Clinical trial NCT04526990: Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
vaccine
Ad5
Safety
Immunogencity
efficacy
adaptive design
SARS-CoV-2
Adenovirus Vector
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Institute of Biotechnology
First posted: 2020-08-26
Enrollment: 44247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of COVID-19 cases
timeFrame: day 28 to 12 months post vaccination
measure: Incidence of SAE
timeFrame: Within 12 months
Secondary outcomes:
measure: Incidence of severe COVID-19 cases
timeFrame: Day 14 to 12 months post vaccination
measure: Incidence of solicited adverse reactions
timeFrame: Day 0-7 post vaccination
measure: Incidence of unsolicited adverse events
timeFrame: Day 0-28 post vaccination
measure: Immunogencity of S-RBD IgG antibody (ELISA method)
timeFrame: Day 28 post vaccination
measure: Immunogencity of neutralizing antibody
timeFrame: Day 28 post vaccination
measure: Cell-mediated immune profile
timeFrame: Day 28 post vaccination
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Fundación Socolinsky Centro de Vacunación Proteger - Recoleta
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Pirovano
state: Buenos Aires
city: Cañuelas
country: Argentina
facility: Htal de Alta Complejidad Cuenca Alta Néstor Kirchner
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Interzonal de Agudos "San Juan de Dios" de La Plata
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Rossi
state: Buenos Aires
city: La Plata
country: Argentina
facility: Inst. Médico Platense
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas
state: Buenos Aires
city: Moreno
country: Argentina
facility: Htal Mariano y Luciano de la Vega
state: Buenos Aires
city: Vicente López
country: Argentina
facility: Hospital Houssay
state: Buenos Aires
city: Vicente López
country: Argentina
facility: Hospital Zonal General de Agudos "Cetrangolo"
state: Buenos Aires
city: Vicente López
country: Argentina
facility: Instituto Cer
state: Quilmes
city: Córdoba
country: Argentina
facility: Previvax Centro de Vacunación
city: Temuco
country: Chile
facility: Hospital Dr. Hernan Henriquez Aravena Temuco
state: IX Region
city: Providencia
country: Chile
facility: CIMER Centro de Investigaciones Medicas Respiratorias Santiago
state: Region Metropolitana
city: Santiago
country: Chile
facility: Hospital San Borja Arriarán Santiago
state: Region Metropolitana
city: Concepción
country: Chile
facility: Clínica Andes Salud Concepción
state: VII Región
city: Puerto Montt
country: Chile
facility: Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt
state: X Región De Los Lagos
city: Osorno
country: Chile
facility: Hospital Base de Osorno
state: XIV Región
city: Valdivia
country: Chile
facility: Clinica Alemana de Valdivia Valdivia
state: XIV Región
city: Aguascalientes
country: Mexico
facility: Centro de investigación Médica Aguascalientes (CIMA)
state: Ags
city: Mexicali
country: Mexico
facility: Instituto de Servicios de Salud del Estado de Baja California
state: Baja California Norte
city: Tlalpan
country: Mexico
facility: Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)
state: Cdmx
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Medicina Genómica
state: Cdmx
city: Chihuahua
country: Mexico
facility: Centro de Investigacion Integral MEDIVEST SC
state: Chhihuahia
city: Coyoacán
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)
state: Ciudad De Mexico
city: Cuahtemoc
country: Mexico
facility: Instituto Mexicano del Seguro Social (IMSS)
state: Ciudad De Mexico
city: Saltillo
country: Mexico
facility: Clinical Research Institute Saltillo SA de CV
state: Cuahuila
city: Acapulco
country: Mexico
facility: Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
state: Guerrero
city: Pachuca de Soto
country: Mexico
facility: Asociación Mexicana para la investigación clínica (AMIC)
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Instituto Jaliscience de Metabolismo, S. C.
state: Jalisco
city: Morelia
country: Mexico
facility: Asociación de investigación pediátrica y adultos (AINPAD)
state: Mochoacán De Ocampo
city: Cuernavaca
country: Mexico
facility: JM Research
state: Morelos
city: San Nicolás De Los Garza
country: Mexico
facility: Hospital Metropolitano "Dr. Bernardo Sepúlveda"
state: Nuevo León
city: Oaxaca
country: Mexico
facility: Oaxaca site management organization (OSMO)
state: Oax
city: Cancún
country: Mexico
facility: Centro de Investigación y Avances Médicos Especializados (CIAME)
state: Quintana Roo
city: Veracruz
country: Mexico
facility: FAICIC
state: Veracrua
city: Mérida
country: Mexico
facility: Kohler & Milstein Research
state: Yucatan
city: Ciudad de mexico
country: Mexico
facility: PEMEX
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Pediatría (INP)
city: Durango
country: Mexico
facility: Instituto de Investigaciones aplicada a las Neurociencias (IIAN)
city: Puebla
country: Mexico
facility: Administración de Especialistas de Puebla S.C. (UDEP)
city: Islamabad
country: Pakistan
facility: Shifa International Hospital
state: Islamabad Capital Territory
city: Lahore
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital and Research Centre
state: Punajb
city: Lahore
country: Pakistan
facility: University of Health Scinces, Lahore
state: Punjab
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: The Indus Hospital
state: Sindh
city: Saint Petersburg
country: Russian Federation
facility: Research Center Eco-safety
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: OOO Meditsinskie Tekhnologii
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: OOO "Baltijskaya Meditsina"
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: Research Center Eco-safety
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: 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
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: OOO "Piterclinica"
state: Saint-Petersburg
city: Aramil
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"
state: Sverdlovsk
city: Chelyabinsk
country: Russian Federation
facility: Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"
city: Chita
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation
city: Moscow
country: Russian Federation
facility: Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"
city: Moscow
country: Russian Federation
facility: Health Central Clinical Hospital of Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: 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)
city: Moscow
country: Russian Federation
facility: Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"
city: Murmansk
country: Russian Federation
facility: State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin"
city: Murmansk
country: Russian Federation
facility: State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital"
city: Nizhniy Novgorod
country: Russian Federation
facility: Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"
city: Novosibirsk
country: Russian Federation
facility: "Life Benefits Service, Ltd'
city: Omsk
country: Russian Federation
facility: Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."
city: Perm
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: OOO Zvyezdnaya Klinika
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "Hospital "OrKli"
city: Saratov
country: Russian Federation
facility: OOO "Tsentr DNK issledivaniy"
city: Saratov
country: Russian Federation
facility: 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
city: Tomsk
country: Russian Federation
facility: OOO "Zdorovye"
city: Yaroslavl
country: Russian Federation
facility: State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"
Study officials:
affiliation: Canadian Center for Vaccinology
name: Scott A Halperin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
name: Fengcai Zhu
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Center for Vaccinology
name: Joanne M angley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.