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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety and portable study group | Experimental | 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). |
|
| Placebo safety study group | Placebo Comparator | 12 persons who have got a single dose of placebo (0.5 ml). The intervention for the Arm: Placebo administration (0.5 ml) |
|
| Immunogenicity study group #1 | Experimental | 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). |
|
| Immunogenicity study group #2 | Experimental | 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). |
|
| Immunogenicity study group #3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single GamTBvac vaccination (0.25 dose) | Biological | Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 140 Days |
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity control | Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell | 140 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sechenov First Moscow State Medical University | Moscow | 119435 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28453555 | Background | Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28;12(4):e0176784. doi: 10.1371/journal.pone.0176784. eCollection 2017. |
| Label | URL |
|---|---|
| Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28 | View source |
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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.
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| Experimental |
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). |
|
| Placebo administration | Biological | Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2). |
|
| Double GamTBvac vaccination (0.25 dose) | Biological | Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity. |
|
| Double GamTBvac vaccination (0.5 dose) | Biological | Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity. |
|
| Double GamTBvac vaccination (1.0 dose) | Biological | Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity. |
|
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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