"Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine GamTBvac Against the Tuberculosis."

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 15, 2017

Primary Completion Date

December 13, 2017

Study Completion Date

December 13, 2017

Conditions
Tuberculosis
Interventions
BIOLOGICAL

Single GamTBvac vaccination (0.25 dose)

Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.

BIOLOGICAL

Placebo administration

Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).

BIOLOGICAL

Double GamTBvac vaccination (0.25 dose)

Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity.

BIOLOGICAL

Double GamTBvac vaccination (0.5 dose)

Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity.

BIOLOGICAL

Double GamTBvac vaccination (1.0 dose)

Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.

Trial Locations (1)

119435

Sechenov First Moscow State Medical University, Moscow

All Listed Sponsors
lead

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

OTHER

NCT03255278 - "Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine GamTBvac Against the Tuberculosis." | Biotech Hunter | Biotech Hunter