Other substances

CoronaVac

A SARS-CoV-2 inactivated virus candidate vaccine.

Phase of research

Potential treatment - clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

Clinical trials

General information

The candidate vaccine being developed by Sinovac is an inactivated + alum type of candidate vaccine. It is based on the inactivated platform, which is also used for non-COVID-19 candidates, such as SARS. Currently, this COVID-19 candidate vaccine has passed clinical evaluation in two (1, 2) Phase I/II trials and a Phase III trial is ongoing.

Synonyms

PiCoVacc

Supporting references

Link	Tested on	Impact factor	Notes	Publication date	DB entry date
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial Elderly Phase II clinical trial Phase I clinical trial Randomized controlled double-blind trial Mixed substance	Adults aged 60 years and older	24.45	No severe adverse reactions linked to the vaccine were observed. Phase I: seroconversion was observed in 100% and 95.7% of subjects in the 3 μg and the 6 μg group, respectively. Phase II: seroconversion was observed in 90.7%, 98%, and 99% of subjects in the 1.5 μg, the 3 μg and the 6 μg group, respectively. The data support the use of the 3 μg dose in the elderly subjects in phase III trials. Sample size: Phase I (per-protocol analyses): 24 + 12 placebo (3 μg group), 23 + 12 placebo (6 μg group); phase II (per-protocol analyses): 97 (1.5 μg group) + 98 (3 μg group) + 98 (6 μg group) + 47 placebo. Dosage: Phase I: two doses (either 3 μg each or 6 μg each) of inactivated virus in alum solution, 28 days apart; phase II: two doses (either 1.5 μg each, 3 μg each, or 6 μg each) of inactivated virus in alum solution, 28 days apart. Primary endpoints: safety - adverse reactions within 28 days of injection; immunogenicity - seroconversion at day 28 post second dose.	Feb/03/2021	Feb/19/2021
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial Phase II clinical trial Phase I clinical trial Randomized controlled double-blind trial Mixed substance	Healthy adults (18-59 years); SARS-CoV-2 CN02 strain (inactivated)	24.45	The vaccine was well tolerated and induced humoral responses against SARS-CoV-2. The immunogenicity was moderate. An improvement in vaccine manufacturing process resulted in increase of seroconversion rates over 90% in both 3 μg and 6 μg dose groups. This was likely due to higher abundance of intact SARS-CoV-2 spike protein in the improved formulation. The 3 μg dose was suggested for phase III clinical trials. Sample size: "Days 0 and 14" pooled vaccination cohorts: 144 (3 μg group) + 144 (6 μg group) + 84 placebo; "Days 0 and 28" pooled vaccination cohorts: 144 (3 μg group) + 144 (6 μg group) + 83 placebo. Dosage: 3 or 6 μg on days 0 and 14 or 0 and 28. Endpoints: The seroconversion of neutralising antibodies to live SARS-CoV-2 (primary immunogenic endpoint); adverse reactions (primary safety endpoint).	Nov/17/2020	Nov/29/2020
Development of an inactivated vaccine candidate for SARS-CoV-2 Animal model Mixed substance	BALB/c mice; Wistar rats; rhesus macaques	41.85	The candidate vaccine elicited immune responses in mice, rats and non-human primates. It was safe and protected rhesus macaques in viral challenges. Antibody-dependent enhancement was not observed.	Jul/03/2020	Apr/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
Susceptibility of Circulating SARS-CoV-2 Variants to Neutralization Spike protein Mixed substance Cohort study	Sera of vaccinated individuals; SARS-CoV-2 Spike pseudovirus (wt, D614G, B.1.1.7, and B.1.351)	74.70	The neutralization titres of sera of vaccinated individuals against B.1.1.7 and B.1.351 variants of SARS-CoV-2 Spike-pseudotyped virus were lower; moreover, a complete loss of neutralization of B.1.351 variant was observed in the majority of samples.	Apr/06/2021	Apr/24/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT05226429	UNAIR Inactivated COVID-19 Vaccine	Recruiting	Phase 1\|Phase 2	Feb/07/2022	Jul/06/2023
Alternative id - UNAIR-MP-INAKTIF-001 Interventions - Biological: UNAIR Inactivated COVID-19 Vaccine, Biological: CoronaVac Biofarma COVID-19 Vaccine Study type - Interventional Study results - No Results Available Study locations - Dr. Soetomo General Hospital, Surabaya, East Java, Indonesia Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 495 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Solicited clinical (local and systemic), laboratory, and unsolicited adverse events, SARS-CoV-2 neutralization antibodies, SARS-CoV-2 binding antibodies, Th1 and Th2
NCT05225285	Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents	Recruiting	Phase 3	Jan/21/2022	Mar/21/2023
Acronym - Curumim Alternative id - FUES04 Interventions - Biological: Inactivated Coronavac/Butantan vaccine, Biological: BNT162b2 (Pfizer) Study type - Interventional Study results - No Results Available Study locations - Valéria Valim, Vitória, Espírito Santo, Brazil Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 1120 Age - 3 Years to 49 Years (Child, Adult) Outcome measures - Viral neutralization assay, Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S), Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2, Dosage of systemic soluble factors, Antigen-specific stimulation of peripheral blood mononuclear cells in vitro, T lymphocytes, B lymphocytes, intracytoplasmic cytokines, RT-PCR confirmed cases, Adverse events
NCT05230940	Efficacy, Immunogenicity, and Safety of TURKOVAC Vaccine Versus the CoronaVac Vaccine Against COVID-19 in Healthy Adolescent (16-18 Years)	Recruiting	Phase 2	Jan/15/2022	Jul/15/2023
Alternative id - TSB-VAC-COV-TUR-EF2B.06 Interventions - Biological: TURKOVAC, Biological: CoronaVac Study type - Interventional Study results - No Results Available Study locations - Health Sciences University Adana City Training and Research Hospital, Pediatric Health and Diseases, Adana, Turkey; Çukurova University Faculty of Medicine Department of Pediatric Infectious Diseases, Adana, Turkey; T.R. Ministry of Health Ankara City Hospital, Pediatric Infectious Diseases Clinic, Ankara, Turkey; Ankara University Faculty of Medicine Department of Pediatric Infectious Diseases, Ankara, Turkey; Hacettepe University Faculty of Medicine Department of Child Health and Diseases Department of Pediatric Infectious Diseases, Ankara, Turkey; Eskişehir Osmangazi University Faculty of Medicine, Department of Child Health and Diseases, Eskişehir, Turkey; İstanbul University İstanbul Faculty of Medicine, Department of Pediatric Infectious Diseases, Istanbul, Turkey; Marmara University Istanbul Pendik Training and Research Hospital, Pediatric Infectious Diseases Clinic, Istanbul, Turkey; T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Pediatric Infectious Diseases Clinic, Istanbul, Turkey; University of Health Sciences İstanbul Şisli Hamidiye Etfal Training and Research Hospital, Pediatric Infectious Diseases Clinic, Istanbul, Turkey; Ege University Faculty of Medicine, Department of Child Health and Diseases, İzmir, Turkey; T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Clinic of Child Health and Diseases, İzmir, Turkey; University of Health Sciences İzmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital, İzmir, Turkey; Erciyes University Faculty of Medicine Department of Pediatric Infectious Diseases, Kayseri, Turkey Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 644 Age - 16 Years to 18 Years (Child, Adult) Outcome measures - COVID-19 Positivity Rate, Protection Rates of TURKOVAC and CoronaVac Vaccines Against Symptomatic COVID-19, Protection rates of TURKOVAC and CoronaVac Vaccines Against Symptomatic COVID-19, The Protection Rates of TURKOVAC and CoronaVac Vaccines in Preventing Hospitalization and Death Against Severe COVID-19, The Incidence of Adverse Events (AEs), The Incidence of Undesirable Adverse Event, The Incidence of Serious Undesirable Adverse Events, The Seropositivity Rate of SARS-CoV2 Specific Binding Antibody, Evaluation of SARS-CoV2 Neutralizing Antibodies, T-Cell Evaluation, The Incidence of Local and Systemic Signs and Symptoms
NCT05150496	Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults in Turkey	Not yet recruiting	Phase 2	Dec/15/2021	Jan/15/2023
Alternative id - PRO-nCOV-2002 Interventions - Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated, Biological: High-dose COVID-19 Vaccine(Vero Cell),Inactivated Study type - Interventional Study results - No Results Available Study locations - Hacettepe University Faculty of Medicine, Department of Internal Diseases / Infectious Diseases and Clinical Microbiology Unit, Ankara, Turkey; Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases, Ankara, Turkey Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 640 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity index-GMT of neutralizing antibodies, Immunogenicity index-Seropositivity rate of neutralizing antibodies, Immunogenicity index-GMI of neutralizing antibodies, Immunogenicity index-The seropositivity rate of neutralizing antibody, Immunogenicity index-GMT of neutralizing antibody, Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs, Safety index-Occurrence, intensity, duration, and relationship of unsolicited AEs, Safety index-Occurrence and relationship of SAEs, Safety index-Occurrence and relationship of AESI
