Status:
COMPLETED
Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.
Lead Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions:
Tuberculosis
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief 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 placeb...
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 ye...
Eligibility Criteria
Inclusion
- lack of the latent tuberculosis, laboratory confirmed
- BCG vaccination in the past
- signed informed consent
Exclusion
- presence of the latent tuberculosis, laboratory confirmed
Key Trial Info
Start Date :
January 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03255278
Start Date
January 15 2017
End Date
December 13 2017
Last Update
December 27 2017
Active Locations (1)
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1
Sechenov First Moscow State Medical University
Moscow, Russia, 119435