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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526990
• Other study ID #: CS-CTP-AD5NCOV-?
• Status: Completed
• Phase: Phase 3
• Start date: September 15, 2020
• Est. completion date: October 21, 2022

Study information

• Verified date: September 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
• Placebo
Intramuscular administration

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Beijing Institute of Biotechnology

Countries where clinical trial is conducted

Argentina,  Chile,  Mexico,  Pakistan,  Russian Federation, 

Outcome

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