NCT05087368	Immunogenicity and Safety of Heterologous and Homologous Boosting With ChAdOx1-S and CoronaVac or a Formulation of SCB-2019 (COVID-19)	Not yet recruiting	Phase 2	Dec/01/2021	Apr/01/2022
Acronym - TP-SCB-2019001 Alternative id - TP-SCB-2019-001 Interventions - Biological: ChAdOx1-S COVID-19 Vaccine(Fiocruz/Oxford-AstraZeneca), Biological: CoronaVac (Sinovac Biotech), Biological: Adjuvanted Recombinant SARS-CoV-2 TrimericS-protein Subunit Vaccine (SCB-2019 - Clover) Study type - Interventional Study results - No Results Available Study locations - Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio De Grande Do Sul, Brazil; Hospital Gloria D'or, Rio De Janeiro, Rio De, Brazil; Centro de Estudos e Pesquisa em Moléstias Infecciosas (CEPCLIN), Natal, Rio Grande Do Norte, Brazil Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 520 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity - Stage 1, Immunogenicity - Stage 2, Reactogenicity
NCT05057169	Randomized Trial of COVID-19 Booster Vaccinations (Cobovax Study)	Active, not recruiting	Phase 4	Nov/18/2021	Mar/31/2024
Alternative id - BJC053 Interventions - Biological: BNT162b2, Biological: CoronaVac Study type - Interventional Study results - No Results Available Study locations - The University of Hong Kong, Hong Kong, Hong Kong Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 400 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing antibodies, Geometric mean fold rise of SARS-CoV-2 serum neutralizing antibodies, T-cell responses to vaccination, Reactogenicity, Hospitalizations from any cause
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
NCT05119738	Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment	Recruiting		Oct/27/2021	Jun/01/2022
Alternative id - 210410004 Interventions - Biological: Three doses of BNT162b2 (observational), Biological: Two doses of Coronavac and one dose BNT162b2 (observational) Study type - Observational Study results - No Results Available Study locations - Red de Salud UC Christus, Santiago, Chile Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 122 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine)., Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)
NCT05205096	Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of CoronaVac	Active, not recruiting	Phase 1\|Phase 2	Oct/21/2021	Jun/01/2022
Alternative id - IIT-LKM-2021-NCV03-02 Interventions - Biological: Recombinant novel coronavirus vaccine (CHO cells) Study type - Interventional Study results - No Results Available Study locations - Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 480 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity endpoint, Safety endpoint
NCT03348670	Discovery Stage COVID-19 Antigen Presentation Therapeutic Biologics Mix to Treat COVID-19 Virus Infection	Active, not recruiting	Early Phase 1	Oct/20/2021	Mar/28/2022
Acronym - ApTpBioMix Alternative id - IND158083, FWA00015357, IRB00009424, IORG0007849, NDA216636, BLA761273 Interventions - Biological: CoronaVac® plus TICE® BCG Mix for Intradermal Injection Study type - Interventional Study results - No Results Available Study locations - MIDI Clinical Trial Sites -c/o- Dr. Han Xu - Sponsor / Investigators / Physicians / Laboratories Operation Site, Rockville, Maryland, United States Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Treatment Enrollment - 20 Age - 24 Years to 74 Years (Adult, Older Adult) Outcome measures - Negative testing COVID-19 by standard RT-PCR assay
NCT05077176	Phase 3 Booster Vaccination Against COVID-19	Recruiting	Phase 3	Oct/08/2021	Apr/01/2023
