A Phase 1 interventional study of Single GamTBvac vaccination (0.25 dose) and Placebo administration in Tuberculosis, sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-27.
Sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Phase 1, Interventional, and Prevention
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.
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:
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.
Exclusion Criteria:
12 persons who have got a single decreased dose (0.25 of the planned dose for regular administration) of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: single GamTBvac vaccination (0.25 dose).
Biological: Single GamTBvac vaccination (0.25 dose)
12 persons who have got a single dose of placebo (0.5 ml). The intervention for the Arm: Placebo administration (0.5 ml)
Biological: Placebo administration
12 persons who will get a double sequential administration of the decreased dose (0.25 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: double GamTBvac vaccination (0.25 dose).
Biological: Double GamTBvac vaccination (0.25 dose)
12 persons who will get a double sequential administration of the mean dose (0.5 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: double GamTBvac vaccination (0.5 dose).
Biological: Double GamTBvac vaccination (0.5 dose)
12 persons who will get a double sequential administration of the maximum (regular) dose of the GamTBvac recombinant subunit vaccine. The intervention for the Arm: double GamTBvac vaccination (1.0 dose).
Biological: Double GamTBvac vaccination (1.0 dose)
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.
The number and severity of adverse effects
Safety control: an active periodical examination of the health status of volunteers, including vital indicators, instrumental tests (ECG), laboratory blood and urine analysis (general and biochemistry). The presence, nature and severity of local and systemic reactions in different groups of volunteers, depending on the dose of vaccination, will be taken into account.
Time frame: 140 Days
immunogenicity control
Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell
Time frame: 140 Days
Plan to share: No
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation