Tuberculosis Clinical Trial
— GamTBvacOfficial title:
Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis. Comparative Placebo-controlled Study With a Two-fold Increase of the Vaccine Dose in Healthy Volunteers Aged 18-49 Years.
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 13, 2017 |
Est. primary completion date | December 13, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - lack of the latent tuberculosis, laboratory confirmed - BCG vaccination in the past - signed informed consent Exclusion Criteria: - presence of the latent tuberculosis, laboratory confirmed |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Sechenov First Moscow State Medical University | Moscow |
Lead Sponsor | Collaborator |
---|---|
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation |
Russian Federation,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | immunogenicity control | Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell | 140 Days |
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