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

AI-suggested 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
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020	in vitro			Mar/26/2020
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
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
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

AI-suggested references

Link	Publication date
mRNA based vaccines provide broad protection against different SARS-CoV-2 variants of concern.	May/12/2021
Safety, mucosal and systemic immunopotency of an aerosolized adenovirus-vectored vaccine against SARS-CoV-2 in rhesus macaques	Jan/02/2022
Anti-SARS-CoV-2 Omicron Antibodies Isolated from a SARS-CoV-2 Delta Semi-Immune Phage Display Library	Feb/10/2022
Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial.	Jul/26/2021
Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial	Jan/27/2022
Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-cont	Dec/23/2021
IgG Antibodies Generation and Side Effects Caused by Ad5-nCoV Vaccine (CanSino Biologics) and BNT162b2 Vaccine (Pfizer/BioNTech) among Mexican Population.	Sep/08/2021
Effect of Heterologous Vaccination Regimen with Ad5-nCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG Antibodies Titers	Mar/03/2022
Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial	Feb/09/2022
Broadly neutralizing antibodies against Omicron-included SARS-CoV-2 variants induced by vaccination	Apr/27/2022
Efficacy and Safety of Heterologous Booster Vaccination after Ad5-nCoV (CanSino Biologics) Vaccine: A Preliminary Descriptive Study	Apr/10/2022
Neutralizing Antibodies against SARS-CoV-2, Anti-Ad5 Antibodies, and Reactogenicity in Response to Ad5-nCoV (CanSino Biologics) Vaccine in Individuals with and without Prior SARS-CoV-2.	Sep/20/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
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 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
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 Locations - 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
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 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.
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 Locations - 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
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 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)
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 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.
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
Alternative id - FH-58 Interventions - Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) Study type - Interventional Study results - No Results Available 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

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