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

June 14, 2023 updated by: CanSino Biologics Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

44247

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Previvax Centro de Vacunación
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1023AAO
        • Fundación Socolinsky Centro de Vacunación Proteger - Recoleta
      • Caba, Buenos Aires, Argentina, C1430BKC
        • Hospital Pirovano
      • Cañuelas, Buenos Aires, Argentina, 1814
        • Htal de Alta Complejidad Cuenca Alta Néstor Kirchner
      • La Plata, Buenos Aires, Argentina, 1900
        • Hospital Interzonal de Agudos "San Juan de Dios" de La Plata
      • La Plata, Buenos Aires, Argentina, 1900
        • Hospital Rossi
      • La Plata, Buenos Aires, Argentina, 1900
        • Inst. Médico Platense
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Instituto de Investigaciones Clinicas
      • Moreno, Buenos Aires, Argentina, 1744
        • Htal Mariano y Luciano de la Vega
      • Vicente López, Buenos Aires, Argentina, 999071
        • Hospital Houssay
      • Vicente López, Buenos Aires, Argentina, 999071
        • Hospital Zonal General de Agudos "Cetrangolo"
    • Quilmes
      • Vicente López, Quilmes, Argentina, 1878
        • Instituto Cer
  • Chile
    • IX Region
      • Temuco, IX Region, Chile, 4780000
        • Hospital Dr. Hernan Henriquez Aravena Temuco
    • Region Metropolitana
      • Providencia, Region Metropolitana, Chile, 7500000
        • CIMER Centro de Investigaciones Medicas Respiratorias Santiago
      • Santiago, Region Metropolitana, Chile, 8320000
        • Hospital San Borja Arriarán Santiago
    • VII Región
      • Concepción, VII Región, Chile, 4030000
        • Clínica Andes Salud Concepción
    • X Región De Los Lagos
      • Puerto Montt, X Región De Los Lagos, Chile, 5480000
        • Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt
    • XIV Región
      • Osorno, XIV Región, Chile, 5290000
        • Hospital Base de Osorno
      • Valdivia, XIV Región, Chile, 5090000
        • Clinica Alemana de Valdivia Valdivia
  • Mexico
      • Ciudad de México, Mexico, 04530
        • Instituto Nacional de Pediatría (INP)
      • Ciudad de mexico, Mexico
        • PEMEX
      • Durango, Mexico, 34000
        • Instituto de Investigaciones aplicada a las Neurociencias (IIAN)
      • Puebla, Mexico, 72160
        • Administración de Especialistas de Puebla S.C. (UDEP)
    • Ags
      • Aguascalientes, Ags, Mexico, 999085
        • Centro de Investigacion Medica Aguascalientes (CIMA)
    • Baja California Norte
      • Mexicali, Baja California Norte, Mexico
        • Instituto de Servicios de Salud del Estado de Baja California
    • Cdmx
      • Tlalpan, Cdmx, Mexico, 14080
        • Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)
      • Tlalpan, Cdmx, Mexico
        • Instituto Nacional de Medicina Genomica
    • Chhihuahia
      • Chihuahua, Chhihuahia, Mexico, 31203
        • Centro de Investigacion Integral Medivest SC
    • Ciudad De Mexico
      • Coyoacán, Ciudad De Mexico, Mexico, 04100
        • Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)
      • Cuahtemoc, Ciudad De Mexico, Mexico
        • Instituto Mexicano del Seguro Social (IMSS)
    • Cuahuila
      • Saltillo, Cuahuila, Mexico, 25020
        • Clinical Research Institute Saltillo SA de CV
    • Guerrero
      • Acapulco, Guerrero, Mexico, 39670
        • Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
    • Hidalgo
      • Pachuca de Soto, Hidalgo, Mexico, 42070
        • Asociación Mexicana para la investigación clínica (AMIC)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Instituto Jaliscience de Metabolismo, S. C.
    • Mochoacán De Ocampo
      • Morelia, Mochoacán De Ocampo, Mexico, 58350
        • Asociación de investigación pediátrica y adultos (AINPAD)
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • JM Research
    • Nuevo León
      • San Nicolás De Los Garza, Nuevo León, Mexico, 66480
        • Hospital Metropolitano "Dr. Bernardo Sepúlveda"
    • Oax
      • Oaxaca, Oax, Mexico, 68000
        • Oaxaca Site Management Organization (OSMO)
    • Quintana Roo
      • Cancún, Quintana Roo, Mexico, 999085
        • Centro de Investigación y Avances Médicos Especializados (CIAME)
    • Veracrua
      • Veracruz, Veracrua, Mexico, 91900
        • FAICIC
    • Yucatan
      • Mérida, Yucatan, Mexico, 97070
        • Köhler & Milstein Research
  • Pakistan
    • Islamabad Capital Territory
      • Islamabad, Islamabad Capital Territory, Pakistan, 30001
        • Shifa International Hospital
    • Punajb
      • Lahore, Punajb, Pakistan, 54000
        • Shaukat Khanum Memorial Cancer Hospital and Research Centre
    • Punjab
      • Lahore, Punjab, Pakistan, 999010
        • University of Health Scinces, Lahore
    • Sindh
      • Karachi, Sindh, Pakistan, 999010
        • Aga Khan University Hospital
      • Karachi, Sindh, Pakistan, 999010
        • The Indus Hospital
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454000
        • Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"
      • Chita, Russian Federation, 672000
        • State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation
      • Moscow, Russian Federation, 105229
        • Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation
      • Moscow, Russian Federation, 117556
        • Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"
      • Moscow, Russian Federation, 117593
        • Health Central Clinical Hospital of Russian Academy of Sciences
      • Moscow, Russian Federation, 119435
        • Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of Ministry of Healthcare of the Russian Federation (Sechenovsky University)
      • Moscow, Russian Federation
        • Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"
      • Murmansk, Russian Federation, 183047
        • State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin"
      • Murmansk, Russian Federation
        • State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital"
      • Nizhniy Novgorod, Russian Federation, 603140
        • Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"
      • Novosibirsk, Russian Federation, 630091
        • "Life Benefits Service, Ltd'
      • Omsk, Russian Federation, 644112
        • Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."
      • Perm, Russian Federation, 614070
        • Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation
      • Saint Petersburg, Russian Federation, 196158
        • OOO Zvyezdnaya Klinika
      • Saint-Petersburg, Russian Federation, 199178
        • Limited Liability Company "Hospital "OrKli"
      • Saratov, Russian Federation, 410005
        • OOO "Tsentr DNK issledivaniy"
      • Saratov, Russian Federation, 410054
        • Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" the Ministry of Health of the Russian Federation - Clinical hospital n.a. S.R.Mirotvortseva
      • Tomsk, Russian Federation
        • OOO "Zdorovye"
      • Yaroslavl, Russian Federation, 150003
        • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"
    • Saint-Petersburg
      • Saint Petersburg, Saint-Petersburg, Russian Federation, 191119
        • Research Center Eco-Safety
      • Saint Petersburg, Saint-Petersburg, Russian Federation, 192148
        • OOO Meditsinskie Tekhnologii
      • Saint Petersburg, Saint-Petersburg, Russian Federation, 194356
        • OOO "Baltijskaya Meditsina"
      • Saint Petersburg, Saint-Petersburg, Russian Federation, 196143
        • Research Center Eco-Safety
      • Saint Petersburg, Saint-Petersburg, Russian Federation, 197376
        • Federal State Budgetary Institution "Scientific Research Institute of Influenza named after A. A. Smorodintsev" of the Ministry of Healthcare of the Russian Federation named after A. A. Smorodintsev" of the Ministry of Healthcare of the Russian Federation
      • Saint Petersburg, Saint-Petersburg, Russian Federation, 198328
        • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"
      • Saint Petersburg, Saint-Petersburg, Russian Federation, 198510
        • Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"
      • Saint Petersburg, Saint-Petersburg, Russian Federation
        • OOO "Piterclinica"
    • Sverdlovsk
      • Aramil, Sverdlovsk, Russian Federation, 624002
        • State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 28 to 12 months post vaccination
Incidence of SAE
Time Frame: Within 12 months
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
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
Day 14 to 12 months post vaccination
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
Day 0-7 post vaccination
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
Day 0-28 post vaccination
Immunogencity of S-RBD IgG antibody (ELISA method)
Time Frame: Day 28 post vaccination
The seroconversion rate of S-RBD IgG antibody post vaccination
Day 28 post vaccination
Immunogencity of neutralizing antibody
Time Frame: Day 28 post vaccination
The seroconversion rate of neutralizing antibody
Day 28 post vaccination
Cell-mediated immune profile
Time Frame: Day 28 post vaccination
Number of cell-mediated immune response against SARS-CoV-2
Day 28 post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CanSino Biologics Inc.

Collaborators

Beijing Institute of Biotechnology

Investigators

  • Principal Investigator: Fengcai Zhu, Jiangsu Provincial Center for Disease Control and Prevention
  • Principal Investigator: Scott A Halperin, MD, Canadian Center for Vaccinology
  • Principal Investigator: Joanne M angley, MD, Canadian Center for Vaccinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

August 7, 2021

Study Completion (Actual)

October 21, 2022

Study Registration Dates

First Submitted

August 22, 2020

First Submitted That Met QC Criteria

August 22, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-CTP-AD5NCOV-Ⅲ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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