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

• ClinicalTrials.gov Identifier: NCT04526990
• Recruitment Status: Active, not recruiting
• First Posted: August 26, 2020
• Last Update Posted: October 31, 2022
• Sponsor: CanSino Biologics Inc.
• Collaborator: Beijing Institute of Biotechnology
• Information provided by (Responsible Party): CanSino Biologics Inc.

Tracking Information

• First Submitted Date: August 22, 2020
• First Posted Date: August 26, 2020
• Last Update Posted Date: October 31, 2022
• Actual Study Start Date: September 15, 2020
• Actual Primary Completion Date: August 7, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  Intramuscular administration
• Biological: Placebo
  Intramuscular administration

Study Arms

• 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 *: Halperin SA, Ye L, MacKinnon-Cameron D, Smith B, Cahn PE, Ruiz-Palacios GM, Ikram A, Lanas F, Lourdes Guerrero M, Munoz Navarro SR, Sued O, Lioznov DA, Dzutseva V, Parveen G, Zhu F, Leppan L, Langley JM, Barreto L, Gou J, Zhu T; CanSino COVID-19 Global Efficacy Study Group. 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-controlled phase 3 trial. Lancet. 2022 Jan 15;399(10321):237-248. doi: 10.1016/S0140-6736(21)02753-7. Epub 2021 Dec 23. Erratum In: Lancet. 2022 Jan 15;399(10321):236.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 22, 2020): 40000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2022
• Actual Primary Completion Date: August 7, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Chile, Mexico, Pakistan, Russian Federation

Administrative Information

• NCT Number: NCT04526990
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: CanSino Biologics Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: CanSino Biologics Inc.
• Original Study Sponsor: Same as current
• Collaborators: Beijing Institute of Biotechnology

Investigators

• 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: September 2022