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

NCT04526990 | Completed Phase 3 DMC

• 1 other identifier: CS-CTP-AD5NCOV-Ⅲ
• Study Type: interventional
• Target: 44,247
• Locations: 5 countries
• Sites: 74

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.

Conditions

COVID-19

Keywords

COVID-19; vaccine; Ad5; Safety; Immunogencity; efficacy; adaptive design; SARS-CoV-2; Adenovirus Vector

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Incidence of severe COVID-19 cases

  Day 14 to 12 months post vaccination

• Incidence of solicited adverse reactions

  Day 0-7 post vaccination

• Incidence of unsolicited adverse events

  Day 0-28 post vaccination

• Immunogencity of S-RBD IgG antibody (ELISA method)

  Day 28 post vaccination

• Immunogencity of neutralizing antibody

  Day 28 post vaccination

Study Arms (2)

Experimental group

EXPERIMENTAL

20000 participants, Ad5-nCoV , single dose, Intramuscular administration

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Placebo group

PLACEBO COMPARATOR

20000 participants, placebo, single dose, Intramuscular administration

Biological: Placebo

Interventions

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) BIOLOGICAL

Intramuscular administration

Experimental group

Placebo BIOLOGICAL

Intramuscular administration

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Beijing Institute of Biotechnology: collaborator

Study Sites (74)

Fundación Socolinsky Centro de Vacunación Proteger - Recoleta

CABA, Buenos Aires, C1023AAO, Argentina

Location

Hospital Pirovano

CABA, Buenos Aires, C1430BKC, Argentina

Location

Htal de Alta Complejidad Cuenca Alta Néstor Kirchner

Cañuelas, Buenos Aires, 1814, Argentina

Location

Hospital Interzonal de Agudos "San Juan de Dios" de La Plata

La Plata, Buenos Aires, 1900, Argentina

Location

Hospital Rossi

La Plata, Buenos Aires, 1900, Argentina

Location

Inst. Médico Platense

La Plata, Buenos Aires, 1900, Argentina

Location

Instituto de Investigaciones Clínicas

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Htal Mariano y Luciano de la Vega

Moreno, Buenos Aires, 1744, Argentina

Location

Hospital Houssay

Vicente López, Buenos Aires, 999071, Argentina

Location

Hospital Zonal General de Agudos "Cetrangolo"

Vicente López, Buenos Aires, 999071, Argentina

Location

Instituto Cer

Vicente López, Quilmes, 1878, Argentina

Location

Previvax Centro de Vacunación

Córdoba, 5000, Argentina

Location

Hospital Base de Osorno

Osorno, Los Ríos Region, 5290000, Chile

Location

Clinica Alemana de Valdivia Valdivia

Valdivia, Los Ríos Region, 5090000, Chile

Location

Clínica Andes Salud Concepción

Concepción, Maule Region, 4030000, Chile

Location

Hospital Dr. Hernan Henriquez Aravena Temuco

Temuco, Región de la Araucanía, 4780000, Chile

Location

CIMER Centro de Investigaciones Medicas Respiratorias Santiago

Providencia, Santiago Metropolitan, 7500000, Chile

Location

Hospital San Borja Arriarán Santiago

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt

Port Montt, X Región de Los Lagos, 5480000, Chile

Location

Centro de investigación Médica Aguascalientes (CIMA)

Aguascalientes, Aguascalientes, 999085, Mexico

Location

Instituto de Servicios de Salud del Estado de Baja California

Mexicali, Baja California Norte, Mexico

Location

Centro de Investigacion Integral MEDIVEST SC

Chihuahua City, Chhihuahia, 31203, Mexico

Location

Clinical Research Institute Saltillo SA de CV

Saltillo, Cuahuila, 25020, Mexico

Location

Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

Asociación Mexicana para la investigación clínica (AMIC)

Pachuca, Hidalgo, 42070, Mexico

Location

Instituto Jaliscience de Metabolismo, S. C.

