Other substances

Ad5-nCoV

An adenovirus-vector COVID-19 candidate vaccine.

Phase of research

Potential treatment - clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

Clinical trials

General information

Ad5-nCoV is a COVID-19 candidate vaccine being developed by CanSino Biological Inc. and the Beijing Institute of Biotechnology. It is an Adenovirus Type 5 Vector type of candidate vaccine. It is based on the non-replicating viral vector platform, which is also used for non-COVID-19 candidates, such as Ebola. Currently, this COVID-19 candidate vaccine is being evaluated in Phase I and Phase II clinical trials.

Supporting references

Link	Tested on	Impact factor	Notes	Publication date	DB entry date
A single dose of an adenovirus-vectored vaccine provides protection against SARS-CoV-2 challenge DNA Animal model	BALB/c mice; ferrets	12.12	Adenovirus vaccine for mucosal delivery carrying host-optimized SARS-CoV-2 spike protein gene elicited strong humoral and cellular immune responses in mice and protected them from mouse-adapted SARS-CoV-2 infection in upper and lower respiratory tract. The vaccine also protected ferrets form upper respiratory tract infection by the wild type virus.	Aug/14/2020	Aug/29/2020
Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial	healthy adults		safe, and induced significant immune responses in the majority of recipients after a single immunisation	Jul/20/2020	Aug/05/2020
Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial	healthy adults		The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination.	May/22/2020	May/25/2020
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020	in vitro			Mar/26/2020	Apr/03/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT05169008	A Study to Evaluate the Safety and Immunogenicity of a 2-dose Regimen COVID-19 Vaccine in Children and Adolescents Aged 6-17 Years	Not yet recruiting	Phase 3	Feb/20/2022	Aug/20/2023
Alternative id - CS-CTP-AD5NCOV-PDⅢ Interventions - Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) Study type - Interventional Study results - No Results Available Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 2000 Age - 6 Years to 17 Years (Child) Outcome measures - Incidence of SAE, Immunogenicity of S-RBD IgG antibody, Incidence of Adverse Reactions (ARs), The incidence of AR and AE, Immunogenicity of neutralizing antibodies, Baseline level of pre-existing anti Ad5 antibody
NCT05204589	Heterologous Boost Immunization With an Aerosolised Ad5-nCoV After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine	Recruiting	Phase 3	Jan/22/2022	Sep/01/2022
Alternative id - JSVCT137 Interventions - Biological: Aerosolized Ad5-nCoV, Biological: Inactivated SARS-CoV-2 vaccine Study type - Interventional Study results - No Results Available Study locations - Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, Jiangsu, China Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 10420 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Incidence of adverse reactions within 28 days after the booster dose., GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort., Incidence of adverse reactions within 30 minutes after the booster dose., Incidence of adverse reactions within 14 days after the booster dose., Incidence of adverse events within 28 days after the booster dose., Incidence of serious adverse events (SAE) till the 6 months after the booster dose., Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose., GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose., GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose., Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose., GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline., GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose., The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.
NCT05124561	Study to Evaluate the inHaled Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) On the Protective-Efficacy in Adults (SeiHOPE)	Not yet recruiting	Phase 3	Dec/15/2021	Aug/20/2022
Alternative id - CS-CTP-AD5NCOV-IH-Ⅲ Interventions - Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH), Biological: Placebo Study type - Interventional Study results - No Results Available Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Prevention Enrollment - 13000 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Incidence of COVID-19 cases., Incidence of SAE, Incidence of COVID-19 cases, Incidence of severe COVID-19 cases, Incidence of COVID-19 cases in different age groups, Incidence of Adverse Reactions (ARs), Incidence of Adverse Events (AEs), Immunogenicity of S-RBD IgG antibody (ELISA method), Immunogenicity of neutralizing antibodies
NCT05043259	Heterologous Prime-boost Immunization With an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Priming With an Inactivated SARS-CoV-2 Vaccine	Recruiting	Phase 1\|Phase 2	Sep/13/2021	May/01/2022
