Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac (NCT04975737) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac
Russia9,500 participantsStarted 2022-01-20
Plain-language summary
This study is a multicenter, double-blind, randomized, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of the GamTBvac recombinant subunit tuberculosis vaccine for the prevention of active non-HIV-associated pulmonary tuberculosis.
The study is divided into three stages. A total of 9,500 volunteers are planned to be enrolled in the study.
Stage 1: A total of 354 volunteers with no history of pulmonary tuberculosis will be enrolled. Volunteers will be randomized in a 1:1 ratio into one of two groups receiving either GamTBvac or placebo. Within each group, stratification will be performed according to the presence or absence of a risk factor (smoking). Based on the results of this stage, the safety of the GamTBvac vaccine will be evaluated according to the criteria specified in the study objectives for Stage 1.
Stage 2: A total of 2,146 volunteers with a history of active pulmonary tuberculosis that resulted in cure without residual changes or with minor residual changes, without aggravating factors, and who at the time of participation are registered and under follow-up in Dispensary Group III will be enrolled. Volunteers will be randomized in a 1:1 ratio into one of two groups receiving either GamTBvac or placebo. Based on the results of this stage, the prophylactic efficacy and safety of the GamTBvac vaccine will be evaluated according to the criteria specified in the study objectives for Stage 2.
In the absence of statistically significant data on vaccine efficacy by Visit 6 (24 months ± 30 days), the study will proceed to Stage 3. In the event that statistically significant data on the prophylactic efficacy of GamTBvac are obtained by Visit 6 (24 months ± 30 days), the study will be terminated.
Stage 3: Up to 7,000 volunteers with no history of active pulmonary tuberculosis will be enrolled. Volunteers will be randomized in a 1:1 ratio into one of two groups receiving either GamTBvac or placebo. Within each group, stratification will be performed according to the presence or absence of a risk factor (smoking). Based on the results of this stage, the safety and prophylactic efficacy of the GamTBvac vaccine will be evaluated according to the criteria specified in the study objectives for Stage 3.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female volunteers aged ≥ 18 years.
. Absence of active tuberculosis, confirmed by chest X ray or chest computed tomography (CT), clinical evaluation, and laboratory findings.
. For the purpose of additional safety evaluations of the investigational product in Stage I: no history of active respiratory tuberculosis.
. For the purpose of the primary and secondary efficacy and safety evaluations in Stage II: a history of active respiratory tuberculosis with documented cure, with no residual changes or only minor residual changes without aggravating factors, and the volunteer must have been transferred to and remain under Group III dispensary follow up (clinical Group III\*) for tuberculosis at the time of study enrollment.
. For the purpose of the primary efficacy and safety evaluations in Stage III: no history of active respiratory tuberculosis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy assessment - Stage 1
Timeframe: 24 months after vaccination
2
Primary endpoint for Stage 2 of the study
Timeframe: 24 months after vaccination
3
Primary endpoint for Stage 3 of the study
Timeframe: 24 months after vaccination
4
Safety Endpoint Analysis
Timeframe: 24 months after the vaccination
Trial details
NCT IDNCT04975737
SponsorGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
. Body mass index (BMI) 18.5 - 30 kg/m² (inclusive), calculated as weight/height² (Quetelet index).
. Written informed consent obtained from the volunteer to participate in the study in accordance with applicable laws and regulations.
. Prior BCG vaccination, as documented in the medical records or confirmed by the presence of a BCG scar.
Exclusion criteria
0. Negative pregnancy test for female volunteers of childbearing potential at screening and on the day of first vaccination.
1. Agreement by male participants and female participants of childbearing potential to use adequate contraception (dual barrier method: male or female condom combined with hormonal contraception \[oral, vaginal, or transdermal\], or use of a condom or diaphragm with spermicide) throughout the entire vaccination period and for 1 month after the last vaccination. Exceptions: surgically sterile individuals (for \> 6 months) or postmenopausal individuals (for \> 12 months).
2. Agreement by male participants to refrain from sperm donation throughout the entire vaccination period and for 1 month after the last vaccination.
. Positive test results for HIV-1/2 antibodies, HBsAg, or hepatitis C virus antibodies at screening (results obtained no later than 30 days prior to study enrollment may be used);
. History of extrapulmonary tuberculosis, with the exception of bronchial tuberculosis;
. History of chronic non-infectious respiratory diseases, including idiopathic pulmonary fibrosis (IPF), bronchial asthma, severe or very severe chronic obstructive pulmonary disease (COPD), or pulmonary hypertension;
. Presence of family contact with a tuberculosis patient at the time of the study;
. Incarceration in a penal institution within 24 months prior to study enrollment;