Guadalajara, Jalisco, 44670, Mexico

Location

Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)

Coyoacán, Mexico City, 04100, Mexico

Location

Instituto Mexicano del Seguro Social (IMSS)

Cuahtemoc, Mexico City, Mexico

Location

Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)

Tlalpan, Mexico City, 14080, Mexico

Location

Instituto Nacional de Medicina Genómica

Tlalpan, Mexico City, Mexico

Location

Asociación de investigación pediátrica y adultos (AINPAD)

Morelia, Mochoacán de Ocampo, 58350, Mexico

Location

JM Research

Cuernavaca, Morelos, 62290, Mexico

Location

Hospital Metropolitano "Dr. Bernardo Sepúlveda"

San Nicolás de los Garza, Nuevo León, 66480, Mexico

Location

Oaxaca site management organization (OSMO)

Oaxaca City, Oaxaca, 68000, Mexico

Location

Centro de Investigación y Avances Médicos Especializados (CIAME)

Cancún, Quintana Roo, 999085, Mexico

Location

FAICIC

Veracruz, Veracrua, 91900, Mexico

Location

Kohler & Milstein Research

Mérida, Yucatán, 97070, Mexico

Location

Instituto de Investigaciones aplicada a las Neurociencias (IIAN)

Durango, 34000, Mexico

Location

Instituto Nacional de Pediatría (INP)

Mexico City, 04530, Mexico

Location

PEMEX

Mexico City, Mexico

Location

Administración de Especialistas de Puebla S.C. (UDEP)

Puebla City, 72160, Mexico

Location

Shifa International Hospital

Islamabad, Islamabad, 30001, Pakistan

Location

Shaukat Khanum Memorial Cancer Hospital and Research Centre

Lahore, Punajb, 54000, Pakistan

Location

University of Health Scinces, Lahore

Lahore, Punjab Province, 999010, Pakistan

Location

Aga Khan University Hospital

Karachi, Sindh, 999010, Pakistan

Location

The Indus Hospital

Karachi, Sindh, 999010, Pakistan

Location

Research Center Eco-safety

Saint Petersburg, Sankt-Peterburg, 191119, Russia

Location

OOO Meditsinskie Tekhnologii

Saint Petersburg, Sankt-Peterburg, 192148, Russia

Location

OOO "Baltijskaya Meditsina"

Saint Petersburg, Sankt-Peterburg, 194356, Russia

Location

Research Center Eco-safety

Saint Petersburg, Sankt-Peterburg, 196143, Russia

Location

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, Sankt-Peterburg, 197376, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"

Saint Petersburg, Sankt-Peterburg, 198328, Russia

Location

Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"

Saint Petersburg, Sankt-Peterburg, 198510, Russia

Location

OOO "Piterclinica"

Saint Petersburg, Sankt-Peterburg, Russia

Location

State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"

Aramil, Sverdlovsk Oblast, 624002, Russia

Location

Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"

Chelyabinsk, 454000, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation

Chita, 672000, Russia

Location

Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation

Moscow, 105229, Russia

Location

Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"

Moscow, 117556, Russia

Location

Health Central Clinical Hospital of Russian Academy of Sciences

Moscow, 117593, Russia

Location

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, 119435, Russia

Location

Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"

Moscow, Russia

Location

State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin"

Murmansk, 183047, Russia

Location

State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital"

Murmansk, Russia

Location

Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"

Nizhny Novgorod, 603140, Russia

Location

"Life Benefits Service, Ltd'

Novosibirsk, 630091, Russia

Location

Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."

Omsk, 644112, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation

Perm, 614070, Russia

Location

OOO Zvyezdnaya Klinika

Saint Petersburg, 196158, Russia

Location

Limited Liability Company "Hospital "OrKli"

Saint Petersburg, 199178, Russia

Location

OOO "Tsentr DNK issledivaniy"

Saratov, 410005, Russia

Location

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

Saratov, 410054, Russia

Location

OOO "Zdorovye"

Tomsk, Russia

Location

State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"

Yaroslavl, 150003, Russia

Location

Related Publications (1)

• 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.

  PMID: 34953526 DERIVED

MeSH Terms

Conditions

COVID-19; Alzheimer Disease 5

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 26, 2020
• Study Start: September 15, 2020
• Primary Completion: August 7, 2021
• Study Completion: October 21, 2022
• Last Updated: June 15, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (28); AR (12); ME (22); CL (7); PA (5)