Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above
NCT ID: NCT04526990
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
44247 participants
INTERVENTIONAL
2020-09-15
2022-10-21
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental group
20000 participants, Ad5-nCoV , single dose, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Placebo group
20000 participants, placebo, single dose, Intramuscular administration
Placebo
Intramuscular administration
Interventions
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Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Placebo
Intramuscular administration
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Beijing Institute of Biotechnology
OTHER
CanSino Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Scott A Halperin, MD
Role: PRINCIPAL_INVESTIGATOR
Canadian Center for Vaccinology
Fengcai Zhu
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Control and Prevention
Joanne M angley, MD
Role: PRINCIPAL_INVESTIGATOR
Canadian Center for Vaccinology
Locations
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Fundación Socolinsky Centro de Vacunación Proteger - Recoleta
CABA, Buenos Aires, Argentina
Hospital Pirovano
CABA, Buenos Aires, Argentina
Htal de Alta Complejidad Cuenca Alta Néstor Kirchner
Cañuelas, Buenos Aires, Argentina
Hospital Interzonal de Agudos "San Juan de Dios" de La Plata
La Plata, Buenos Aires, Argentina
Hospital Rossi
La Plata, Buenos Aires, Argentina
Inst. Médico Platense
La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas
Mar del Plata, Buenos Aires, Argentina
Htal Mariano y Luciano de la Vega
Moreno, Buenos Aires, Argentina
Hospital Houssay
Vicente López, Buenos Aires, Argentina
Hospital Zonal General de Agudos "Cetrangolo"
Vicente López, Buenos Aires, Argentina
Instituto Cer
Vicente López, Quilmes, Argentina
Previvax Centro de Vacunación
Córdoba, , Argentina
Hospital Base de Osorno
Osorno, Los Ríos Region, Chile
Clinica Alemana de Valdivia Valdivia
Valdivia, Los Ríos Region, Chile
Clínica Andes Salud Concepción
Concepción, Maule Region, Chile
Hospital Dr. Hernan Henriquez Aravena Temuco
Temuco, Región de la Araucanía, Chile
CIMER Centro de Investigaciones Medicas Respiratorias Santiago
Providencia, Santiago Metropolitan, Chile
Hospital San Borja Arriarán Santiago
Santiago, Santiago Metropolitan, Chile
Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt
Port Montt, X Región de Los Lagos, Chile
Centro de investigación Médica Aguascalientes (CIMA)
Aguascalientes, Aguascalientes, Mexico
Instituto de Servicios de Salud del Estado de Baja California
Mexicali, Baja California Norte, Mexico
Centro de Investigacion Integral MEDIVEST SC
Chihuahua City, Chhihuahia, Mexico
Clinical Research Institute Saltillo SA de CV
Saltillo, Cuahuila, Mexico
Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
Acapulco de Juárez, Guerrero, Mexico
Asociación Mexicana para la investigación clínica (AMIC)
Pachuca, Hidalgo, Mexico
Instituto Jaliscience de Metabolismo, S. C.
Guadalajara, Jalisco, Mexico
Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)
Coyoacán, Mexico City, Mexico
Instituto Mexicano del Seguro Social (IMSS)
Cuahtemoc, Mexico City, Mexico
Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)
Tlalpan, Mexico City, Mexico
Instituto Nacional de Medicina Genómica
Tlalpan, Mexico City, Mexico
Asociación de investigación pediátrica y adultos (AINPAD)
Morelia, Mochoacán de Ocampo, Mexico
JM Research
Cuernavaca, Morelos, Mexico
Hospital Metropolitano "Dr. Bernardo Sepúlveda"
San Nicolás de los Garza, Nuevo León, Mexico
Oaxaca site management organization (OSMO)
Oaxaca City, Oaxaca, Mexico
Centro de Investigación y Avances Médicos Especializados (CIAME)
Cancún, Quintana Roo, Mexico
FAICIC
Veracruz, Veracrua, Mexico
Kohler & Milstein Research
Mérida, Yucatán, Mexico
Instituto de Investigaciones aplicada a las Neurociencias (IIAN)
Durango, , Mexico
Instituto Nacional de Pediatría (INP)
Mexico City, , Mexico
PEMEX
Mexico City, , Mexico
Administración de Especialistas de Puebla S.C. (UDEP)
Puebla City, , Mexico
Shifa International Hospital
Islamabad, Islamabad, Pakistan
Shaukat Khanum Memorial Cancer Hospital and Research Centre
Lahore, Punajb, Pakistan
University of Health Scinces, Lahore
Lahore, Punjab Province, Pakistan
Aga Khan University Hospital
Karachi, Sindh, Pakistan
The Indus Hospital
Karachi, Sindh, Pakistan
Research Center Eco-safety
Saint Petersburg, Sankt-Peterburg, Russia
OOO Meditsinskie Tekhnologii
Saint Petersburg, Sankt-Peterburg, Russia
OOO "Baltijskaya Meditsina"
Saint Petersburg, Sankt-Peterburg, Russia
Research Center Eco-safety
Saint Petersburg, Sankt-Peterburg, Russia
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, Russia
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"
Saint Petersburg, Sankt-Peterburg, Russia
Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"
Saint Petersburg, Sankt-Peterburg, Russia
OOO "Piterclinica"
Saint Petersburg, Sankt-Peterburg, Russia
State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"
Aramil, Sverdlovsk Oblast, Russia
Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"
Chelyabinsk, , Russia
State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation
Chita, , Russia
Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation
Moscow, , Russia
Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"
Moscow, , Russia
Health Central Clinical Hospital of Russian Academy of Sciences
Moscow, , Russia
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, , Russia
Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"
Moscow, , Russia
State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin"
Murmansk, , Russia
State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital"
Murmansk, , Russia
Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"
Nizhny Novgorod, , Russia
"Life Benefits Service, Ltd'
Novosibirsk, , Russia
Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."
Omsk, , Russia
Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation
Perm, , Russia
OOO Zvyezdnaya Klinika
Saint Petersburg, , Russia
Limited Liability Company "Hospital "OrKli"
Saint Petersburg, , Russia
OOO "Tsentr DNK issledivaniy"
Saratov, , Russia
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, , Russia
OOO "Zdorovye"
Tomsk, , Russia
State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"
Yaroslavl, , Russia
Countries
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References
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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.
Other Identifiers
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CS-CTP-AD5NCOV-Ⅲ
Identifier Type: -
Identifier Source: org_study_id
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