE2 Antibody Biophysical assay Crystallization DNA In vitro Mixed substance Protein factor RNA Spike protein Spike variant	sera from vaccinated or convalescent individuals; VeroE6/TMPRSS2 cells; SARS-CoV-2 (various strains)	41.58 (2020)	Although the capacity of sera of vaccinated individuals markedly decreased for the omicron strain after a two-dose regimen, a third (booster) vaccination significantly increased omicron neutralization in vitro.	Jan/04/2022	Mar/11/2022
The Omicron variant is highly resistant against antibody-mediated neutralization: Implications for control of the COVID-19 pandemic Spike protein Spike variant Protein factor Viral vector In vitro Antibody	293T cells; A549-ACE2 cells; BHK-21 cells; Vero cells; Huh-7 cells; Calu-3 cells; Caco-2 cells; (VSV) SARS-CoV-2 Spike pseudoviruses (B.1, Alpha, Beta, Gamma, Delta, or Omicron)	41.58 (2020)	The sera of individuals who were primed by this vaccine and boosted by BNT162b2 were more efficient in inhibiting Omicron Spike-mediated cell entry in vitro compared to BNT162b2 prime and boost-vaccinated individuals’ sera. The efficiency was lower compared to the B.1 strain Spike, however.	Dec/23/2021	Feb/18/2022
Effectiveness of COVID-19 vaccines against the B.1.617.2 variant Preprint	adults		2 doses of the AstraZeneca vaccine were 60% effective against symptomatic disease from the B.1.617.2 variant compared to 66% effectiveness against the B.1.1.7 variant.	May/22/2021	May/24/2021
Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial Spike protein Viral vector Randomized controlled single-blind trial Phase III clinical trial Phase II clinical trial Mixed substance	Adult volunteers	60.39	The vaccine efficacy in preventing symptomatic nucleic acid amplification-positive COVID-19 infection was 70.4% for B.1.1.7 strain infection and 81.5% for non-B.1.1.7 infection (mostly BetaCoV/Australia/VIC01/2020 (“Victoria”)) lineage). The sera of vaccinated adults displayed lower neutralization capacity against the B.1.1.7 strain. Sample size: 4244 + 4290 control (primary efficacy cohort), of which there were 311 confirmed SARS-CoV-2 infections. Dosage: Two dose regimen. Primary outcome: Symptomatic COVID-19.	Mar/30/2021	Apr/13/2021
Evidence of escape of SARS-CoV-2 variant B.1.351 from natural and vaccine-induced sera Antibody Biophysical assay DNA In vitro Mixed substance Protein factor RNA Spike protein Spike variant	in vitro biophysical assay; plasma of COVID-19 (Beta strain) convalescent patients or vaccinated adults; Vero cells; SARS-CoV-2 (SARS-CoV-2/human/AUS/VIC01/2020 and SARS-CoV-2/B.1.351)	41.58 (2020)	Neutralization titres against the Beta strain of SARS-CoV-2 were significantly lower compared to the original strain. A majority of samples still neutralized the virus, however.	Feb/23/2021	Mar/11/2022
Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials DNA Mixed substance Phase I clinical trial Phase II clinical trial Phase III clinical trial Randomized controlled double-blind trial Randomized controlled single-blind trial Viral vector	Adult volunteers	60.39	The overall vaccine efficacy >14 days post second dose was 66.7%. The efficacy for a time interval of 22-90 days after a single dose was 76% (the value is not directly comparable with the two-dose regimen due to the trial format). In the subjects who had received 2 doses the efficacy was higher (81.3%) for a longer prime-boost interval (≥12 weeks) than for a shorter one (55.1%; <6 weeks). No hospital admissions were reported in the vaccinated group. Sample size: 8,597 + 8,581 control. Primary outcome: Confirmed symptomatic infection more than 14 days after the second dose.	Feb/19/2021	Mar/07/2021
Reduced neutralization of SARS-CoV-2 B.1.1.7 variant by convalescent and vaccine sera Spike protein RNA Viral vector In vitro Mixed substance Cohort study	Sera of vaccinated subjects; SARS-CoV-2 strain SARS-CoV-2/human/AUS/VIC01/2020 (“Victoria”); SARS-CoV-2 B.1.1.7	38.64	Although a 2.5-fold decrease in neutralization titres against B.1.1.7 strain was observed compared to an early Wuhan-related strain, the neutralization remained robust, and no evidence of vaccine escape was observed.	Feb/18/2021	Apr/03/2021
Reduced neutralization of SARS-CoV-2 B.1.1.7 variant by convalescent and vaccine sera Spike protein Spike variant Crystallization Protein factor In vitro Mechanism Antibody	in vitro biophysical assay; crystallization; sera of COVID-19 convalescent patients or vaccinated adults; Vero cells; SARS-CoV-2 (SARS-CoV-2/human/AUS/VIC01/2020 and SAR-CoV-2/B.1.1.7)	41.58 (2020)	Sera from vaccinated individuals were capable of B.1.1.7 strain neutralization in vitro, despite a modest decrease in neutralization capacity compared to the Victoria strain.	Feb/18/2021	Mar/11/2022
T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial Cohort study Mechanism Mixed substance Phase I clinical trial Phase II clinical trial Spike protein Viral vector	Healthy adults	36.13	After a single dose of vaccine cellular and humoral responses were observed. The response was Th1-biased, with strong interferon gamma and tumor necrosis factor alpha secretion by CD4+ T cells. IgG1 and IgG3 subclasses dominated the antibody response. Various CD8+ T cells were also induced.	Dec/17/2020	Dec/25/2020
A Booster Dose Enhances Immunogenicity of the COVID-19 Vaccine Candidate ChAdOx1 nCoV-19 in Aged Mice Spike protein Viral vector Animal model Mixed substance	C57BL/6Babr mice	N/A (new)	A single intramuscular dose elicited a SARS-CoV-2 Spike-specific immune response in adult mice characterized by specific B- and T-cell responses, with formation of plasma cells, germinal centres, and follicular Th cells. In aged mice, the response was similar, but an impairment in germinal centre formation and production of CD8+ T-cells secreting granzyme B was observed. Boosting reduced this impairment.	Dec/15/2020	Feb/03/2021
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK Phase III clinical trial	Healthy adults	60.39	ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.	Dec/08/2020	Dec/09/2020
Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial Phase II clinical trial Phase III clinical trial Randomized controlled single-blind trial Mixed substance Viral vector	Adults (not infected)	60.39 2019	Systemic adverse effects were less common in adults aged ≥56 years. No serious adverse effect related to the vaccine were observed. Median anti-spike protein (SARS-CoV-2) IgG and neutralising antibody levels 28-days post boost immunization were similar across all age cohorts. >99% of boosted patients had neutralising antibodies by day 14 post boost. T-cell responses peaked at day 14 after a single standard dose. The vaccine is recommended for further efficacy assessment in all age groups and individuals with comorbities. Sample size: Low dose: 50 + 49 control (two doses, 18-55 age group); 30 + 10 control (one dose, 56-69 age group); 30 + 10 control (two doses, 56-69 age group); 50 + 10 control (one dose, 70+ age group); 46 + 10 (two doses, 70+ age group); Standard dose: 49 + 9 control (two doses, 18-55 age group); 30 + 10 control (one dose, 56-69 age group); 30 + 10 control (two doses, 56-69 age group); 50 + 10 control (one dose, 70+ age group); 49 + 10 (two doses, 70+ age group). Dosage: Low dose: 2.2e10 virus particles; standard dose: 3.5–6.5e10 virus particles; cohorts received a single or two doses 28 days apart (see Sample size). Endpoints: Safety and humoral and cellular immunogenicity; efficacy (symptomatic COVID-19 cases).	Nov/18/2020	Nov/19/2020
ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques	rhesus macaques	42.78		Jul/30/2020	May/14/2020
Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial	healthy adults		showed an acceptable safety profile and induced both humoral and cellular immune responses	Jul/20/2020	Jul/30/2020
Evaluation of the immunogenicity of prime-boost vaccination with the replication-deficient viral vectored COVID-19 vaccine candidate ChAdOx1 nCoV-19 Preprint Animal model	mice and pigs			Jun/20/2020	Jun/23/2020
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020	in vitro			Mar/26/2020	Apr/03/2020

Contradictory references

Link	Tested on	Impact factor	Notes	Publication date	DB entry date
Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant Mild severity Mixed substance Moderate severity Phase I clinical trial Phase II clinical trial Randomized controlled double-blind trial Spike protein Viral vector	Adults (aged 18–65)	74.70	The vaccine efficacy against mild to moderate COVID-19 caused by the B.1.31 (“South Africa”) variant was only 10.4%. The vaccine was safe. Sample size for the primary analysis: 884 + 865 placebo. Dosage: Two full doses 21 to 35 days apart. Primary outcomes: Safety and efficacy (against symptomatic COVID-19 ≥14 days post second dose).	Mar/16/2021	Mar/28/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT05135455	VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA	Not yet recruiting		Apr/29/2022	Jun/30/2022
Alternative id - D8111C00005 Study type - Observational Study results - No Results Available Study locations - Research Site, Akita, Japan; Research Site, Chiba, Japan; Research Site, Hyogo, Japan; Research Site, Kumamoto, Japan; Research Site, Mie, Japan; Research Site, Shizuoka, Japan; Research Site, Tokyo, Japan Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 3000 Age - Child, Adult, Older Adult Outcome measures - The incidence of SAEs will be calculated by preferred term (PT) by overall and with/without causal relationships with VAXZEVRIA assessed by investigator(s)., Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case.
NCT05283902	Effectiveness, Immunogenicity and Safety of the Second Booster Dose of the Vaccine Against COVID-19 in the Elderly	Not yet recruiting		Mar/19/2022	Oct/01/2022
Acronym - Plus_Booster Alternative id - FUES05 Interventions - Biological: ChAdOx1 nCoV-19 or Comirnaty or Janssen COVID-19 Vaccine Study type - Observational Study results - No Results Available Study locations - Valéria Valim, Vitória, Espírito Santo, Brazil Study designs - Observational Model: Case-Crossover, Time Perspective: Prospective Enrollment - 490000 Age - 60 Years and older (Adult, Older Adult) Outcome measures - number of hospital admissions, Number of adverse events, number of deaths, number of Covid-19 cases, Viral neutralization assay, Serological assay, Soluble systemic factors, Lymphocyte investigation, Cytokine investigation
NCT05198596	A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 in Adults Aged 18 Years and Above	Not yet recruiting	Phase 3	Mar/01/2022	Dec/01/2022
Alternative id - CT-COV-32 Interventions - Biological: MVC-COV1901, Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Uthumpornphisai Hospital, Sisaket, Thailand Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 250 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity of neutralizing antibody (GMT), Incidence of Adverse Event within 28 days post the second study intervention, Immunogenicity of neutralizing antibody(SCR), Immunogenicity of neutralizing antibody(GMT ratio), Incidence of Adverse Event throughout study conduct
NCT05126992	EU Secondary Data Post-Authorisation Safety Study of AZD1222	Recruiting		Feb/18/2022	Apr/15/2023
Acronym - D8111R00006 Alternative id - D8111R00006 Interventions - Biological: AZD1222 Study type - Observational Study results - No Results Available Study locations - Research Site, Firenze, Italy; Research Site, Utrecht, Netherlands; Research Site, Barcelona, Spain; Research Site, Valencia, Spain; Research Site, Southampton, United Kingdom Study designs - Observational Model: Cohort, Time Perspective: Retrospective Enrollment - 5200000 Age - Child, Adult, Older Adult Outcome measures - Adverse events of special interest
NCT05057897	A Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults	Recruiting	Phase 4	Jan/31/2022	Sep/06/2023
Acronym - VICTORIA Alternative id - D8111C00010 Interventions - Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Research Site, Barranquilla, Colombia; Research Site, Bucaramanga, Colombia; Research Site, Floridablanca, Colombia; Research Site, Cairo, Egypt; Research Site, New Cairo, Egypt; Research Site, Ajmer, India; Research Site, Bangalore, India; Research Site, Bhubaneswar, India; Research Site, Faridabad, India; Research Site, Kolkata, India; Research Site, New Delhi, India; Research Site, Pune, India; Research Site, Surat, India; Research Site, Bangkok, Thailand; Research Site, Bangkok, Thailand; Research Site, Khon Kaen, Thailand; Research Site, Muang, Thailand; Research Site, Diyarbakir, Turkey; Research Site, Kayseri, Turkey; Research Site, Ivano-Frankivsk, Ukraine; Research Site, Kharkiv, Ukraine; Research Site, Kyiv, Ukraine; Research Site, M. Lviv, Ukraine; Research Site, Hanoi, Vietnam Study designs - Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 360 Age - 18 Years to 130 Years (Adult, Older Adult) Outcome measures - SARS-CoV-2 specific titres in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years, Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years, Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants in the comparator cohort as compared with immunocompetent participants, Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants in the comparator cohort as compared with immunocompetent participants, Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants with any immunocompromised condition compared to immunocompetent participants, Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants with any immunocompromised condition compared to immunocompetent participants, Incidence of local and systemic solicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years, Incidence of unsolicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years, Incidence of SAEs, MAAEs and AESIs in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years, Absolute and change from baseline for safety laboratory measures in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
NCT05197153	A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19	Not yet recruiting	Phase 2	Jan/01/2022	Dec/01/2022
Alternative id - CT-COV-24 Interventions - Biological: Half dose of MVC-COV1901, Biological: Full dose of MVC-COV1901, Biological: AZD1222, Biological: Half dose of mRNA-1273 Study type - Interventional Study results - No Results Available Study locations - Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; National Taiwan University Hospital, Taipei, Taiwan; Taipei Municipal Wan Fang Hospital, Taipei, Taiwan; Taipei Veteran General Hospital, Taipei, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 960 Age - 18 Years to 80 Years (Adult, Older Adult) Outcome measures - Incidence of Adverse Events from Day 1 to 28, Primary Immunogenicity-1, Primary Immunogenicity-2, Primary Immunogenicity-3, Primary Immunogenicity-4, Incidence of Adverse Events from Day 1 to 181, Secondary Immunogenicity (Humoral)-1, Secondary Immunogenicity (Humoral)-2, Secondary Immunogenicity (Humoral)-3, Secondary Immunogenicity (Cellular)
NCT05052307	A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil	Recruiting		Nov/03/2021	Oct/01/2023
Alternative id - BNT162b2 in Toledo, Brazil Interventions - Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine, Drug: CoronaVac COVID-19 vaccine, Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine, Drug: Janssen COVID-19 Vaccine Study type - Observational Study results - No Results Available Study locations - Pronto Atendimento Municipal de Toledo, Toledo, Paraná, Brazil Study designs - Observational Model: Case-Control, Time Perspective: Prospective Enrollment - 4500 Age - 12 Years and older (Child, Adult, Older Adult) Outcome measures - Odds of symptomatic SARS-CoV-2 infection, Odds of symptomatic SARS-CoV-2 infection due to Gamma variant, Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern, Duration of COVID-19 symptoms, Incidence of hospitalization due to COVID-19, Incidence of ICU admission, Incidence of mechanical ventilation, Mortality due to COVID-19, Utility score of health-related quality of life at 3 months, Prevalence of long COVID-19 symptoms at 6 months, Incidence of new symptomatic COVID-19 infection, Incidence of any vaccine-related adverse event, Incidence of vaccine-related severe adverse event
NCT05007275	A Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers	Recruiting	Phase 1	Oct/10/2021	Sep/01/2022
Acronym - COVAXAER01 Alternative id - 20HH6296 Interventions - Biological: 1x10^9 vp AZD1222, Biological: 5x10^9 vp AZD1222, Biological: 1x10^10 vp AZD1222 Study type - Interventional Study results - No Results Available Study locations - Imperial College London, London, United Kingdom Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 15 Age - 30 Years to 55 Years (Adult) Outcome measures - To assess the safety, tolerability and reactogenicity profile of the candidate vaccine AZD1222 delivered by aerosol, To assess cellular and humoral immunogenicity of AZD1222
NCT05011526	A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults	Active, not recruiting	Phase 3	Oct/08/2021	Jun/01/2022
Alternative id - CT-COV-31 Interventions - Biological: MVC-COV1901, Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Hospital Fundación Tesai, Ciudad del Este, Paraguay; Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción, San Lorenzo, Paraguay Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 1020 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity of neutralizing antibody (GMT ratio), Incidence of Adverse Event within 28 days post the second study intervention, Immunogenicity of neutralizing antibody (GMT), Immunogenicity of neutralizing antibody(SCR), Immunogenicity of neutralizing antibody(GMT ratio), Incidence of Adverse Event throughout study conduct
NCT05049226	Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine	Enrolling by invitation	Phase 2	Sep/24/2021	Sep/01/2023