Alternative id - Inaktif_Rapel_Faz 3 Interventions - Biological: CoronaVac, Biological: Turkovac Study type - Interventional Study results - No Results Available Study locations - T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital, Ankara, Turkey Region, Turkey; Çukurova University Faculty of Medicine, Department of Infectious Diseases, Adana, Turkey; T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic, Ankara, Turkey; Dışkapı SUAM Infectious Diseases and Clinical Microbiology, Ankara, Turkey; T.R. Ministry of Health Antalya Training And Research Hospital, Antalya, Turkey; T.R. Ministry of Health Aydın State Hospital, Aydın, Turkey; T.R. Ministry of Health Balıkesir Atatürk City Hospital, Balıkesir, Turkey; T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital, Bolu, Turkey; T.R. Ministry of Health Bursa City Hospital, Bursa, Turkey; Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Bursa, Turkey; T.R. Ministry of Health Denizli Acıpayam State Hospital, Denizli, Turkey; T.R. Ministry of Health Elazığ Fethi Sekin City Hospital, Elazığ, Turkey; Erzincan Binali Yıldırım University Training and Research Hospital Traditional and Complementary Medicine Application Center - GETAT, Erzincan, Turkey; T.R. Ministry of Health Erzurum Regional Training and Research Hospital, Erzurum, Turkey; Eskişehir Osmangazi University Eskişehir Osmangazi University Health, Application and Research Hospital, Eskişehir, Turkey; T.R. Ministry of Health Eskişehir City Hospital, Eskişehir, Turkey; T.R. Ministry of Health Dr. Ersin Arslan Training and Research Hospital, Gaziantep, Turkey; T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases, Istanbul, Turkey; Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey; T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital, Istanbul, Turkey; T.R. Ministry of Health Istanbul Provincial Health Directorate Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Prof. Dr. Feriha Öz Emergency Hospital), Istanbul, Turkey; T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic, Istanbul, Turkey; University of Health Sciences İstanbul Ümraniye Training and Research Hospital, Istanbul, Turkey; T.R. Ministry of Health İzmir Katip Çelebi University Atatürk Training and Research Hospital, Infectious Diseases Clinic, İzmir, Turkey; T.R. Ministry of Health İzmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital, İzmir, Turkey; T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases, İzmir, Turkey; Kahramanmaraş Sütçü İmam University Infections Diseases, Kahramanmaraş, Turkey; Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Kayseri, Turkey; T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department, Kayseri, Turkey; Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Kocaeli, Turkey; T.R. Ministry of Health Kocaeli Health Sciences University Derince Training And Research Hospital, Kocaeli, Turkey; T.R. Ministry of Health Konya City Hospital, Konya, Turkey; Kütahya University of Health Sciences, Infectious Diseases and Clinic, Kütahya, Turkey; Kırıkkale University Faculty of Medicine, Department of Internal Medicine, Kırıkkale, Turkey; Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases, Malatya, Turkey; T.R. Ministry of Health Manisa City Hospital, Manisa, Turkey; T.R. Ministry of Health Mersin City Training and Research Hospital, Mersin, Turkey; T.R. Ministry of Health Tekirdağ Çorlu District State Hospital, Tekirdağ, Turkey; Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology, Trabzon, Turkey; Van Yüzüncü Yıl University Hospital, Faculty of Medicine, Infectious Diseases and Clinical Microbiology, Van, Turkey; Şanlıurfa Harran University Hospital, Şanlıurfa, Turkey Study designs - Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 7400 Age - 18 Years to 59 Years (Adult) Outcome measures - Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19, To Evaluate the SARS-CoV2 anti-spike protein immunoglobulin G, Evaluation of SARS-CoV2 Neutralizing Antibodies, T-Cell Evaluation, Incidence of Adverse Events (AE), Incidence of Serious Adverse Events (SAE)
NCT05124509	Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant	Completed		Oct/06/2021	Jan/03/2022
Alternative id - 210405014E Interventions - Biological: Three doses of SARS-CoV-2 BNT162b2 vaccine (observational), Biological: Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational) Study type - Observational Study results - No Results Available Study locations - Pontificia Universidad Católica de Chile, Santiago, Chile Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 147 Age - 18 Years and older (Adult, Older Adult) Outcome measures - IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine., Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine., Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.