Alternative id - JSVCT127 Interventions - Biological: inactive SARS-CoV-2 vaccine (Vero cell), Biological: Low dose aerosolized Ad5-nCoV, Biological: High dose aerosolized Ad5-nCoV Study type - Interventional Study results - No Results Available Study locations - Donghai County Center for Diseases Control and Prevention, Lianyungang, Jiangsu, China Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 420 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Incidence of adverse reactions within 14 days after the booster dose., GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose., Incidence of adverse events within 0-28 days after the booster dose., Incidence of serious adverse events (SAE) till the 12 months after the booster dose., GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose., Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster vaccination., GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose., GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD on day 7, day 14, day 28 after the booster dose., GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD at month 3, 6, and 12 after the booster dose., The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination.
NCT05005156	Phase IIb Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Adults 18 Years of Age and Older.	Recruiting	Phase 2	Jun/24/2021	Sep/30/2022
Acronym - COVID-19 Alternative id - FH-58 Interventions - Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) Study type - Interventional Study results - No Results Available Study locations - Fundacion Huesped, Caba, Buenos Aires, Argentina; Centro de Estudio Infectologicos (CEI), Capital Federal, Buenos Aires, Argentina; Helios Salud, Capital Federal, Buenos Aires, Argentina; Hospital Fernandez, Capital Federal, Buenos Aires, Argentina Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 876 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Evaluate the incidence of solicited adverse reactions at 7 days after vaccination, Evaluate the incidence of unsolicited adverse events at 28 days after vaccination, Suppression of HIV viral load at 24 and 52 weeks, Evaluate the incidence of serious adverse events (SAE) and medically attended adverse events, Evaluate the antibody response attended adverse, Compare antibody response in both group, Evaluate impact in CD4* cell, Evaluate impact in ratio CD4/CD8, Geometric mean antibody titers, Geometric Mean Increase, Evaluate the seroconversion rate of pseudo-virus neutralizing antibody, Evaluate impact in chemokines
NCT04916886	A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.	Recruiting	Not Applicable	Jun/03/2021	Aug/01/2022
Alternative id - JSVCT118 Interventions - Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml, Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml Study type - Interventional Study results - No Results Available Study locations - Funing Center for Disease Control and Prevention, Yancheng, Jiangsu, China Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Other Enrollment - 2016 Age - 6 Years to 59 Years (Child, Adult) Outcome measures - GMT of anti SARS-CoV-2 specific neutralizing antibody, Seroconversion rate of SARS-CoV-2 neutralizing antibody, GMI of SARS-CoV-2 neutralizing antibody, GMT of SARS-CoV-2 S protein RBD antibody, Seroconversion rate of SARS-CoV-2 S protein RBD antibody, GMI of SARS-CoV-2 S protein RBD antibody, GMT of Ad5 vector neutralizing antibody, GMI of Ad5 vector neutralizing antibody, Stratified analysis on Ad5 vector neutralizing antibody, Incidence of Adverse Reactions/Events (AE/AR), Incidence of Serious Adverse Events (SAE), Incidence of Adverse Events of Special Interest (AESI)
NCT04552366	A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults	Active, not recruiting	Phase 1	Sep/29/2020	Jun/30/2021
Alternative id - AMMS85-2004 Interventions - Biological: Ad5-nCoV Study type - Interventional Study results - No Results Available Study locations - Zhongnan Hospital, Wuhan, Hubei, China Study designs - Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 149 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Incidence of the AE in all groups, Seroconversion rate of the IgG antibody against SARS-CoV-2, Geomean titers of the IgG antibody against SARS-CoV-2, Seroconversion rate of the neutralizing antibody against SARS-CoV-2, Geomean titers of the neutralizing antibody against SARS-CoV-2, Incidence of Serious adverse events (SAE) in all groups, Cellular immune response by ELISpot, Geomean titers of neutralizing antibody response to Ad5-vector, Cellular immune response by ICS, Geomean titers of the IgA antibody against SARS-CoV-2

Ad5-nCoV

General information

Supporting references

Clinical trials

Substances

References

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