Alternative id - TVTN001 Interventions - Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose, Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose, Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half dose Study type - Interventional Study results - No Results Available Study locations - Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok Noi, Bangkok, Thailand; Faculty of Medicine Chulalongkorn University, Pathum Wan, Bangkok, Thailand; Faculty of Medicine Thammasat University, Khlong Luang, Pathum Thani, Thailand; Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital, Mahidol University, Bang Phli, Samut Prakan, Thailand; Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla, Thailand; Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 1320 Age - 20 Years and older (Adult, Older Adult) Outcome measures - GMT Anti-S IgG at baseline and after vaccination, GMFR changed from baseline in anti-S IgG GMT after vaccination, Anti-S IgG Seroresponses changed from baseline after vaccination, GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline and after vaccination, GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus after vaccination, Frequency of solicited reportable local adverse event after vaccination, Frequency of solicited reportable systemic adverse event after vaccination, Frequency of all unsolicited AEs, Frequency of SAEs, NT50 GMT against SARS-Cov-2 by micro neutralization assay at baseline and day 28 and day 90 after vaccination, GMFR changed from baseline in NT50 against SARS-CoV-2 (micro NT Delta/WT NA) at 28 and 90 days after vaccination among those positives by PNT assay, NT50 seroresponses against SARS-CoV-2 using micro NT changed from baseline at 28 and 90 days after vaccination among those positive by PVNT assay
NCT05054621	Immunogenicity of COVID-19 Vaccine on Heterologous Schedule	Recruiting	Phase 2	Sep/15/2021	Aug/31/2022
Alternative id - Heterologous_AZ_Medigen Interventions - Biological: Heterologous prime-boost schedule with AZD1222 and MVC-COV1901, Biological: Homologous prime-boost schedule with two doses of AZD1222 Study type - Interventional Study results - No Results Available Study locations - ChangGungMH, Taoyuan, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 110 Age - 20 Years to 70 Years (Adult, Older Adult) Outcome measures - Immunogenicity: Neutralizing antibody against SARS-CoV-2, Immunogenicity：Anti-SARS-CoV-2 Spike antibody, Adverse events, Immunogenicity: Anti-SARS-CoV-2 Nucleocapsid antibody, Immunogenicity: T cell immunity
NCT04684446	Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19	Recruiting	Phase 1\|Phase 2	Sep/15/2021	Apr/08/2022
Alternative id - D8111C00003 Interventions - Biological: AZD1222, Biological: rAd26-S Study type - Interventional Study results - No Results Available Study locations - Vitebsk Regional Clinical Hospital, Vitebsk, Belarus; Joint-Stock Company "Group of Companies Medsi", Moscow, Russian Federation; OJSC Clinical and Diagnostic Center Euromedservice, Moscow, Russian Federation; Research Site, Moscow, Russian Federation; LLC PiterClinica, Saint-Petersburg, Russian Federation; Federal State Budget Institution "Scientific and Research Institute of Flu n.a. A.A. Smorodintseva" of Ministry of Health of Russian Federation, Saint-Petersburg, Russian Federation; Federal State Budgetary Educational Institution of Higher Education " First Saint Petersburg State Medical University named after Academician I. P. Pavlov" of the Ministry of Healthcare of the Russian Federation, St. Petersburg, Russian Federation Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 100 Age - 18 Years to 130 Years (Adult, Older Adult) Outcome measures - Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 neutralising antibodies 29 days post second vaccination., Incidence of local and systemic solicited AEs for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination)., Incidence of unsolicited AEs, SAEs and AESIs through 29 days post each vaccination (ie, until Day 29 following the first vaccination and Day 57 following the second vaccination)., Incidence of SAEs and AESIs after first vaccination until study end (Day 180)., Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 Spike protein, Antibody seroconversion rate (≥ 4-fold increase from baseline) against RBD antigen., GMT and GMFR of immunogenicity against Spike and RBD antigens (MSD serology assay) at the day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180)., Antibody seroconversion rate (≥ 4-fold increase from baseline) SARS-CoV-2 neutralising antibodies 29 days post first vaccination, GMT and GMFR of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180)., Intracellular cytokine staining, including quantification of Th1/Th2 responses, and flow cytometry for B- and T-cell responses from day of dosing baseline to 29 days post each vaccination and until study end, A binary response, whereby a participant is defined as a COVID-19 case if their illness (virologically confirmed [RT-PCR positive] and symptomatic) occurs
NCT04998240	Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines in Mozambique	Not yet recruiting	Phase 2	Sep/01/2021	Oct/30/2022
Alternative id - IVI-ECOVA-02 Interventions - Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell), Biological: AZD1222 (replication-deficient Ad type 5 vector expressing full-length spike protein) Study type - Interventional Study results - No Results Available Study locations - Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde, Maputo, Mozambique Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single (Outcomes Assessor), Primary Purpose: Prevention Enrollment - 360 Age - 18 Years to 65 Years (Adult, Older Adult) Outcome measures - Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies, Incidence of SAEs and AESI observed at any time point during the entire study period, Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions), Incidence of unsolicited adverse events that are within 28 days after each vaccination, Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination, Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)
NCT04760730	Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of Coronavirus Disease 2019 (COVID-19)	Recruiting	Phase 1\|Phase 2	Jul/13/2021	Jun/30/2022
Alternative id - CV03872091 Interventions - Biological: AZD1222, Biological: rAd26-S Study type - Interventional Study results - No Results Available Study locations - Tawam Hospital, Al Ain, United Arab Emirates Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 100 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Antibody seroconversion rate (≥ 4 fold increase from baseline) against SARS-CoV-2 Spike protein 29 days post second vaccination, Incidence of local and systemic solicited Adverse Events (AEs) for 7 days following each vaccination, Incidence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) through 29 days post each vaccination, Antibody seroconversion rate (≥ 4 fold increase from baseline) against SARS-CoV-2 Spike protein 29 days post first vaccination, Antibody seroconversion rate (≥ 4 fold increase from baseline) against Receptor Binding Domain (RBD) antigen, Сhange from baseline Geometric Mean Titre (GMT) of immunogenicity against Spike and RBD antigens at Day 15, 29, 57, 180., Change from baseline Geometric Mean Fold Rise (GMFR) of immunogenicity against Spike and RBD antigens at Day 15, 29, 57, 180., Antibody seroconversion rate (≥ 4 fold increase from baseline) SARS-CoV-2 neutralising antibodies 29 days post each vaccination (Day 29 and Day 57), Change from baseline GMT of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at Day 15, 29, 57, 180., Change from baseline GMFR of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at Day 15, 29, 57, 180., Change from baseline the number of proliferating CD4 and CD8 cells in response to mitogen stimulation and their ratio in trial subjects., Change from baseline Interferon gamma concentration in response to S Ag simulation
NCT04730895	Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety.	Not yet recruiting	Phase 1\|Phase 2	Jul/01/2021	Dec/01/2023
