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Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela
(VENEZUELA)

[Link] Identifier: NCT04642339

The safety and scientific validity of this study is the

Recruitment Status  : Not yet recruiting
responsibility of the study sponsor and investigators.
First Posted  : November 24, 2020
Listing a study does not mean it has been evaluated
Last Update Posted  : November 24, 2020
by the U.S. Federal Government. Know the risks and
potential benefits of clinical studies and talk to your See Contacts and Locations

health care provider before participating. Read our

disclaimer for details.

Sponsor:

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 Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Collaborator:
Ministerio del Poder Popular para la Salud de la República Bolivariana de Venezuela

Information provided by (Responsible Party):

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record

Study Description Go to

Brief Summary:
Randomized, double-blind, placebo controlled clinical trial of immunogenicity, safety and efficacy of the Gam-COVID-Vac combined vector vaccine against the
SARS-CoV-2-induced coronavirus infection in adults.

Condition or disease  Intervention/treatment  Phase 

Covid19 Biological: Gam-COVID-Vac Phase 3

Biological: Placebo

Detailed Description:

Randomized, double-blind (blinded for trial subject and the study physician), placebo controlled clinical trial in parallel assignment of the
immunogenicity, safety, and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in
adults.

The trial will include 2,000 volunteers over the age of 18. After screening, they will be randomised (3:1) into two groups - a reference group of 500
volunteers who will receive the placebo and a study group of 1,500 volunteers who will receive the combined Gam-COVID-Vac vaccine against SARS-

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 induced coronavirus infection-СoV-2oV-2. The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60 and 60+ years. Each
subject will participate in the trial for 180±14 days after the first dose of the study drug/placebo and will have one screening visit and five on-site visits
to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 1 and
day 21±2). Follow-up visits Nos. 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14, respectively. Blood samples will be taken from certain
subjects during the following visits to assess the immunogenicity parameters on days 1, 42±2 and 180±14. During observation visits, vital indicators
will be assessed on all trial subjects and changes in the subjects' condition and well-being will be recorded, observational visits may be remote, using
telemedicine (TM) technologies. Additionally, the trial subjects will be able to have remote consultations with the study physician through the TM. Data
from trial subjects will be collected through electronic case report forms.

Study Design Go to

Study Type  : Interventional (Clinical Trial)

Estimated Enrollment  : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Placebo Controlled, Clinical Trial of the Immunogenicity, Safety, and Efficacy of the
Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection
Estimated Study Start Date  : November 2020
Estimated Primary Completion Date  : October 2021
Estimated Study Completion Date  : December 2021

Arms and Interventions Go to

Arm  Intervention/treatment 

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 Arm  Intervention/treatment 

Experimental: Vaccine Gam-COVID-Vac Biological: Gam-COVID-Vac

Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2 Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose
infection prime-boost immunization with component I (rAd26-S) and
component II (rAd5-S) with 21 days interval
Other Name: Sputnik V

Placebo Comparator: Placebo Biological: Placebo

Placebo Placebo

Outcome Measures Go to

Primary Outcome Measures  :

1. Seroconversion rate [ Time Frame: 42 day, 180 day ]

Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on
the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

Secondary Outcome Measures  :

1. Incidence and severity of adverse events [ Time Frame: through the study (till day 180) ]

Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo

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 2. Virus-neutralizing antibody levels against the SARS-CoV-2 [ Time Frame: 42 day ]

Geometric mean virus-neutralizing antibodies titer in 500 trial subjects on the drug administration day before injecting the first dose of the
study drug/placebo and 42±2 days after the first dose

3. Antibody levels against the SARS-CoV-2 glycoprotein [ Time Frame: 42 day, 180 day ]

Geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before
injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

4. Percentage of trial subjects with coronavirus disease 2019 (COVID-19) [ Time Frame: through the study (till day 180) ]

Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of
polymerase chain reaction (PCR)

Eligibility Criteria Go to

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or
friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study
research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All

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 Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Written informed consent of a subject to participate in the trial

2. Males and females aged 18+

3. Negative HIV, hepatitis, and syphilis test results

4. A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay

5. A negative test result for COVID-2019 by PCR at screening visit

6. No COVID-2019 in the medical history

7. No contact with COVID-2019 persons within at least 14 days before the enrollment (according to trial subjects)

8. Consent to use effective contraception methods during the trial

9. Negative urine pregnancy test at the screening visit (for child-bearing age women)

10. Negative drugs or psychostimulants urine test at the screening visit

11. Negative alcohol test at the screening visit

12. No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history

13. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.

Exclusion Criteria:

1. Any vaccination/immunization within 30 days before the enrollment;

2. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
3. Immunosuppressors therapy finished within 3 months before the enrollment

4. Pregnancy or breast-feeding
5. Acute coronary syndrome or stroke suffered less than one year before the enrollment

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 6. Tuberculosis, chronic systemic infections

7. Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction
to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment
day
8. Neoplasms in the medical history.

9. Donated blood or plasma (450+ ml) within 2 months before the enrollment
10. Splenectomy in the medical history

11. Neutropenia (absolute neutrophil count <1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L),
immunodeficiency in the medical history within 6 months before the enrollment

12. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
13. Anorexia, protein deficiency of any origin

14. Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo
administration
15. Alcohol or drug addiction in the medical history

16. Participation in any other interventional clinical trial.

17. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
18. Study center staff and other employees directly involved in the trial and their families.

Contacts and Locations Go to

Information from the National Library of Medicine

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 To learn more about this study, you or your doctor may contact the study research staff using the contact information
provided by the sponsor.

Please refer to this study by its [Link] identifier (NCT number): NCT04642339

Contacts

Contact: Alexis H García Piñero, MD +582122191711 alexisgarcia27@[Link]

Contact: Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa" +582122191711 presidencia@[Link]

Sponsors and Collaborators

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Ministerio del Poder Popular para la Salud de la República Bolivariana de Venezuela

Investigators

Principal Investigator: Alexis H García Piñero, MD Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa"

More Information Go to

Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
[Link] Identifier: NCT04642339 History of Changes
Other Study ID Numbers: 01V-Gam-COVID-Vac-2020
First Posted: November 24, 2020 Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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 Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
vaccine Ad26
COVID-19 Ad5
adenoviral vector Heterologous prime-boost vaccination
SARS-CoV-2

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