Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above

Study Overview
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Brief Summary
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This study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.

Detailed Description
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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).

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>20000 participants, Ad5-nCoV , single dose, Intramuscular administration | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)<br>* Intramuscular administration<br>|
| Placebo Comparator: Placebo group<br>20000 participants, placebo, single dose, Intramuscular administration | Biological: Placebo<br>* Intramuscular administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 cases | The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease | day 28 to 12 months post vaccination | 
| Incidence of SAE | Evaluate the incidence of severe adverse events (SAE) | Within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe COVID-19 cases | Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection | Day 14 to 12 months post vaccination | 
| Incidence of solicited adverse reactions | Incidence of solicited adverse reactions within 7 days after vaccination, in a subset | Day 0-7 post vaccination | 
| Incidence of unsolicited adverse events | Incidence of unsolicited adverse events within 28 days after vaccination in a subset | Day 0-28 post vaccination | 
| Immunogencity of S-RBD IgG antibody (ELISA method) | The seroconversion rate of S-RBD IgG antibody post vaccination | Day 28 post vaccination | 
| Immunogencity of neutralizing antibody | The seroconversion rate of neutralizing antibody | Day 28 post vaccination | 
| Cell-mediated immune profile | Number of cell-mediated immune response against SARS-CoV-2 | Day 28 post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, COVID-19, Ad5, Safety, Immunogencity, efficacy, adaptive design, SARS-CoV-2, Adenovirus Vector