Acronym - Isotretinoin Alternative id - COVID vaccine Interventions - Drug: Oral 13 cis retinoic acid, Drug: Aerosolized 13 cis retinoic acid, Combination Product: 13 cis retinoic acid doses orally in combination with spike protein based vaccine, Combination Product: Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine, Biological: Biological: spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine Study type - Interventional Study results - No Results Available Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 360 Age - 18 Years to 40 Years (Adult) Outcome measures - Assess the efficacy of the candidate oral and aerosolized isotretinoin for providing complete protection against COVID-19 in adults aged 18 years and older., Assess the safety of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in adults aged 18 years and older., Assess the efficacy of the candidate vaccine spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine for providing complete protection against COVID-19 in adults aged 18 years and older., Assess the efficacy of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 combined with oral and aerosolized isotetinoin in adults aged 18 years and older. for providing complete protection against COVID-19, Assess the safety of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in combination with oral or aersolized 13 cis retinoic acid in adults aged 18 years and older., Assess efficacy of the candidate oral and aerosolized isotretinoin against COVID-19, Assess efficacy of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine against COVID-19, Assess safety of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine combined with oral and aerosolized isotetinoin in vaccinated participants, Assessment the expression of MDAP-5 , RIG-1 , IFN1, TLR3 and IFN1 in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine, Absolute lymphocyte counts (CD4,CD8 and CD25+FOXP3+ Regulatory T cells ) in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine, Assessment the generated IgA antibodies in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine, Thrombin, Assessment the expression of Transe membrane protease ,serine II (TMPRSS2) changes over time in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine, Assessment the expression of Angiotensin-converting enzyme II (ACE2) changes over time in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine, Platelet aggregation in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine, ACE2 autoantibodies IgG and IgM
NCT04914832	Effectiveness of Covid-19 Vaccination in Eswatini Against SARS-CoV-2 Associated Hospitalization and Death	Not yet recruiting	Phase 4	Jun/30/2021	May/31/2022
Alternative id - Eswatini Implementation & VE Interventions - Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Vaccination Center, Mbabane, Swaziland Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 600 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Vaccine effectiveness in HIV-uninfected, To estimate the AZD1222 vaccine effectiveness, To estimate the AZD1222 vaccine effectiveness overall, Vaccine effectiveness in fully vaccinated HIV-uninfected, Vaccine effectiveness in fully vaccinated overall, Vaccine effectiveness according to the vaccine interval between doses, Vaccine effectiveness by genetic variant, Vaccine effectiveness in within populations of special interest, Vaccine effectiveness by time since vaccination
NCT04973449	Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults	Active, not recruiting	Phase 2\|Phase 3	Jun/27/2021	Jun/27/2022
Acronym - AZD2816 Alternative id - D7220C00001 Interventions - Biological: AZD1222, Biological: AZD2816 Study type - Interventional Study results - No Results Available Study locations - Research Site, Brasilia, Brazil; Research Site, Curitiba, Brazil; Research Site, Natal, Brazil; Research Site, Natal, Brazil; Research Site, Porto Alegre, Brazil; Research Site, Salvador, Brazil; Research Site, Lublin, Poland; Research Site, Oświęcim, Poland; Research Site, Puławy, Poland; Research Site, Zamosc, Poland; Research Site, Bloemfontein, South Africa; Research Site, Cape Town, South Africa; Research Site, Johannesburg, South Africa; Research Site, Johannesburg, South Africa; Research Site, Johannesburg, South Africa; Research Site, Somerset West, South Africa; Research Site, Birmingham, United Kingdom; Research Site, Bournemouth, United Kingdom; Research Site, Bristol, United Kingdom; Research Site, Bristol, United Kingdom; Research Site, Edinburgh, United Kingdom; Research Site, Harrow, United Kingdom; Research Site, Hull, United Kingdom; Research Site, London, United Kingdom; Research Site, London, United Kingdom; Research Site, London, United Kingdom; Research Site, London, United Kingdom; Research Site, Manchester, United Kingdom; Research Site, Newcastle-upon-Tyne, United Kingdom; Research Site, Nottingham, United Kingdom; Research Site, Oxford, United Kingdom; Research Site, Plymouth, United Kingdom; Research Site, Portsmouth, United Kingdom; Research Site, Sheffield, United Kingdom; Research Site, Truro, United Kingdom Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 2848 Age - 18 Years to 115 Years (Adult, Older Adult) Outcome measures - The safety and tolerability of 1 dose of AZD2816 in the previously vaccinated cohort with AZD1222, The safety and tolerability of a 2-dose primary vaccination with AZD2816 in the unvaccinated cohort, To determine if the response against B.1.351 elicited by an AZD2816 booster dose in participants previously vaccinated with AZD1222 is non-inferior to the response against Wuhan-Hu-1 strain elicited by 2-dose AZD1222 administered to naïve participants, To determine if the response against the B.1.351 variant elicited by a 2-dose AZD2816 vaccination is non-inferior to the response against the original Wuhan-Hu-1 strain elicited by a 2-dose AZD1222 vaccination in the unvaccinated cohort, To determine if seroresponse against the B.1.351 variant elicited by a 2-dose AZD2816 vaccination is non-inferior to seroresponse against the original WuHan-hu-1 strain elicited by a 2-dose AZD1222 vaccination in the unvaccinated cohort, To determine if the neutralizing antibody GMT response against the B.1.351 variant elicited by a 2-dose AZD2816 vaccination is non-inferior to the response elicited by a 2-dose AZD1222 vaccination in the unvaccinated cohort, To determine if the response against the B.1.351 variant elicited by AZD1222 + AZD2816 vaccination is non-inferior to the response against the Wuhan-Hu-1 strain elicited by AZD1222 in the unvaccinated cohort, To determine if the neutralizing antibody GMT response against the original Wuhan-Hu-1 elicited by a 2-dose AZD2816 vaccination is non-inferior to the response elicited by a 2-dose AZD1222 vaccination, To determine if the response against B.1.351 elicited by an AZD2816 booster dose in participants previously vaccinated with AZD1222 is non-inferior to the response elicited by 2-dose AZD1222 vaccination administered to vaccination naïve participants, To determine if the humoral immune response elicited against the B.1.351 variant by an AZD2816 booster dose is non-inferior to the response elicited by an AZD1222 booster dose in participants previously vaccinated with AZD1222, To determine if the response against the WuHan-hu-1 strain elicited by an AZD2816 booster in participants previously vaccinated with AZD1222 is non-inferior to the response elicited by 2-dose AZD1222 administered to vaccination naïve participants, To determine if the humoral immune response against the original WuHan-hu-1 strain elicited by an AZD1222 booster dose in participants previously vaccinated with AZD1222 is non-inferior to the response elicited by a 2-dose AZD1222 vaccination, To determine if the humoral immune response against the original WuHan-hu-1 strain elicited by an AZD2816 booster dose is non-inferior to the response elicited by an AZD1222 booster dose in participants previously vaccinated with AZD1222
NCT05060861	Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis	Active, not recruiting		Jun/01/2021	Oct/30/2021
Alternative id - Assiut19 Interventions - Other: ChAdOx1 nCoV-19 vaccine Study type - Observational Study results - No Results Available Study locations - Aliae AR Mohamed-Hussein, Assiut, Egypt Study designs - Observational Model: Other, Time Perspective: Other Enrollment - 2000 Age - 18 Years to 80 Years (Adult, Older Adult) Outcome measures - To evaluate the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis
NCT05059106	EFFECTIVENESS, SAFETY AND IMMUNOGENICITY OF THE HALF DOSE OF THE VACCINE ChadOx1 nCoV-19 (AZD1222) for COVID-19	Recruiting	Phase 2\|Phase 3	Jun/01/2021	Oct/30/2022
Alternative id - FUES02 Interventions - Biological: Half dose of ChAdOx1 nCoV-19 (AZD1222), Biological: Standard dose of ChAdOx1 nCoV-19 (AZD1222) Study type - Interventional Study results - No Results Available Study locations - Federal University of Espirito Santo, Vitória, Espirito Santo, Brazil Study designs - Allocation: Non-Randomized, Intervention Model: Sequential Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 29637 Age - 18 Years to 49 Years (Adult) Outcome measures - Incidence of new cases, Number of deaths, number of hospital admissions, number of intensive care unit (ICU) admissions, number of tests (RT-PCR), Viral Neutralization Assay, serological assay, IgM, IgG, systemic soluble factors, Antigen-specific stimulation of peripheral blood mononuclear cells, Lymphocyte investigation, Cytokine investigation
NCT04877743	Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222	Terminated		May/31/2021	Nov/24/2021
Acronym - COVID-19 Alternative id - D8111R00003 Interventions - Other: None (Observational study) Study type - Observational Study results - No Results Available Study locations - Research Site, Amiens, France; Research Site, Argenteuil, France; Research Site, Essen, Germany; Research Site, Hamburg, Germany; Research Site, Logrono, Spain; Research Site, Mataro, Spain; Research Site, Monforte de Lemos, Spain; Research Site, Santiago de Compostela, Spain; Research Site, Goteborg, Sweden; Research Site, Stockholm, Sweden Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 27 Age - 18 Years to 130 Years (Adult, Older Adult) Outcome measures - Number of participants with serious adverse events (SAEs), adverse events of special interest (AESIs) and medically-attended adverse events following immunisation (AEFIs) with AZD1222 for 3 months after vaccination, Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 for up to 18 months after vaccination, Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 categorised by age group, Number of participants with select comorbidities with SAEs, AESIs and medically-attended AEFIs with AZD1222, Prevalence of pregnancies resulting in spontaneous abortions within the AESI medical concept of Pregnancy Outcomes - Maternal, Prevalence of pregnancies resulting in stillbirths within the AESI medical concept of Pregnancy Outcomes - Maternal, Prevalence of pregnancies resulting in preterm births within the AESI medical concept of Pregnancy Outcomes - Maternal, Prevalence of major congenital malformations in the AESI medical concept of Pregnancy Outcomes - Neonates as a measure of infant outcome, Prevalence of small for gestational age in the AESI medical concept of Pregnancy Outcomes - Neonates as a measure of infant outcome
NCT04775069	Antibody Response to COVID-19 Vaccines in Liver Disease Patients	Recruiting	Phase 4	May/21/2021	Mar/31/2022
Alternative id - HHCTC_COVID-19_VACCINE_Ab Interventions - Biological: BNT162b2, Biological: CoronaVac, Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Humanity & Health Medical Group Limited, Hong Kong, Hong Kong Study designs - Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 900 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Antibody response
NCT04907331	Heterologous SARS-CoV-2 Vaccination With ChAdOx-1 and BNT162b2	Recruiting	Phase 2	May/10/2021	Dec/30/2021
Acronym - HeVacc Alternative id - 2021-002171-19 Interventions - Biological: Vaxzevria, Biological: Comirnaty Study type - Interventional Study results - No Results Available Study locations - Medical University of Innsbruck, Innsbruck, Tyrol, Austria Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 3000 Age - 18 Years to 65 Years (Adult, Older Adult) Outcome measures - Neutralizing antibodies, T cells, vaccine failures
NCT04864561	Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine	Recruiting	Phase 3	Apr/26/2021	Mar/16/2023
Acronym - COV-COMPARE Alternative id - VLA2001-301 Interventions - Biological: VLA2001, Biological: AZD1222, Biological: VLA2001 - adolescent part, Biological: Placebo Study type - Interventional Study results - No Results Available Study locations - Barnsley Hospital NHS FT, Barnsley, United Kingdom; University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom; Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom; North Bristol NHS Trust, Bristol, United Kingdom; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom; Cambridge Biomedical Research Centre, Cambridge, United Kingdom; Cheadle Community Hospital, Cheadle, United Kingdom; University Hospitals Coventry & Warwickshire, Coventry, United Kingdom; Western General Hospital, Edinburgh - NHS Lothian, Edinburgh, United Kingdom; Epsom and St. Helier University Hospitals NHS Trust, Epsom, United Kingdom; Queen Elizabeth University Hospital-Glasgow- NHS Greater Glasgow, Glasgow, United Kingdom; Royal Surrey County Hospital NHS Foundation Trust, Guildford, United Kingdom; University Hospitals of Leicester NHS Trust, Leicester, United Kingdom; NHS Foundation Trust Royal Liverpool University Hospital, Liverpool, United Kingdom; Barts Health NHS Trust, London, United Kingdom; Panthera London, London, United Kingdom; Royal Free London NHS Foundation Trust, London, United Kingdom; King's College Hospital, Trust College HOspital NHS Foundation Trust, London, United Kingdom; Chelsea and Westminster Hospital NHS Trust, London, United Kingdom; St George's University Hospitals NHS Foundation Trust, London, United Kingdom; NIHR UCLH Clinical Research Facility, London, United Kingdom; The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital Newcastle, Newcastle, United Kingdom; Northumbria Healthcare NHS Foundation Trust - North Tyneside General Hospital, North Shields, United Kingdom; Lakeside Healthcare Research, Northampton, United Kingdom; Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom; University Hospital Plymouth NHS Trust, Plymouth, United Kingdom; Panthera Biopartners Preston, Preston, United Kingdom; Panthera Biopartners Manchester, Rochdale, United Kingdom; Northern Care Alliance NHS Group, Salford Royal NHS Foundation Trust, Salford, United Kingdom; Southampton University Hospitals NHS Trust, Southampton, United Kingdom; Royal Cornwall Hospitals NHS Trust, Truro, United Kingdom Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 4679 Age - 12 Years and older (Child, Adult, Older Adult) Outcome measures - Immune response measured after completion of a 2-dose immunization schedule, as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies, Immune response measured after completion of a 2-dose immunization schedule, as determined by Seroconversion (definded as 4-fold increase from baseline) of SARS-CoV-2-specific neutralizing antibodies, Frequency and severity of any Adverse Events (AE), Proportion of participants with Seroconversion, Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies., Immune response as determined geometric mean titer (GMT) of IgG antibodies to SARS-CoV-2 S-protein, Assessment of T-cell responses (Th1/Th2 polarization) from PBMCs in a subset of participants after in vitro stimulation with SARS-CoV-2 antibodies using, e.g. ELISpot ir intracellular cytokine staining, Frequency and severity of solcited injection site and systemic reactions, Frequency and severity of any unsolicited Adverse Events (AE), Frequency and severity of any unsolicited vaccine-related Adverse Events (AE), Frequency and severity of any Serious Adverse Event (SAE), Frequency and severity of any Adverse Event Of Special Interest (AESI)
NCT04860739	Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose	Active, not recruiting	Phase 2	Apr/24/2021	Apr/30/2022
Acronym - CombiVacS Alternative id - 5859 Interventions - Drug: COMIRNATY Study type - Interventional Study results - No Results Available Study locations - Hospital Universitario de Cruces, Barakaldo, Vizkaia, Spain; Hospital Vall d´Hebron, Barcelona, Spain; Hospital Clinic de Barcelona, Barcelona, Spain; Hospital Clínico San Carlos, Madrid, Spain; La Paz University Hospital, Madrid, Spain Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 676 Age - 18 Years to 60 Years (Adult) Outcome measures - To assess the humoral immune response against SARS-CoV-2, 14 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing., To assess the humoral immune response against SARS-CoV-2, 28 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (antibodies), To assess the humoral immune response against SARS-CoV-2, 28 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Virus neutralization), To assess the occurrence of symptomatic molecularly confirmed COVID-19 and severity of COVID-19 signs and symptoms after the administration of a dose of COMIRNATY in subjects that received a prior single dose of VAXZEVRIA, To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (solicited adverse events), To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (unsolicited adverse events), To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (serious adverse events), To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Medically-attended adverse events), To assess the humoral immune response against viral variants of SARS-CoV-2, 14 and 28 days after a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA
NCT04816019	A Study of Intranasal ChAdOx1 nCOV-19	Recruiting	Phase 1	Apr/01/2021	Mar/31/2022
