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COVID-19Phase 3NCT04526990

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

A Phase 3 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with COVID-19, run by CanSino Biologics Inc. at 74 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44,247 participants
Where
74 sitesin 5 countries
Study dates
15 Sep 2020to 21 Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

74 sites in 5 countries.

74 sites in 5 countries

Russia28 sites

  • State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"

    Aramil, Sverdlovsk Oblast, 624002

  • Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"

    Chelyabinsk, 454000

  • State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation

    Chita, 672000

  • Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation

    Moscow, 105229

  • Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"

    Moscow, 117556

  • Health Central Clinical Hospital of Russian Academy of Sciences

    Moscow, 117593

  • 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, 119435

  • Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"

    Moscow

  • State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin"

    Murmansk, 183047

  • State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital"

    Murmansk

  • Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"

    Nizhny Novgorod, 603140

  • "Life Benefits Service, Ltd'

    Novosibirsk, 630091

  • Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."

    Omsk, 644112

  • Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation

    Perm, 614070

  • Research Center Eco-safety

    Saint Petersburg, Sankt-Peterburg, 191119

  • OOO Meditsinskie Tekhnologii

    Saint Petersburg, Sankt-Peterburg, 192148

  • OOO "Baltijskaya Meditsina"

    Saint Petersburg, Sankt-Peterburg, 194356

  • Research Center Eco-safety

    Saint Petersburg, Sankt-Peterburg, 196143

  • 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, Sankt-Peterburg, 197376

  • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"

    Saint Petersburg, Sankt-Peterburg, 198328

  • Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"

    Saint Petersburg, Sankt-Peterburg, 198510

  • OOO "Piterclinica"

    Saint Petersburg, Sankt-Peterburg

  • OOO Zvyezdnaya Klinika

    Saint Petersburg, 196158

  • Limited Liability Company "Hospital "OrKli"

    Saint Petersburg, 199178

  • OOO "Tsentr DNK issledivaniy"

    Saratov, 410005

  • 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, 410054

  • OOO "Zdorovye"

    Tomsk

  • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"

    Yaroslavl, 150003

Other trials in Russia

Mexico22 sites

  • Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)

    Acapulco de Juárez, Guerrero, 39670

  • Centro de investigación Médica Aguascalientes (CIMA)

    Aguascalientes, Aguascalientes, 999085

  • Centro de Investigación y Avances Médicos Especializados (CIAME)

    Cancún, Quintana Roo, 999085

  • Centro de Investigacion Integral MEDIVEST SC

    Chihuahua City, Chhihuahia, 31203

  • Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)

    Coyoacán, Mexico City, 04100

  • Instituto Mexicano del Seguro Social (IMSS)

    Cuahtemoc, Mexico City

  • JM Research

    Cuernavaca, Morelos, 62290

  • Instituto de Investigaciones aplicada a las Neurociencias (IIAN)

    Durango, 34000

  • Instituto Jaliscience de Metabolismo, S. C.

    Guadalajara, Jalisco, 44670

  • Kohler & Milstein Research

    Mérida, Yucatán, 97070

  • Instituto de Servicios de Salud del Estado de Baja California

    Mexicali, Baja California Norte

  • Instituto Nacional de Pediatría (INP)

    Mexico City, 04530

  • PEMEX

    Mexico City

  • Asociación de investigación pediátrica y adultos (AINPAD)

    Morelia, Mochoacán de Ocampo, 58350

  • Oaxaca site management organization (OSMO)

    Oaxaca City, Oaxaca, 68000

  • Asociación Mexicana para la investigación clínica (AMIC)

    Pachuca, Hidalgo, 42070

  • Administración de Especialistas de Puebla S.C. (UDEP)

    Puebla City, 72160

  • Clinical Research Institute Saltillo SA de CV

    Saltillo, Cuahuila, 25020

  • Hospital Metropolitano "Dr. Bernardo Sepúlveda"

    San Nicolás de los Garza, Nuevo León, 66480

  • Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)

    Tlalpan, Mexico City, 14080

  • Instituto Nacional de Medicina Genómica

    Tlalpan, Mexico City

  • FAICIC

    Veracruz, Veracrua, 91900

Other trials in Mexico

Argentina12 sites

  • Fundación Socolinsky Centro de Vacunación Proteger - Recoleta

    CABA, Buenos Aires, C1023AAO

  • Hospital Pirovano

    CABA, Buenos Aires, C1430BKC

  • Htal de Alta Complejidad Cuenca Alta Néstor Kirchner

    Canuelas, Buenos Aires, 1814

  • Previvax Centro de Vacunación

    Córdoba, 5000

  • Hospital Interzonal de Agudos "San Juan de Dios" de La Plata

    La Plata, Buenos Aires, 1900

  • Hospital Rossi

    La Plata, Buenos Aires, 1900

  • Inst. Médico Platense

    La Plata, Buenos Aires, 1900

  • Instituto de Investigaciones Clínicas

    Mar del Plata, Buenos Aires, 7600

  • Htal Mariano y Luciano de la Vega

    Moreno, Buenos Aires, 1744

  • Hospital Houssay

    Vicente López, Buenos Aires, 999071

  • Hospital Zonal General de Agudos "Cetrangolo"

