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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04526990
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Beijing Institute of Biotechnology
Information provided by (Responsible Party):
CanSino Biologics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Biological: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : January 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
20000 participants, Ad5-nCoV , single dose, Intramuscular administration
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration

Placebo Comparator: Placebo group
20000 participants, placebo, single dose, Intramuscular administration
Biological: Placebo
Intramuscular administration



Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Incidence of SAE [ Time Frame: Within 12 months ]
    Evaluate the incidence of severe adverse events (SAE)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Immunogencity of S-RBD IgG antibody (ELISA method) [ Time Frame: Day 28 post vaccination ]
    The seroconversion rate of S-RBD IgG antibody post vaccination

  5. Immunogencity of neutralizing antibody [ Time Frame: Day 28 post vaccination ]
    The seroconversion rate of neutralizing antibody

  6. Cell-mediated immune profile [ Time Frame: Day 28 post vaccination ]
    Number of cell-mediated immune response against SARS-CoV-2


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jinbo Gou, MD +86-022-58213600-6051 jinbo.gou@cansinotech.com

Locations
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Pakistan
Shaukat Khanum Memorial Cancer Hospital and Research Centre Recruiting
Islamabad, Norhern Punajb Rawalpindi, Pakistan, 30001
Contact: Aamer Ikram SI, phD    +923215170713    maahin1@yahoo.com   
Principal Investigator: Aamer Ikram SI, phD         
Sponsors and Collaborators
CanSino Biologics Inc.
Beijing Institute of Biotechnology
Investigators
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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
More Information
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT04526990    
Other Study ID Numbers: CS-CTP-AD5NCOV-Ⅲ
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
COVID-19
vaccine
Ad5
Safety
Immunogencity
 efficacy
adaptive design
SARS-CoV-2
Adenovirus Vector