Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above
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|ClinicalTrials.gov Identifier: NCT04526990|
Recruitment Status : Active, not recruiting
First Posted : August 26, 2020
Last Update Posted : October 31, 2022
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Biological: Placebo||Phase 3|
This is a global phase III clinical trial to evaluate efficacy,safety, immuogenicity of Ad5-nCoV manufactured by Cansino and Beijing Institute of Biotechnology in health adults aged 18 years old and above.
The study will be double-blind, placebo-controlled trial with participants randomly allocated 1:1 to placebo and experimental vaccine cohorts.
The immunization schedule is one doses intramuscular injections (deltoid).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Global Multicenter, Randomized, Double-blind, Placebo -Controlled, Adaptive Designed Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Ad5-nCoV in Adults 18 Years of Age and Older|
|Actual Study Start Date :||September 15, 2020|
|Actual Primary Completion Date :||August 7, 2021|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Experimental group
20000 participants, Ad5-nCoV , single dose, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Placebo Comparator: Placebo group
20000 participants, placebo, single dose, Intramuscular administration
- Incidence of COVID-19 cases [ Time Frame: day 28 to 12 months post vaccination ]The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease
- Incidence of SAE [ Time Frame: Within 12 months ]Evaluate the incidence of severe adverse events (SAE)
- Incidence of severe COVID-19 cases [ Time Frame: Day 14 to 12 months post vaccination ]Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection
- Incidence of solicited adverse reactions [ Time Frame: Day 0-7 post vaccination ]Incidence of solicited adverse reactions within 7 days after vaccination, in a subset
- Incidence of unsolicited adverse events [ Time Frame: Day 0-28 post vaccination ]Incidence of unsolicited adverse events within 28 days after vaccination in a subset
- Immunogencity of S-RBD IgG antibody (ELISA method) [ Time Frame: Day 28 post vaccination ]The seroconversion rate of S-RBD IgG antibody post vaccination
- Immunogencity of neutralizing antibody [ Time Frame: Day 28 post vaccination ]The seroconversion rate of neutralizing antibody
- Cell-mediated immune profile [ Time Frame: Day 28 post vaccination ]Number of cell-mediated immune response against SARS-CoV-2
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Adults of 18 years old and above.
- Participants who are at high risk of SARS-CoV-2 infection.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures.
- Agreement to refrain from blood donation during the study.
- provide written informed consent.
- Participation in any other COVID-19 prophylactic drug trials for the duration of the study.
- Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
- Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination.
- Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate.
- Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination
- Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines)
- Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use.
- History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV
- Any history of angioedema
- Any history of anaphylaxis to any vaccine component
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition likely to affect participation in the study
- Suspected or known current alcohol or drug dependency
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
- History of laboratory-confirmed COVID-19
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526990
|Principal Investigator:||Scott A Halperin, MD||Canadian Center for Vaccinology|
|Principal Investigator:||Fengcai Zhu||Jiangsu Provincial Center for Disease Control and Prevention|
|Principal Investigator:||Joanne M angley, MD||Canadian Center for Vaccinology|
|Responsible Party:||CanSino Biologics Inc.|
|Other Study ID Numbers:||
|First Posted:||August 26, 2020 Key Record Dates|
|Last Update Posted:||October 31, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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