NCT04979949	Booster Vaccination Against COVID-19	Active, not recruiting	Phase 2	Jul/12/2021	Mar/11/2022
Alternative id - Hibrid COV-Rapel TR Interventions - Biological: CoronaVac, Biological: Turkovac Study type - Interventional Study results - No Results Available Study locations - Ankara City Hospital Internal Medicine Clinic, Ankara, Turkey; Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic, Istanbul, Turkey; T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases, Istanbul, Turkey; Ümraniye Training and Research Hospital Infectious Diseases, Istanbul, Turkey Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 222 Age - 18 Years to 60 Years (Adult) Outcome measures - Incidence of adverse reactions, Incidence of Serious Adverse Events (SAE), Neutralizing antibody and anti-spike protein immunoglobulin G
NCT04942405	Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) Versus the CoronaVac Vaccine	Active, not recruiting	Phase 3	Jun/21/2021	May/21/2023
Alternative id - TSB-VAC-COV-TUR-F3.01 Interventions - Biological: TURCOVAC, Biological: CoronaVac Study type - Interventional Study results - No Results Available Study locations - T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic, Ankara, Turkey Region, Turkey; Çukurova University Faculty of Medicine, Department of Infectious Diseases, Adana, Turkey; Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology, Ankara, Turkey; Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Ankara, Turkey; Gazi University Faculty of Medicine, Department of Infectious Diseases, Ankara, Turkey; T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital, Ankara, Turkey; T.R. Ministry of Health Ankara Training and Research Hospital Infectious Diseases Clinic, Ankara, Turkey; Akdeniz University Faculty of Medicine, Department of Infectious Diseases, Antalya, Turkey; Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Bursa, Turkey; Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Diyarbakır, Turkey; Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Gaziantep, Turkey; Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology, Istanbul, Turkey; Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey; Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey; T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital, Istanbul, Turkey; T.R. Ministry of Health Istanbul Provincial Health Directorate Bakirkoy Dr. Sadi Konuk Training and Research Hospital (Yeşilköy Prof.Dr. Murat Dilmener Emergency Hospital), Istanbul, Turkey; T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic, Istanbul, Turkey; T.R. Ministry of Health Istanbul Provincial Health Directorate Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Prof. Dr. Feriha Öz Emergency Hospital), Istanbul, Turkey; T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic, Istanbul, Turkey; University of Health Sciences İstanbul Ümraniye Training and Research Hospital, Istanbul, Turkey; Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases, İzmir, Turkey; T.R. Ministry of Health İzmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital, İzmir, Turkey; T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases, İzmir, Turkey; Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Kayseri, Turkey; T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department, Kayseri, Turkey; Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Kocaeli, Turkey; Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases, Malatya, Turkey; Ondokuz Mayıs University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Samsun, Turkey; Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology, Trabzon, Turkey Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 1290 Age - 18 Years to 55 Years (Adult) Outcome measures - Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19., To evaluate the efficacy of one dose of CoronaVac with one dose of TURKOVAC for Real Time-PCR-confirmed symptomatic COVID-19 disease., To assess the safety of TURKOVAC and CoronaVac vaccines., To assess the immunogenicity of TURKOVAC and CoronaVac vaccines., To determine the seropositivity rate of SARS-CoV2 specific binding antibody at 42, 56, 70, 168 and 224 days after the first dose., To evaluate SARS-CoV2 neutralizing antibodies by neutralization test on the first dose day and at 42, 56, 70, 168 and 224 days after the first dose among the subjects vaccinated with TURKOVAC and the subjects vaccinated with CoronaVac., To evaluate the efficacy and hospitalization and death rates of two doses of TURKOVAC vaccine against severe cases of COVID-19., To determine the incidence of adverse reactions and serious adverse events., To evaluate the SARS-CoV2 protein peptide pool-specific T cells (T cell activation) on the first dose day and at 42, 70, 168 and 224 days after the first dose.
