Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac in Preventing the Development of Respiratory Tuberculosis Not Associated With HIV Infection in Volunteers Aged 18-45 Years
This is a multicenter, double-blind, randomized (in 1:1 ratio) placebo-controlled study to assess the safety and protective efficacy of the subunit recombinant tuberculosis vaccine GamTBvac against the development of respiratory tuberculosis not associated with HIV infection in volunteers aged 18-45 years.
• Male and female volunteers aged 18-45 years (inclusive);
• Volunteers from population groups with a high incidence of tuberculosis (more than 30 people per 100 thousand population);
• Absence of active tuberculosis, confirmed by chest x-ray or computed tomography;
• Body mass index 18.5 - 30 kg / m2 (inclusive) according to Quetelet's weight and height index;
• Signed informed consent to participate in the study in accordance with the current legislation;
• Previous bacille Calmette Guerin (BCG) vaccination according to medical history or confirmed by the presence of a scar;
• Absence of markers of the immune response to mycobacterial proteins ESAT6 and CFP10, which characterize the probable contact with M. tuberculosis prior to the start of the study confirmed by the tuberculosis skin test;
• Negative pregnancy test in female volunteers with preserved reproductive potential at screening and on the day of the first vaccination;
• Consent of male and female participants with preserved reproductive potential to observe an adequate method of contraception (double barrier method: male or female condom and combined hormonal contraceptive (oral, vaginal and transdermal forms can be used) or using a condom or diaphragm with spermicide during the entire period of vaccination and 1 month after completion of vaccination Exception: surgically sterile (more than 6 months) or postmenopausal (more than 12 months);
⁃ Consent of male participants not to participate in sperm donation during the entire period of vaccination and 1 month after completion of vaccination.