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.
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).
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Biological: Placebo
Intramuscular administration
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.
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 Dr. Hernan Henriquez Aravena Temuco
Temuco, IX Region, Chile
CIMER Centro de Investigaciones Medicas Respiratorias Santiago
Providencia, Region Metropolitana, Chile
Hospital San Borja Arriarán Santiago
Santiago, Region Metropolitana, Chile
Clínica Andes Salud Concepción
Concepción, VII Región, Chile
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
Centro de investigación Médica Aguascalientes (CIMA)
Aguascalientes, Ags, Mexico
Instituto de Servicios de Salud del Estado de Baja California
Mexicali, Baja California Norte, Mexico
Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)
Tlalpan, Cdmx, Mexico
Instituto Nacional de Medicina Genómica
Tlalpan, Cdmx, Mexico
Centro de Investigacion Integral MEDIVEST SC
Chihuahua, Chhihuahia, 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
Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
Acapulco, Guerrero, Mexico
Asociación Mexicana para la investigación clínica (AMIC)
Pachuca de Soto, Hidalgo, Mexico
Instituto Jaliscience de Metabolismo, S. C.
Guadalajara, Jalisco, 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, Oax, 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
Instituto de Investigaciones aplicada a las Neurociencias (IIAN)
Durango, Mexico
Administración de Especialistas de Puebla S.C. (UDEP)
Puebla, Mexico
Shifa International Hospital
Islamabad, Islamabad Capital Territory, Pakistan
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
OOO Meditsinskie Tekhnologii
Saint Petersburg, Saint-Petersburg, Russian Federation
OOO "Baltijskaya Meditsina"
Saint Petersburg, Saint-Petersburg, Russian Federation
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
State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"
Aramil, Sverdlovsk, Russian Federation
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
Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation
Moscow, Russian Federation
Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"
Moscow, Russian Federation
Health Central Clinical Hospital of Russian Academy of Sciences
Moscow, 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
Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"
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
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
OOO Zvyezdnaya Klinika
Saint Petersburg, 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