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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Biological: Gam-COVID-Vac
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent of a subject to participate in the trial Males and females aged 18+ Negative HIV, hepatitis, and syphilis test results A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay A negative test result for COVID-2019 by PCR at screening visit No COVID-2019 in the medical history No contact with COVID-2019 persons within at least 14 days before the enrollment (according to trial subjects) Consent to use effective contraception methods during the trial Negative urine pregnancy test at the screening visit (for child-bearing age women) Negative drugs or psychostimulants urine test at the screening visit Negative alcohol test at the screening visit No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history No acute infectious and/or respiratory diseases within at least 14 days before the enrollment. Exclusion Criteria: Any vaccination/immunization within 30 days before the enrollment; Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment. Immunosuppressors therapy finished within 3 months before the enrollment Pregnancy or breast-feeding Acute coronary syndrome or stroke suffered less than one year before the enrollment Tuberculosis, chronic systemic infections 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 Neoplasms in the medical history. Donated blood or plasma (450+ ml) within 2 months before the enrollment Splenectomy in the medical history 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 Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C Anorexia, protein deficiency of any origin Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration Alcohol or drug addiction in the medical history Participation in any other interventional clinical trial. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol Study center staff and other employees directly involved in the trial and their families.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine Gam-COVID-Vac<br>Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2 infection | Biological: Gam-COVID-Vac<br>* 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<br>* Other names: Sputnik V;|
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, COVID-19, adenoviral vector, SARS-CoV-2, Ad26, Ad5, Heterologous prime-boost vaccination