NCT05104385	Hacettepe University COVID-19 Vaccinated's Health Cohort- Students of Health Sciences	Enrolling by invitation		Jun/21/2021	Sep/30/2023
Acronym - HU-CoVaCS Alternative id - TCP-2021-19467 Interventions - Other: Observational, prospective, follow-up of the recipients of CoronaVac (inactivated), Pfizer-Biontech (mRNA) vaccines Study type - Observational Study results - No Results Available Study locations - Hacettepe University, Sıhhiye Campus, Ankara, Turkey Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 1500 Age - 20 Years to 36 Years (Adult) Outcome measures - Vaccine-induced immunity (status and durability) against SARS-CoV-2, General health status (physical, mental, social), COVID-19 infection and related health complications
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
NCT04800133	Covid-19 Vaccination in Adolescents and Children	Recruiting	Phase 2	May/08/2021	Mar/31/2025
Acronym - COVAC Alternative id - COVAC01 Interventions - Biological: Tozinameran, Biological: CoronaVac, Biological: CoronaVac, intradermal Study type - Interventional Study results - No Results Available Study locations - Queen Mary Hospital, Hong Kong, Hong Kong, China Study designs - Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 1000 Age - 3 Years to 100 Years (Child, Adult, Older Adult) Outcome measures - Adverse reactions, Binding antibody response, Neutralizing antibody response, T cell response, Vaccine breakthrough, Adverse events, Binding anti-N antibody response
NCT04884685	Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents	Active, not recruiting	Phase 2	May/03/2021	Jan/03/2022
Alternative id - PRO-nCOV-2001 Interventions - Biological: SARS-CoV-2 Inactivated Vaccine, Biological: Placebo Study type - Interventional Study results - No Results Available Study locations - Zanhuang county Center for Disease Control and Prevention, Shijiazhuang, Hebei, China Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 500 Age - 3 Years to 17 Years (Child) Outcome measures - Safety index-incidence of adverse reactions, Safety index-incidence of serious adverse events
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
NCT04765215	Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.	Active, not recruiting		Mar/31/2021	Mar/31/2022
Alternative id - CHEMOCOVAC Interventions - Biological: CoronoVAC Study type - Observational Study results - No Results Available Study locations - Tekirdağ Namık Kemal ÜNiversitesi, Tekirdağ, Turkey Study designs - Observational Model: Case-Control, Time Perspective: Prospective Enrollment - 291 Age - 18 Years to 90 Years (Adult, Older Adult) Outcome measures - Antibody levels above the defined cut-off
NCT04789356	Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity	Active, not recruiting	Phase 4	Mar/18/2021	Mar/01/2022
Acronym - COVACMANAUS Alternative id - CAAE: 44076721.5.0000.0005 Interventions - Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine Study type - Interventional Study results - No Results Available Study locations - Escola Normal Superior - Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil Study designs - Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Treatment Enrollment - 6233 Age - 18 Years to 49 Years (Adult) Outcome measures - Incidence density of moderate and severe clinical cases of COVID-19, Incidence density of moderate and severe clinical cases of COVID-19 after first dose, Incidence density of moderate and severe clinical cases of COVID-19 after second dose, Incidence density of severe clinical cases of COVID-19 after second dose, Median of clinical progression scores between moderate and severe cases, Incidence density of clinical cases virologically confirmed as COVID-19, Mortality confirmed as COVID-19, Incidence density of hospitalizations for any cause, Mortality from any cause, Adverse events, Humoral and cell-mediated immune response, Detection of antibodies against SARS-CoV-2 in samples
NCT04854408	Evaluation of the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns	Completed		Mar/18/2021	May/09/2021
Alternative id - Coronavacendometrium Interventions - Other: healthcare workers with the coronavac vaccine Study type - Observational Study results - No Results Available Study locations - Pinar Yalcin Bahat, Istanbul, İ̇stanbul, Turkey Study designs - Observational Model: Other, Time Perspective: Prospective Enrollment - 300 Age - 18 Years to 45 Years (Adult) Outcome measures - Possible effects of Coronavac vaccine (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccine) on menstrual cycle
NCT04898946	Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong	Recruiting		Mar/08/2021	Mar/08/2022
Alternative id - Covid-19 Vaccine Antibody Interventions - Biological: CoronaVac Vaccine, Biological: BNT162b2 Vaccine Study type - Observational Study results - No Results Available Study locations - Hong Kong Sanatorium & Hospital, Hong Kong, Hong Kong Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 400 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine
NCT04756830	A Study to Assess the Safety and Immunogenicity of the Coronavac Vaccine Against COVID-19	Active, not recruiting	Phase 4	Feb/19/2021	Jun/01/2023