Alternative id - COV008 Interventions - Biological: ChAdOx1 nCov-19 Study type - Interventional Study results - No Results Available Study locations - CCVTM, University of Oxford, Churchill Hospital, Oxford, United Kingdom Study designs - Allocation: Randomized, Intervention Model: Sequential Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 54 Age - 18 Years to 55 Years (Adult) Outcome measures - Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms, Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms, Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of adverse events as identified by change in baseline safety laboratory measures, Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs), Assess the mucosal immune response to intranasal administration of one or two doses of ChAdOx1 nCov-19 in healthy adult volunteers
NCT04834869	COVID-19 Vaccines Safety Tracking (CoVaST)	Recruiting		Apr/01/2021	Jan/31/2022
Alternative id - CoVaST Interventions - Biological: BNT162b2, Biological: mRNA-1273, Biological: AZD1222, Biological: CoronaVac, Biological: Sinopharm, Biological: Gam-COVID-Vac, Biological: JNJ-78436735, Biological: CVnCoV, Biological: NVX-CoV2373, Biological: BBV152 Study type - Observational Study results - No Results Available Study locations - American College of Physicians, Philadelphia, Pennsylvania, United States; McMaster University, Hamilton, Ontario, Canada; University of Split, Split, Croatia; Masaryk University, Brno, Czechia; University of Tartu, Tartu, Estonia; Jimma University, Jimma, Ethiopia; Justus-Liebig University Giessen, Giessen, Germany; University of Ghana, Accra, Ghana; Sinaloa's Pediatric Hospital, Culiacán, Mexico; Medical University of Silesia, Katowice, Poland; Nursing School of Coimbra, Coimbra, Portugal; Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences, Irkutsk, Russian Federation; University of Belgrade, Belgrade, Serbia; University of Ljubljana, Ljubljana, Slovenia Study designs - Observational Model: Other, Time Perspective: Prospective Enrollment - 30000 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Local Side Effects, Systemic Side Effects, Unrecognized Side Effects
NCT04794946	Safety and Efficacy of a Non-replicating ChAdOx1 Vector Vaccine AZD1222 (COVISHIELD), for Prevention of COVID-19 in Patients With Liver Cirrhosis	Recruiting	Not Applicable	Mar/19/2021	Mar/19/2022
Alternative id - ILBS-COVID-05 Interventions - Biological: Covishield Study type - Interventional Study results - No Results Available Study locations - Institute of Liver & Biliary Sciences, New Delhi, Delhi, India Study designs - Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Treatment Enrollment - 2200 Age - 18 Years and older (Adult, Older Adult) Outcome measures - To evaluate the efficacy of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis as measured by proportion of patients with presence of antibodies titres compared with the control group., To evaluate the safety/tolerability of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis as measured by comparison of safety profile of AZD1222 (Covishield) in both the groups, To study the profile of immune cells after vaccination., To study the profile of cytokine signatures after vaccination., The proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time., The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using criteria from the CDC., The incidence of SARS-CoV-RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention., Incidence of adverse events, Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest., Incidence of local and systemic solicited adverse events., Determine the rate of new SARS-CoV2 infections, including the mutant strains., To determine the clinical severity of new SARS-CoV2 infections, including that of mutant strains.
NCT04686773	Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention	Active, not recruiting	Phase 2	Mar/05/2021	Mar/07/2022
Alternative id - CV03872092 Interventions - Biological: AZD1222, Biological: rAd26-S Study type - Interventional Study results - No Results Available Study locations - Public legal entity "Baku Health Center", Baku, Azerbaijan Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 100 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination., Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose, Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest, Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination., Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination., Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens, Change from baseline Geometric mean fold rise (GMFR) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens, Antibody seroconversion rate of neutralizing antibodies to SARS-CoV-2 antigen - 29 days after each vaccination, Change from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2, Change from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2
NCT05145348	Prospective Monitoring of Antibody Response Following COVID-19 Vaccination in Patients With Down Syndrome.	Recruiting		Feb/03/2021	Jun/30/2023
Acronym - PRIDE Alternative id - NL76336.041.21 Interventions - Biological: Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) Study type - Observational Study results - No Results Available Study locations - UMC utrecht, Utrecht, Netherlands Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 640 Age - 12 Years and older (Child, Adult, Older Adult) Outcome measures - Antibody based immune response to vaccination against COVID-19 28 days (t=3) after the second vaccination as compared to controls., Longevity of SARS-CoV-2 specific antibodies, SARS-CoV2 specific T cell response, Mucosal SARS-CoV-2 specific antibodies
NCT05133609	COVID-19 VACCINE SAFETY AND EFFECTIVENESS	Recruiting	Phase 1\|Phase 2	Jan/15/2021	Dec/30/2023
Alternative id - FUES03 Interventions - Biological: ChAdOx1 nCoV-19 vaccine (AZD1222) Study type - Interventional Study results - No Results Available Study locations - Federal University of Espirito Santo, Vitoria, Espirito Santo, Brazil Study designs - Allocation: Non-Randomized, Intervention Model: Sequential Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 550 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Viral Neutralization Assay, IgM (Immunoglobulin M), IgG (Immunoglobulin G), IgA (Immunoglobulin G), systemic soluble factors, Antigen-specific stimulation of peripheral blood mononuclear cells, Lymphocyte investigation, Cytokine investigation, Adverse events, severe cases of COVID-19, deaths, hospital admissions, intensive care unit (ICU) admissions
NCT04540393	AZD1222 Vaccine for the Prevention of COVID-19	Withdrawn	Phase 3	Sep/02/2020	May/11/2022
Alternative id - D8111C00001 Interventions - Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Research Site, Moscow, Russian Federation; Research Site, Saint Petersburg, Russian Federation; Research Site, Saint-Petersburg, Russian Federation; Research Site, St. Petersburg, Russian Federation Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Age - 18 Years to 130 Years (Adult, Older Adult) Outcome measures - Incidence of SAEs following the first vaccination and throughout the study duration (Day 180) [Safety and Tolerability]., Incidence of Solicited AEs for 7 following each vaccination [Safety and Tolerability]., SARS-CoV-2 antigen-specific antibody levels, The rate of participants seroconverting from negative to positive SARS-CoV-2 S antigen, The rate of participants seroconverting from negative to positive SARS-CoV-2 N, Quantity of SARS-CoV-2 neutralizing antibodies, Count of peripheral blood mononuclear cells (PBMCs), Quantity of seasonal coronavirus antigens, Quantity of antibodies to the ChAdOx1vector and the persistence of these antibodies over time
NCT04516746	Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults	Active, not recruiting	Phase 3	Aug/28/2020	Feb/14/2023
