An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" Vaccine Against COVID-19
Condition: Preventive Immunization COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to assess safety, tolerability and immunogenicity of the drug
      "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of
      healthy volunteers

      Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution
      for intramuscular administration, using single dose of each component (Stage 1).

      A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular
      administration, using prime-boost immunization according to the proposed scheme (Stage 2).

      Post-vaccination immunity assessment at different time points after vaccination by:

        -  Determination of antigen-specific antibody titer in blood serum by ELISA by comparison
           with baseline values before the vaccine administration and at days 14, 21, 28, and 42
           after vaccination (hereinafter, the countdown comes from the first time of the vaccine
           administration);

        -  Determination of virus neutralizing antibody titer before and at days 14, 28, and 42
           after vaccination;

        -  Determination of antigen-specific cellular immunity (specific T-cell immunity) before
           the vaccine administration and at days 14 and 28 after vaccination.
    

Detailed description: 
      An open two stage non-randomized Phase 1 study with the participation of healthy volunteers.
      This clinical trial is an open study of safety, tolerability and immunogenicity of the drug
      "Gam-COVID-Vac ", ly solution for intramuscular administration, with the participation of
      healthy volunteers.

      Stage one

        1. the First group, 9 volunteers, will receive the drug, a solution for intramuscular
           administration, in the mode of single immunization with component 1 in a full
           therapeutic dose.

        2. the Second group, 9 volunteers, will receive the drug, a solution for intramuscular
           administration, in the mode of single immunization with component 2 in the full
           therapeutic dose.

      The studied drugs will be administered to a total of 18 volunteers in a hospital setting and
      after administration, the drug's safety will be continuously monitored for 5 days. Based on
      the results of the safety assessment, the Chief investigator decides to proceed to the second
      stage of the study on the 5th day after the introduction of the studied drugs.

      Second stage The second stage will include 20 volunteers and three understudies. Volunteers
      of the second stage will be vaccinated no earlier than 5 days after vaccination of
      participants of the first stage.

      Volunteers participating in the second stage of the study (a total of 20 people) will receive
      the study drug according to the booster scheme: the introduction of component 1 will be
      carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried
      out during 4 visits: on 7, 14, 28, 42 days after administration of the drug, and phone calls
      at days 90 and 180

      Throughout the inpatient observation and the follow-up period of visits during the entire
      study, safety information will be collected
    

Intervention name(s): Gam-COVID-Vac
Intervention type(s): Biological
Intervention description(s): adenoviral-based vaccine against SARS-CoV-2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19; SARS-CoV-2; vector vaccine