Alternative id - IDOR_VAC_01 Interventions - Biological: Adsorbed COVID-19 (inactivated) Vaccine Study type - Interventional Study results - No Results Available Study locations - Hospital Gloria D'Or - Hospitais Integrados da Gavea S/A, Rio De Janeiro, Brazil; D'Or Institute for Research and Education, Rio De Janeiro, Brazil Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 1200 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Frequency of local and systemic adverse reactions in the first 7 days after immunization, Seroconversion rates, Frequency of adverse reactions up to 28 days after immunization, Frequency of severe adverse events, Frequency of adverse events of special interest, Cell-mediated immune response, Frequency of detection of antibodies against SARS-CoV-2, Geometric mean titer of neutralizing antibodies
NCT05026879	Adverse Events Report of Inactivated COVID-19 Vaccine	Completed		Feb/14/2021	Mar/14/2021
Alternative id - 24.02.2021-29 Interventions - Biological: Inactivated COVID-19 vaccine (CoronaVac) Study type - Observational Study results - No Results Available Study locations - University of Health Sciences Izmir Bozyaka Training and Research Hospital, Izmir, Karabaglar, Turkey Study designs - Observational Model: Cohort, Time Perspective: Cross-Sectional Enrollment - 4040 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Adverse events detection
NCT04754698	COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS	Active, not recruiting	Phase 4	Feb/09/2021	May/31/2022
Acronym - CoronavRheum Alternative id - 42566621.0.0000.0068 Interventions - Biological: CoronaVac Study type - Interventional Study results - No Results Available Study locations - University of Sao Paulo General Hospital, São Paulo, SP, Brazil Study designs - Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 2067 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity 1, Immunogenicity 2
NCT04582344	Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)	Active, not recruiting	Phase 3	Sep/14/2020	Apr/15/2022
Alternative id - 9026-ASI Interventions - Biological: CoronaVac, Biological: Placebo Study type - Interventional Study results - No Results Available Study locations - T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic, Ankara, Turkey Region, Turkey; T.R. Ministry of Health Ankara Provincial Health Directorate Ankara Training and Research Hospital, Infectious Diseases, Ankara, Turkey Region, Turkey; Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Ankara, Turkey Region, Turkey; Çukurova University Faculty of Medicine, Department of Infectious Diseases, Adana, Turkey; Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology, Ankara, Turkey; T.C Ministry of Health Ankara Provincial Health Directorate Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Ankara, Turkey; Akdeniz University Faculty of Medicine, Department of Infectious Diseases, Antalya, Turkey; Bursa Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Bursa, Turkey; Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Diyarbakır, Turkey; Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Gaziantep, Turkey; Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology, Istanbul, Turkey; Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey; Istanbul Medipol University Faculty of Medicine, Department of Internal Medicine, Istanbul, Turkey; Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey; T.R. Ministry of Health Istanbul Provincial Health Directorate Marmara Univesity Istanbul Pendik Education and Research Hospital, Istanbul, Turkey; T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic, Istanbul, Turkey; T.R. Ministry of Health Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey; University of Health Sciences İstanbul Ümraniye Training and Research Hospital, Istanbul, Turkey; Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases, İzmir, Turkey; Republic Of Turkey Ministry Of Health Izmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital, İzmir, Turkey; T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases, İzmir, Turkey; T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department, Kayseri, Turkey; Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology, Kocaeli, Turkey; Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases, Malatya, Turkey; Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology, Trabzon, Turkey Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 13000 Age - 18 Years to 59 Years (Adult) Outcome measures - Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19, Protection Indexes of One Vaccine Dose For Symptomatic COVID-19, Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death, Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection, Safety indexes of adverse reactions in 28 days, Safety indexes of adverse reactions in 7 days, Safety indexes of serious adverse events in 1 year, Immunogenicity parameters (seroconversion rate, seropositivity rate) in 14 days, Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days, Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 14 days, Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 28 days
NCT04611243	Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19	Recruiting		May/22/2020	Feb/17/2025
Alternative id - 2020.229 Interventions - Biological: third dose vaccination with CoronaVac vaccine, Biological: third dose vaccination with BionTech vaccine, Biological: Vaccination with Coronavac vaccine, Biological: Vaccination with BionTech Vaccine Study type - Observational Study results - No Results Available Study locations - Prince of Wales Hospital, Hong Kong, Hong Kong Study designs - Observational Model: Cohort, Time Perspective: Prospective Enrollment - 700 Age - 18 Years and older (Adult, Older Adult) Outcome measures - spirometry, Lung volume, 6 minute walk distance, quality of life by SF36 questionnaire, serology and T cell response

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