COVID-19 Clinical Trial
Official title:
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
| Verified date | September 2022 |
| Source | CanSino Biologics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 44247 |
| Est. completion date | October 21, 2022 |
| Est. primary completion date | August 7, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 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 | Previvax Centro de Vacunación | Córdoba | |
| 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 |
| Chile | Clínica Andes Salud Concepción | Concepción | VII Región |
| Chile | Hospital Base de Osorno | Osorno | XIV Región |
| Chile | CIMER Centro de Investigaciones Medicas Respiratorias Santiago | Providencia | Region Metropolitana |
| Chile | Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt | Puerto Montt | X Región De Los Lagos |
| Chile | Hospital San Borja Arriarán Santiago | Santiago | Region Metropolitana |
| Chile | Hospital Dr. Hernan Henriquez Aravena Temuco | Temuco | IX Region |
| Chile | Clinica Alemana de Valdivia Valdivia | Valdivia | XIV Región |
| Mexico | Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA) | Acapulco | Guerrero |
| Mexico | Centro de investigación Médica Aguascalientes (CIMA) | Aguascalientes | Ags |
| Mexico | Centro de Investigación y Avances Médicos Especializados (CIAME) | Cancún | Quintana Roo |
| Mexico | Centro de Investigacion Integral MEDIVEST SC | Chihuahua | Chhihuahia |
| Mexico | PEMEX | Ciudad de mexico | |
| Mexico | Instituto Nacional de Pediatría (INP) | Ciudad de México | |
| 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 | JM Research | Cuernavaca | Morelos |
| Mexico | Instituto de Investigaciones aplicada a las Neurociencias (IIAN) | Durango | |
| Mexico | Instituto Jaliscience de Metabolismo, S. C. | Guadalajara | Jalisco |
| Mexico | Kohler & Milstein Research | Mérida | Yucatan |
| Mexico | Instituto de Servicios de Salud del Estado de Baja California | Mexicali | Baja California Norte |
| Mexico | Asociación de investigación pediátrica y adultos (AINPAD) | Morelia | Mochoacán De Ocampo |
| Mexico | Oaxaca site management organization (OSMO) | Oaxaca | Oax |
| Mexico | Asociación Mexicana para la investigación clínica (AMIC) | Pachuca de Soto | Hidalgo |
| Mexico | Administración de Especialistas de Puebla S.C. (UDEP) | Puebla | |
| Mexico | Clinical Research Institute Saltillo SA de CV | Saltillo | Cuahuila |
| Mexico | Hospital Metropolitano "Dr. Bernardo Sepúlveda" | San Nicolás De Los Garza | Nuevo León |
| Mexico | Instituto Nacional de Medicina Genómica | Tlalpan | Cdmx |
| Mexico | Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ) | Tlalpan | Cdmx |
| Mexico | FAICIC | Veracruz | Veracrua |
| Pakistan | Shifa International Hospital | Islamabad | Islamabad Capital Territory |
| Pakistan | Aga Khan University Hospital | Karachi | Sindh |
| Pakistan | The Indus Hospital | Karachi | Sindh |
| Pakistan | Shaukat Khanum Memorial Cancer Hospital and Research Centre | Lahore | Punajb |
| Pakistan | University of Health Scinces, Lahore | Lahore | Punjab |
| 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 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 | 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 | Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department" | Moscow | |
| Russian Federation | Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine" | Moscow | |
| Russian Federation | State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital" | Murmansk | |
| Russian Federation | State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin" | 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 | 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 | OOO "Baltijskaya Meditsina" | Saint Petersburg | Saint-Petersburg |
| Russian Federation | OOO "Piterclinica" | Saint Petersburg | Saint-Petersburg |
| Russian Federation | OOO Meditsinskie Tekhnologii | Saint Petersburg | Saint-Petersburg |
| Russian Federation | OOO Zvyezdnaya Klinika | Saint Petersburg | |
| Russian Federation | Research Center Eco-safety | Saint Petersburg | Saint-Petersburg |
| Russian Federation | Research Center Eco-safety | 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 | Limited Liability Company "Hospital "OrKli" | Saint-Petersburg | |
| 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 "Tsentr DNK issledivaniy" | Saratov | |
| Russian Federation | OOO "Zdorovye" | Tomsk | |
| Russian Federation | State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev" | Yaroslavl |
| Lead Sponsor | Collaborator |
|---|---|
| CanSino Biologics Inc. | Beijing Institute of Biotechnology |
Argentina, Chile, Mexico, Pakistan, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Incidence of SAE | Evaluate the incidence of severe adverse events (SAE) | Within 12 months | |
| Secondary | Incidence of severe COVID-19 cases | 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 | |
| Secondary | Incidence of solicited adverse reactions | Incidence of solicited adverse reactions within 7 days after vaccination, in a subset | Day 0-7 post vaccination | |
| Secondary | Incidence of unsolicited adverse events | Incidence of unsolicited adverse events within 28 days after vaccination in a subset | Day 0-28 post vaccination | |
| Secondary | Immunogencity of S-RBD IgG antibody (ELISA method) | The seroconversion rate of S-RBD IgG antibody post vaccination | Day 28 post vaccination | |
| Secondary | Immunogencity of neutralizing antibody | The seroconversion rate of neutralizing antibody | Day 28 post vaccination | |
| Secondary | Cell-mediated immune profile | Number of cell-mediated immune response against SARS-CoV-2 | Day 28 post vaccination |
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