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

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Biological: Placebo; Biological: Gam-COVID-Vac

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-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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo
Experimental: Vaccine Gam-COVID-Vac; Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2 infection	Biological: Gam-COVID-Vac; Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization with component I (rAd26-S) and component II (rAd5-S) with 21 days interval; Other Names: Sputnik V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate	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	42 day, 180 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events	Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo	through the study (till day 180)
Virus-neutralizing antibody levels against the SARS-CoV-2	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	42 day
Antibody levels against the SARS-CoV-2 glycoprotein	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	42 day, 180 day
Percentage of trial subjects with coronavirus disease 2019 (COVID-19)	Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)	through the study (till day 180)

Collaborators and Investigators

• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Collaborators: 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"

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; COVID-19; Ad5; adenoviral vector; Ad26; Heterologous prime-boost vaccination
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 01V-Gam-COVID-Vac-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No