Alternative id - D8110C00001 Interventions - Biological: AZD1222, Biological: Placebo Study type - Interventional Study results - No Results Available Study locations - Research Site, Phoenix, Arizona, United States; Research Site, Scottsdale, Arizona, United States; Research Site, Little Rock, Arkansas, United States; Research Site, Berkeley, California, United States; Research Site, El Centro, California, United States; Research Site, Los Angeles, California, United States; Research Site, Los Angeles, California, United States; Research Site, San Diego, California, United States; Research Site, San Diego, California, United States; Research Site, San Francisco, California, United States; Research Site, San Francisco, California, United States; Research Site, Torrance, California, United States; Research Site, Denver, Colorado, United States; Research Site, Danbury, Connecticut, United States; Research Site, Coral Gables, Florida, United States; Research Site, Lake Worth, Florida, United States; Research Site, Miami Lakes, Florida, United States; Research Site, Orlando, Florida, United States; Research Site, Honolulu, Hawaii, United States; Research Site, Meridian, Idaho, United States; Research Site, Chicago, Illinois, United States; Research Site, Indianapolis, Indiana, United States; Research Site, Ankeny, Iowa, United States; Research Site, Fairway, Kansas, United States; Research Site, Kansas City, Kansas, United States; Research Site, Wichita, Kansas, United States; Research Site, Wichita, Kansas, United States; Research Site, Lexington, Kentucky, United States; Research Site, Lake Charles, Louisiana, United States; Research Site, Monroe, Louisiana, United States; Research Site, Baltimore, Maryland, United States; Research Site, Baltimore, Maryland, United States; Research Site, Bethesda, Maryland, United States; Research Site, Boston, Massachusetts, United States; Research Site, Boston, Massachusetts, United States; Research Site, Ann Arbor, Michigan, United States; Research Site, Royal Oak, Michigan, United States; Research Site, Minneapolis, Minnesota, United States; Research Site, Gulfport, Mississippi, United States; Research Site, Butte, Montana, United States; Research Site, Portsmouth, New Hampshire, United States; Research Site, Berlin, New Jersey, United States; Research Site, Albuquerque, New Mexico, United States; Research Site, Bronx, New York, United States; Research Site, Brooklyn, New York, United States; Research Site, Mineola, New York, United States; Research Site, New York, New York, United States; Research Site, New York, New York, United States; Research Site, New York, New York, United States; Research Site, Rochester, New York, United States; Research Site, Rochester, New York, United States; Research Site, Valhalla, New York, United States; Research Site, Durham, North Carolina, United States; Research Site, Cincinnati, Ohio, United States; Research Site, Columbus, Ohio, United States; Research Site, Yukon, Oklahoma, United States; Research Site, Portland, Oregon, United States; Research Site, Pittsburgh, Pennsylvania, United States; Research Site, Warwick, Rhode Island, United States; Research Site, Charleston, South Carolina, United States; Research Site, North Charleston, South Carolina, United States; Research Site, Spartanburg, South Carolina, United States; Research Site, Knoxville, Tennessee, United States; Research Site, Nashville, Tennessee, United States; Research Site, Austin, Texas, United States; Research Site, Dallas, Texas, United States; Research Site, Houston, Texas, United States; Research Site, McAllen, Texas, United States; Research Site, San Antonio, Texas, United States; Research Site, San Antonio, Texas, United States; Research Site, Spring, Texas, United States; Research Site, West Jordan, Utah, United States; Research Site, Burlington, Vermont, United States; Research Site, Fort Belvoir, Virginia, United States; Research Site, Richmond, Virginia, United States; Research Site, Seattle, Washington, United States; Research Site, South Charleston, West Virginia, United States; Research Site, Madison, Wisconsin, United States; Research Site, Quillota, Chile; Research Site, Santiago, Chile; Research Site, Santiago, Chile; Research Site, Callao, Peru; Research Site, Cercado De Lima, Peru; Research Site, Lima, Peru Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Treatment Enrollment - 32459 Age - 18 Years to 130 Years (Adult, Older Adult) Outcome measures - The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of COVID-19, The safety and tolerability of 2 IM doses of AZD1222 compared to saline placebo, The reactogenicity of 2 IM doses of AZD1222 compared to saline placebo (Substudy only), The efficacy of 2 IM doses of AZD1222 compared tosaline placebo for the prevention of SARS-CoV-2 infection, The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of symptomatic COVID-19 using CDC criteria, The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of University of Oxford defined symptomatic COVID-19, The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of severe or critical symptomatic COVID-19., The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of COVID-19-related Emergency Department visits, Antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only), Anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only), The efficacy of 2 IM doses of AZD1222 compared to saline placebo in the prevention of COVID-19 in all study participants, regardless of evidence of prior SARS-CoV-2 infection, The efficacy of AZD1222 compared to saline placebo for the prevention of COVID-19 following the first dose
NCT04568031	Study of AZD1222 for the Prevention of COVID-19 in Japan	Completed	Phase 1\|Phase 2	Aug/23/2020	Nov/22/2021
Alternative id - D8111C00002 Interventions - Drug: AZD1222, Drug: 0.9% (w/v) saline Study type - Interventional Study results - No Results Available Study locations - Research Site, Fukuoka-shi, Japan; Research Site, Hachioji-shi, Japan; Research Site, Minato-ku, Japan; Research Site, Sumida-ku, Japan; Research Site, Toshima-ku, Japan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 256 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Proportion of participants who have a post treatment seroresponse to the spike antigens of AZD1222, The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination, The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs), Biochemistry; change from baseline for blood chemistry measures, Haematology; change from baseline for hematology/hemostasis measures, Proportion of participants who have a post treatment, Genometric mean titres and genometric mean fold rise, Proportion of participants who have a post treatment seroresponse to AZD1222 as measured by SARS-CoV-2 nAbs, The incidence of serious adverse events (SAEs) and adverse events of specisl interest (AESIs) collected from Day1 through Day365
NCT04444674	COVID-19 Vaccine (ChAdOx1 nCoV-19) Trial in South African Adults With and Without HIV-infection	Active, not recruiting	Phase 1\|Phase 2	Jun/24/2020	Dec/01/2021
Alternative id - ChAdOx1 nCoV-19_ZA_phI/II v4.1 Interventions - Biological: ChAdOx1 nCoV-19, Biological: Normal saline 0.9% Study type - Interventional Study results - No Results Available Study locations - PHRU Kliptown, Johannesburg, Gauteng, South Africa; Soweto Clinical Trials Centre, Johannesburg, Gauteng, South Africa; Wits RHI Shandukani Research Centre, Johannesburg, Gauteng, South Africa; Setshaba Research Centre (SRC), Soshanguve, Gauteng, South Africa; Chris Hani Baragwanath Academic Hospital - DST/NRF VPD RMPRU, Soweto, Gauteng, South Africa; FAMCRU, Cape Town, Western Cape, South Africa; Groote Schuur hospital, Lung infection and immunity unit, UCT, Cape Town, Western Cape, South Africa Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 2130 Age - 18 Years to 65 Years (Adult, Older Adult) Outcome measures - Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-negative adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety), Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults who receive candidate vaccine ChAdOx1 nCoV-19 compared to placebo recipients (efficacy), Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-positive adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety), Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in people living with HIV (immunogenicity), Assess humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV, Assess humoral Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity), Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity)
NCT04536051	A Study of a Candidate COVID-19 Vaccine (COV003)	Recruiting	Phase 3	Jun/02/2020	Sep/01/2021
