Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

December 1, 2018

Primary Completion Date

December 31, 2019

Study Completion Date

May 31, 2020

Conditions
Healthy
Interventions
BIOLOGICAL

GamTBvac vaccine

introduction of GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose) twice into a shoulder with an 8-week interval.

BIOLOGICAL

placebo

introduction of placebo twice into a shoulder with an 8-week interval.

Trial Locations (2)

117556

"City polyclinic № 2 Of the Department of health of the city of Moscow, Выделите текст, чтобы посмотреть примеры", Moscow

119991

Sechenov University, Moscow

All Listed Sponsors
collaborator

contract research organization Cromos Pharma

UNKNOWN

collaborator

contract research organization K-Research

UNKNOWN

lead

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

OTHER

NCT03878004 - Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac | Biotech Hunter | Biotech Hunter