This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19
Condition: Coronavirus Infections; Vaccine
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized, double-blind, placebo controlled, multi-center clinical trials of the
      tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified
      vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R&D IBP RAS", on adult
      volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the
      tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified
      coronavirus vaccine sorbed on adult volunteers aged 18-60.
    

Detailed description: 
      The study is divided into 3 stages. At Stages I and II of the study, a maximum of 300 healthy
      volunteers aged 18 to 60 years should be screened, of which 200 volunteers meeting the
      inclusion criteria and not non-inclusion criteria, should be included and randomized to study
      the tolerability and safety of the vaccine.

      Stage I includes 15 men and women:

      Group 1 - 10 volunteers who will receive the Vaccine twice with an interval of 14 days
      intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.

      Group 2 - 5 volunteers who will receive placebo twice with an interval of 14 days
      intramuscularly at a dose of 0.5 ml with a post-vaccination observation period of 28 days.

      Stage II includes 185 volunteers:

      Group 1 - 140 volunteers who will receive the Vaccine twice with an interval of 14 days
      intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.

      Group 2 - 45 volunteers who received placebo twice with an interval of 14 days
      intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.

      Stage III of the study, a maximum of 300 volunteers should be screened, of which 200
      volunteers, meeting the inclusion criteria and not non-inclusion criteria, should be included
      and randomized to study the safety and immunogenicity of the vaccine.

      Group 3 - 150 volunteers who will receive the vaccine twice with an interval of 14 days
      intramuscularly in a dose of 0.5 ml with a period of post-vaccination observation for 6
      months.

      Group 4 - 50 volunteers who will receive placebo twice with an interval of 14 days
      intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 6 months.
    

Intervention name(s): Vaccine for intramuscular injection; Placebo comparator (without active ingredient) for intramuscular injection
Intervention type(s): Biological; Other
Intervention description(s): Volunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml; Volunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; Coronavirus infections; Vaccine; SARS-Cov-2; Immunobiological medicine