Alternative id - COV003 Interventions - Biological: ChAdOx1 nCoV-19 single dose + paracetamol, Biological: MenACWY single dose + paracetamol, Biological: ChAdOx1 nCoV-19 two dose + paracetamol, Biological: MenACWY prime & saline placebo boost + paracetamol Study type - Interventional Study results - No Results Available Study locations - Instituto D'Or de Pesquisa e Ensino - I'Dor, Salvador, Bahia, Brazil; Centro de Pesquisas Clinicas de Natal (CPCLIN), Natal, Rio Grande Do Norte, Brazil; Hospital das Clinicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil; Universidade Federal de Santa Maria (UFSM), Santa Maria, Rio Grande Do Sul, Brazil; Instituto D'Or de Pesquisa e Ensino - I'Dor, Rio de Janeiro, Brazil; CRIE, Universidade Federal de São Paulo, São Paulo, Brazil Study designs - Allocation: Randomized, Intervention Model: Sequential Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 10300 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR, Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination, Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events, Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease, Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: hospitalization for COVID-19 disease confirmed by PCR, Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR, Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease, Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates), Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates), Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus, Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine
NCT04400838	Investigating a Vaccine Against COVID-19	Active, not recruiting	Phase 2\|Phase 3	May/28/2020	Mar/31/2023
Alternative id - COV002 Interventions - Biological: ChAdOx1 nCoV-19 (Abs 260), Biological: MenACWY vaccine, Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost, Biological: Two dose MenACWY vaccine, Biological: ChAdOx1 nCoV-19 (qPCR), Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost, Biological: Two dose MenACWY vaccine min. 4 weeks apart, Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.5mL, Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL Study type - Interventional Study results - No Results Available Study locations - University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, United Kingdom; Castle Hill Hospital, Cottingham, Hull, United Kingdom; St Georges University Hospital NHS Foundation Trust, London, Tooting, United Kingdom; University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom; North Bristol NHS Trust, Bristol, United Kingdom; NIHR Cambridge Clinical Research Facility, Cambridge, United Kingdom; NHS Lothian, Western General Hospital, Edinburgh, United Kingdom; Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital, Glasgow, United Kingdom; Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator, LIverpool, United Kingdom; London North West University Healthcare Trust (LNWUH), Northwick Park Hospital, London, United Kingdom; University College London Hospitals NHS Foundation Trust, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom; The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom; Public Health Wales, Newport, United Kingdom; University of Nottingham Health Service, Cripps Health Centre, University Park, Nottingham, United Kingdom; CCVTM, University of Oxford, Churchill Hospital, Oxford, United Kingdom; John Radcliffe Hospital, Oxford, United Kingdom; Sheffield Teaching Hospitals, Royal Hallamshire Hospital, Sheffield, United Kingdom Study designs - Allocation: Randomized, Intervention Model: Sequential Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 12390 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older., Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults, Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following, Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following, Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination, Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests), Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19, Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification, Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion, Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only), Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity, Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity, Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only), Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests), Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion
NCT04324606	A Study of a Candidate COVID-19 Vaccine (COV001)	Active, not recruiting	Phase 1\|Phase 2	Apr/23/2020	Mar/31/2023
Alternative id - COV001 Interventions - Biological: ChAdOx1 nCoV-19, Biological: MenACWY, Biological: ChAdOx1 nCoV-19 full boost, Biological: ChAdOx1 nCoV-19 half boost, Biological: MenACWY boost, Drug: Paracetamol, Biological: ChAdOx1 nCoV-19 0.5mL boost, Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV), Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT) Study type - Interventional Study results - No Results Available Study locations - University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, United Kingdom; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom; St Georges University Hospital NHS Foundation Trust, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom; CCVTM, University of Oxford, Churchill Hospital, Oxford, United Kingdom; John Radcliffe Hospital, Oxford, United Kingdom Study designs - Allocation: Randomized, Intervention Model: Sequential Assignment, Masking: Single (Participant), Primary Purpose: Treatment Enrollment - 1090 Age - 18 Years to 55 Years (Adult) Outcome measures - Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases, Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs), Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms, Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms, Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs), Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests, Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by hospital admissions, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by ICU admissions, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by COVID-19 related deaths, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19, Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates, Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays, Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19
NCT05110911	Does Repeat Influenza Vaccination Constrain Influenza Immune Responses and Protection	Recruiting		Apr/02/2020	Nov/01/2023
Alternative id - 1R01AI41534 Interventions - Biological: Influenza vaccination: Fluarix Tetra, Vaxigrip Tetra, Fluquadri, Fluad Quad, Afluia Quad, Flucelvax Quad, Biological: SARS-CoV-2 vaccination: Comirnaty or Vaxzevria Study type - Observational Study results - No Results Available Study locations - John Hunter Hospital, New Lambton Heights, New South Wales, Australia; The Children's Hospital at Westmead, Westmead, New South Wales, Australia; Queensland Children's Hospital, Brisbane, Queensland, Australia; Women's and Children's Hospital, Adelaide, South Australia, Australia; The Alfred, Melbourne, Victoria, Australia; Perth Children's Hospital, Nedlands, Western Australia, Australia Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 1500 Age - 18 Years to 60 Years (Adult) Outcome measures - Seropositivity post-vaccination (influenza vaccine), Seropositivity post-season (influenza vaccine), Fold-rise in geometric mean antibody titre (GMT) pre- to post-vaccination, Fold-change in geometric mean antibody titre (GMT) post-vaccination to post-season, Seroconversion fraction post-vaccination, Healthcare workers (HCWs) PCR-positive for influenza at the end of each season, Influenza attack rate at the end of each season, Vaccine efficacy (VE), Duration of illness (influenza), Haemagglutinin (HA) antibody landscapes for vaccine-naïve and highly-vaccinated healthcare workers (HCWs), Haemagglutinin (HA) antibody landscapes for infected versus uninfected healthcare workers (HCWs), Enumeration of cells, B cells, Quantify biological mechanisms that shape the antibody response, Estimate protective titres, Optimal influenza vaccination strategy for healthcare workers (HCWs) under different vaccine availability, Estimated SARS-CoV-2 attack rates among symptomatic and asymptomatic healthcare workers (HCWs), Case-hospitalization risk, Risk factors for asymptomatic, mild and severe SARS-CoV-2 infection, Estimated SARS-CoV-2 antibody titre associated with protection, Estimated SARS-CoV-2 antibody kinetics over time, Identification of key behavioural drivers of transmission, Estimated duration of viral shedding and viral load in SARS-CoV-2 infection over time, Enumeration of SARS-CoV-2-reactive B and T cells and identification of dominant epitopes, Gene expression, Enumeration of SARS-CoV-2-reactive B and T cells induced by each vaccine formulation, Seroconversion of SARS-CoV-2 serum antibody titres induced by each vaccine formulation, Fold changes in innate immune cells and in vaccine specific B and T cells, Comparison of antibody (and B and T cell) responses induced against COVID-19 and influenza vaccines among participants who received COVID-19 versus influenza vaccine first or who were co-administered both vaccines.

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