    Vicente López, Buenos Aires, 999071

  • Instituto Cer

    Vicente López, Quilmes, 1878

Other trials in Argentina

Chile7 sites

  • Clínica Andes Salud Concepción

    Concepción, Maule Region, 4030000

  • Hospital Base de Osorno

    Osorno, Los Ríos Region, 5290000

  • Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt

    Port Montt, X Región de Los Lagos, 5480000

  • CIMER Centro de Investigaciones Medicas Respiratorias Santiago

    Providencia, Santiago Metropolitan, 7500000

  • Hospital San Borja Arriarán Santiago

    Santiago, Santiago Metropolitan, 8320000

  • Hospital Dr. Hernan Henriquez Aravena Temuco

    Temuco, Araucania, 4780000

  • Clinica Alemana de Valdivia Valdivia

    Valdivia, Los Ríos Region, 5090000

Other trials in Chile

Pakistan5 sites

  • Shifa International Hospital

    Islamabad, Islamabad, 30001

  • Aga Khan University Hospital

    Karachi, Sindh, 999010

  • The Indus Hospital

    Karachi, Sindh, 999010

  • Shaukat Khanum Memorial Cancer Hospital and Research Centre

    Lahore, Punajb, 54000

  • University of Health Scinces, Lahore

    Lahore, Punjab Province, 999010

Other trials in Pakistan

About this study

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

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.

Read the 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).

Conditions
COVID-19
Being tested
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Placebo
Keywords
COVID-19, vaccine, Ad5, Safety, Immunogencity, efficacy, adaptive design, SARS-CoV-2, Adenovirus Vector
Medical subject headings
COVID-19, Alzheimer Disease 5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Biological

    Intramuscular administration

  • PlaceboBiological

    Intramuscular administration

Study groups in NCT04526990
Study groupRoleWhat they receive
Experimental groupExperimental20000 participants, Ad5-nCoV , single dose, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Placebo groupPlacebo comparator20000 participants, placebo, single dose, Intramuscular administration
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of COVID-19 cases

    The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease

    Measured: day 28 to 12 months post vaccination

  2. Incidence of SAE

    Evaluate the incidence of severe adverse events (SAE)

    Measured: Within 12 months

Secondary outcomes (6)

  1. Incidence of severe COVID-19 cases

    Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection

    Measured: Day 14 to 12 months post vaccination

  2. Incidence of solicited adverse reactions

    Incidence of solicited adverse reactions within 7 days after vaccination, in a subset

    Measured: Day 0-7 post vaccination

  3. Incidence of unsolicited adverse events

    Incidence of unsolicited adverse events within 28 days after vaccination in a subset

    Measured: Day 0-28 post vaccination

  4. Immunogencity of S-RBD IgG antibody (ELISA method)

    The seroconversion rate of S-RBD IgG antibody post vaccination

    Measured: Day 28 post vaccination

  5. Immunogencity of neutralizing antibody

    The seroconversion rate of neutralizing antibody

    Measured: Day 28 post vaccination

  6. Cell-mediated immune profile

    Number of cell-mediated immune response against SARS-CoV-2

    Measured: Day 28 post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2020
  2. Study start15 Sep 2020
  3. Primary completion7 Aug 2021
  4. Study completion21 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44,247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04526990
Sponsor's protocol ID
CS-CTP-AD5NCOV-Ⅲ
Status last verified
Sep 2022
First submitted
22 Aug 2020
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rooyakkers A, Ye L, Cahn PE, Ruiz-Palacios GM, Ikram A, Lanas F, Navarro SRM, Sued O, Lioznov DA, Dzutseva V, Parveen G, Zubkova T, Li J, Langley JM, Wang R, Barreto L, Gou J, Zhu T, Whittle CA, Halperin SA; CanSino COVID-19 Global Efficacy Study Group. Relative efficacy, safety, and immunogenicity analysis of two doses versus one dose of recombinant coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomized, double blinded phase 3 trial. Vaccine. 2026 Apr 19;79:128424. doi: 10.1016/j.vaccine.2026.128424. Epub 2026 Mar 19.

    PubMed 41863180

  • Ruiz-Palacios GM, Cahn PE, Halperin SA, Wang R, Wang L, Perez C, Figueroa MI, Yan M, Li R, Ye L, Huang H, Barreto L, Gou J, Zhu T. Adenovirus type 5 vector-based COVID-19 vaccine does not increase the likelihood of HIV infection. Vaccine. 2026 Apr 11;78:128378. doi: 10.1016/j.vaccine.2026.128378. Epub 2026 Mar 4.

    PubMed 41785679

  • 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.

    PubMed 34953526

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with COVID-19, run by CanSino Biologics Inc. at 74 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Russia, Mexico, Argentina, Chile, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of COVID-19 cases (time frame: day 28 to 12 months post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04526990, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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