Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is aimed to evaluate the safety and immunogenicity of the medicinal product
      "GamTBvac" - a recombinant subunit vaccine against the tuberculosis. The study is designed as
      a comparative placebo-controlled study with a two-fold increase of an applied dose among
      healthy volunteers aged 18-49 years.
    

Detailed description: 
      The clinical trial study of the "GamTBvac" vaccine against the tuberculosis is a comparative
      placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers
      aged 18-49 years. The product "GamTBvac" is a lyophilized substance consisted of the purified
      recombinant subunit antigens of Mycobacterium tuberculosis, that is applied for the preparing
      of the solution for a subcutaneous administration. Currently the study is at the first phase.

      The aims of the study are: a) to confirm the safety of the product in the healthy volunteers;
      b) to select the optimal administration dose; c) to evaluate of the immunogenicity of the
      vaccine; d) to investigate the immune cell memory as a response to the vaccination.

      The total number of the volunteers in the study is 60:

        1. at the first stage to estimate the safety and portable of the vaccine, two groups of
           volunteers each includes 12 persons got the single decreased dose (0.25 of the planned
           dose for regular administration) of the vaccine (the first group, 12 persons), and the
           0.5 ml of the placebo (the second group, 12 persons);

        2. at the second stage to select the optimal dose and the scheme of the vaccine
           administration, additionally three groups, each consist of 12 persons of volunteers will
           be recruited. The first group will get double vaccination of a decreased dose (0.25 of
           the regular dose), the second group will get the double vaccination of a mean dose (0.5
           of the regular dose), and the third one will get the double vaccination of the maximum
           (1.0 regular) dose.

      The inclusion criteria for the volunteers of the study are: healthy males either females aged
      18-49 years who have previously got the BCG vaccine. The exclusion criterion is the presence
      of the latent tuberculosis in the patient that is confirmed during the preliminary laboratory
      screening.
    

Intervention name(s): Single GamTBvac vaccination (0.25 dose); Placebo administration; Double GamTBvac vaccination (0.25 dose); Double GamTBvac vaccination (0.5 dose); Double GamTBvac vaccination (1.0 dose)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.; Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).; Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity.; Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity.; Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The clinical trial study of the "GamTBvac" vaccine against the tuberculosis is a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volonteers aged 18-49 years.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Tuberculosis; Recombinant vaccine; Mycobacterium tuberculosis