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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 : Recruiting
First Posted : August 26, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Beijing Institute of Biotechnology
Information provided by (Responsible Party):
CanSino Biologics Inc.

Tracking Information
First Submitted Date  ICMJE August 22, 2020
First Posted Date  ICMJE August 26, 2020
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2020)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above
Official Title  ICMJE 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
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    Intramuscular administration
  • Biological: Placebo
    Intramuscular administration
Study Arms  ICMJE
  • Experimental: Experimental group
    20000 participants, Ad5-nCoV , single dose, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Placebo group
    20000 participants, placebo, single dose, Intramuscular administration
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2020)
40000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jinbo Gou, MD +86-022-58213600-6051 jinbo.gou@cansinotech.com
Listed Location Countries  ICMJE Argentina,   Chile,   Mexico,   Pakistan,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04526990
Other Study ID Numbers  ICMJE CS-CTP-AD5NCOV-Ⅲ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CanSino Biologics Inc.
Study Sponsor  ICMJE CanSino Biologics Inc.
Collaborators  ICMJE Beijing Institute of Biotechnology
Investigators  ICMJE
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
PRS Account CanSino Biologics Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP