Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above
- Conditions
- COVID-19
- Interventions
- Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Biological: Placebo
- Registration Number
- NCT04526990
- Lead Sponsor
- CanSino Biologics Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44247
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 20000 participants, Ad5-nCoV , single dose, Intramuscular administration Placebo group Placebo 20000 participants, placebo, single dose, Intramuscular administration
- Primary Outcome Measures
Name Time Method Incidence of SAE Within 12 months Evaluate the incidence of severe adverse events (SAE)
Incidence of COVID-19 cases day 28 to 12 months post vaccination The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease
- Secondary Outcome Measures
Name Time Method Incidence of severe COVID-19 cases 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
Cell-mediated immune profile Day 28 post vaccination Number of cell-mediated immune response against SARS-CoV-2
Incidence of unsolicited adverse events Day 0-28 post vaccination Incidence of unsolicited adverse events within 28 days after vaccination in a subset
Incidence of solicited adverse reactions Day 0-7 post vaccination Incidence of solicited adverse reactions within 7 days after vaccination, in a subset
Immunogencity of S-RBD IgG antibody (ELISA method) Day 28 post vaccination The seroconversion rate of S-RBD IgG antibody post vaccination
Immunogencity of neutralizing antibody Day 28 post vaccination The seroconversion rate of neutralizing antibody
Trial Locations
- Locations (73)
Htal de Alta Complejidad Cuenca Alta Néstor Kirchner
🇦🇷Cañuelas, Buenos Aires, Argentina
Inst. Médico Platense
🇦🇷La Plata, Buenos Aires, Argentina
Clínica Andes Salud Concepción
🇨🇱Concepción, VII Región, Chile
Centro de investigación Médica Aguascalientes (CIMA)
🇲🇽Aguascalientes, Ags, Mexico
JM Research
🇲🇽Cuernavaca, Morelos, Mexico
Hospital Rossi
🇦🇷La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Hospital Interzonal de Agudos "San Juan de Dios" de La Plata
🇦🇷La Plata, Buenos Aires, Argentina
Htal Mariano y Luciano de la Vega
🇦🇷Moreno, Buenos Aires, Argentina
Hospital Houssay
🇦🇷Vicente López, Buenos Aires, Argentina
Instituto Cer
🇦🇷Vicente López, Quilmes, Argentina
Previvax Centro de Vacunación
🇦🇷Córdoba, Argentina
Hospital Dr. Hernan Henriquez Aravena Temuco
🇨🇱Temuco, IX Region, Chile
Hospital San Borja Arriarán Santiago
🇨🇱Santiago, Region Metropolitana, Chile
CIMER Centro de Investigaciones Medicas Respiratorias Santiago
🇨🇱Providencia, Region Metropolitana, Chile
Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)
🇲🇽Tlalpan, Cdmx, Mexico
Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)
🇲🇽Coyoacán, Ciudad De Mexico, Mexico
Instituto Mexicano del Seguro Social (IMSS)
🇲🇽Cuahtemoc, Ciudad De Mexico, Mexico
Clinical Research Institute Saltillo SA de CV
🇲🇽Saltillo, Cuahuila, Mexico
Asociación de investigación pediátrica y adultos (AINPAD)
🇲🇽Morelia, Mochoacán De Ocampo, Mexico
Centro de Investigación y Avances Médicos Especializados (CIAME)
🇲🇽Cancún, Quintana Roo, Mexico
FAICIC
🇲🇽Veracruz, Veracrua, Mexico
Kohler & Milstein Research
🇲🇽Mérida, Yucatan, Mexico
PEMEX
🇲🇽Ciudad de mexico, Mexico
Instituto Nacional de Pediatría (INP)
🇲🇽Ciudad de México, Mexico
Administración de Especialistas de Puebla S.C. (UDEP)
🇲🇽Puebla, Mexico
Shaukat Khanum Memorial Cancer Hospital and Research Centre
🇵🇰Lahore, Punajb, Pakistan
University of Health Scinces, Lahore
🇵🇰Lahore, Punjab, Pakistan
Aga Khan University Hospital
🇵🇰Karachi, Sindh, Pakistan
The Indus Hospital
🇵🇰Karachi, Sindh, Pakistan
Research Center Eco-safety
🇷🇺Saint Petersburg, Saint-Petersburg, Russian Federation
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
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"
🇷🇺Saint Petersburg, Saint-Petersburg, Russian Federation
Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"
🇷🇺Saint Petersburg, Saint-Petersburg, Russian Federation
OOO "Piterclinica"
🇷🇺Saint Petersburg, Saint-Petersburg, Russian Federation
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
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"
🇷🇺Murmansk, Russian Federation
Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"
🇷🇺Nizhniy Novgorod, Russian Federation
"Life Benefits Service, Ltd'
🇷🇺Novosibirsk, Russian Federation
Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."
🇷🇺Omsk, Russian Federation
OOO Zvyezdnaya Klinika
🇷🇺Saint Petersburg, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation
🇷🇺Perm, Russian Federation
Limited Liability Company "Hospital "OrKli"
🇷🇺Saint-Petersburg, Russian Federation
OOO "Tsentr DNK issledivaniy"
🇷🇺Saratov, Russian Federation
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, Russian Federation
OOO "Zdorovye"
🇷🇺Tomsk, Russian Federation
State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"
🇷🇺Yaroslavl, Russian Federation
Fundación Socolinsky Centro de Vacunación Proteger - Recoleta
🇦🇷Caba, Buenos Aires, Argentina
Hospital Pirovano
🇦🇷Caba, Buenos Aires, Argentina
Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt
🇨🇱Puerto Montt, X Región De Los Lagos, Chile
Hospital Base de Osorno
🇨🇱Osorno, XIV Región, Chile
Clinica Alemana de Valdivia Valdivia
🇨🇱Valdivia, XIV Región, Chile
Instituto de Servicios de Salud del Estado de Baja California
🇲🇽Mexicali, Baja California Norte, Mexico
Instituto Nacional de Medicina Genómica
🇲🇽Tlalpan, Cdmx, Mexico
Centro de Investigacion Integral MEDIVEST SC
🇲🇽Chihuahua, Chhihuahia, Mexico
Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
🇲🇽Acapulco, Guerrero, Mexico
Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"
🇷🇺Chelyabinsk, Russian Federation
State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation
🇷🇺Chita, Russian Federation
Hospital Metropolitano "Dr. Bernardo Sepúlveda"
🇲🇽San Nicolás De Los Garza, Nuevo León, Mexico
Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"
🇷🇺Moscow, Russian Federation
Hospital Zonal General de Agudos "Cetrangolo"
🇦🇷Vicente López, Buenos Aires, Argentina
Instituto de Investigaciones aplicada a las Neurociencias (IIAN)
🇲🇽Durango, Mexico
Oaxaca site management organization (OSMO)
🇲🇽Oaxaca, Oax, Mexico
OOO Meditsinskie Tekhnologii
🇷🇺Saint Petersburg, Saint-Petersburg, Russian Federation
State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"
🇷🇺Aramil, Sverdlovsk, Russian Federation
Instituto Jaliscience de Metabolismo, S. C.
🇲🇽Guadalajara, Jalisco, Mexico
Asociación Mexicana para la investigación clínica (AMIC)
🇲🇽Pachuca de Soto, Hidalgo, Mexico
OOO "Baltijskaya Meditsina"
🇷🇺Saint Petersburg, Saint-Petersburg, Russian Federation
Shifa International Hospital
🇵🇰Islamabad, Islamabad Capital Territory, Pakistan
Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation
🇷🇺Moscow, Russian Federation
Health Central Clinical Hospital of Russian Academy of Sciences
🇷🇺Moscow, Russian Federation
Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"
🇷🇺Moscow, Russian Federation