An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" 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 this study: to evaluate the safety, tolerability and immunogenicity of the
      drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular
      administration, at various times after vaccination in healthy adult volunteers.
    

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 Lyo", lyophilisate for the preparation of a solution for intramuscular
      administration, with the participation of healthy volunteers.

      Study objectives

        1. A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for
           the preparation of a solution for intramuscular administration, using single dose of
           each component (Stage 1).

        2. A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for
           the preparation of a solution for intramuscular administration, using prime-boost
           immunization according to the proposed scheme (Stage 2).

      Study Design Stage 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.

      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.

      Throughout the inpatient observation and the follow-up period (180 days) of visits during the
      entire study, safety information will be collected
    

Intervention name(s): Gam-COVID-Vac Lyo
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; adenovirus vector