TuberculosisPhase 3NCT04975737
Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac
A Phase 3 study testing GamTBvac in people with Tuberculosis, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- GamTBvac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,500 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jan 2022to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Body mass index (BMI) 18.5 - 30 kg/m² (inclusive), calculated as weight/height² (Quetelet index).
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- 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.
- For volunteers without a history of active pulmonary tuberculosis: negative immune response markers to mycobacterial proteins ESAT 6 and CFP 10 (indicating no prior probable contact with M. tuberculosis before study entry), as assessed by Diaskintest® and Mantoux test. For volunteers with a history of active respiratory tuberculosis that has resolved with cure and no residual or only minor residual changes without aggravating factors, and who are under Group III dispensary follow up at the time of enrollment, testing for ESAT 6/CFP 10 immune markers is not an inclusion/exclusion criterion.
- Negative pregnancy test for female volunteers of childbearing potential at screening and on the day of first vaccination.
- 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).
- Agreement by male participants to refrain from sperm donation throughout the entire vaccination period and for 1 month after the last vaccination.
- According to the Russian tuberculosis clinical classification, Group III dispensary registration applies to individuals cured of tuberculosis who are at low risk of relapse and require regular follow-up monitoring.
- Non-inclusion criteria:
- 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;
- Clinically significant ECG abnormalities at screening;
- History of significant allergic conditions (bronchial asthma, history of anaphylactic reactions);
- Hypersensitivity to any component of the investigational product or placebo; history of drug intolerance;
- Presence of any disease or use of any medication that, in the investigator's opinion, may interfere with the assessment of vaccine safety or efficacy;
- History or physical/laboratory findings suggestive of any possible immunodeficiency condition;
- History of any autoimmune disease (including systemic lupus erythematosus, type 1 diabetes mellitus, etc.);
- Regular use (for more than 2 weeks) of immunosuppressants or other immunomodulating drugs within 6 months prior to the study enrollment (with the exception of inhaled or topical corticosteroids);
- Use of immunoglobulin or blood products within 3 months prior to or planned use during the study enrollment;
- Use of antibacterial (including anti-tuberculosis) drugs within 14 days prior to vaccination orally and/or within 28 days prior to vaccination (parenterally);
- Pregnancy, breastfeeding, refusal to use a double-barrier method of contraception, participation of a woman in an oocyte donation program;
- Inability of the volunteer to understand the objectives, goals, and design of the study; known inability to comply with the protocol-specified plan, visit schedule, and procedures;
- Participation in clinical trials of medicinal products within 3 months prior to the study enrollment, or planned participation in another clinical trial;
- Previous receipt of the GamTBvac vaccine and/or participation in clinical trials of any experimental anti-tuberculosis vaccines;
- Any vaccination or planned vaccination within less than one month prior to the first vaccination in this study or within one month after each vaccination in this study;
- Confirmed history of alcoholism, drug addiction, or substance abuse;
- Positive urine drug test for narcotic and psychotropic substances;
- Positive ethanol test (in exhaled breath)/using saliva test strips.
Who cannot join
- Participation of a volunteer in the study may be terminated for the following reasons:
- Development of tuberculosis of any localization, including respiratory tuberculosis, or recurrence of respiratory tuberculosis.
- The investigator determines that the volunteer should be withdrawn in the volunteer's best interest.
- Occurrence of a serious adverse event (SAE) related to the investigational vaccine.
- Non-compliance by the volunteer with the study participation requirements.
- Retusal to cooperate or non-compliance by the participant.
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- Enrollment of the participant in violation of the protocol's inclusion/non-inclusion criteria.
- Development of any other significant adverse events.
- Deterioration of the volunteer's health status.
- Initiation of another investigational product by the volunteer.
- Major protocol violations that may affect the volunteer's safety or the integrity of the study data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of the GamTBvac Recombinant Subunit Tuberculosis Vaccine for the Prevention of Non-HIV-associated Pulmonary Tuberculosis in Volunteers Aged 18 Years and Older.
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.
Read more
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.
- Conditions
- Tuberculosis
- Being tested
- GamTBvac, Placebo
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamTBvacBiological
The subunit recombinant tuberculosis vaccine GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose)
PlaceboBiological
Placebo for subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Group (Stage 1) | Experimental | 177 volunteers will be receiving GamTBvac. Subcutaneous administration of the vaccine will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each vaccination, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). Receives: Biological: GamTBvac |
| Placebo group (Stage 1) | Placebo comparator | 177 volunteers will be receiving placebo. Subcutaneous administration of the placebo will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each administration, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). Receives: Biological: Placebo |
| Vaccine Group (Stage 2) | Experimental | 1073 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 receiving GamTBvac. Subcutaneous administration of GamTBvac will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. Participants will be observed for 5 hours after each vaccination. Follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. Receives: Biological: GamTBvac |
| Placebo group (Stage 2) | Placebo comparator | 1073 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 receiving placebo. Subcutaneous administration of placebo will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. Participants will be observed for 5 hours after each administration. Follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. Receives: Biological: Placebo |
| Vaccine Group (Stage 3) | Experimental | 3500 volunteers with no history of active pulmonary tuberculosis will be receiving GamTBvac. Subcutaneous administration of the vaccine will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each vaccination, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. Receives: Biological: GamTBvac |
| Placebo group (Stage 3) | Placebo comparator | 3500 volunteers with no history of active pulmonary tuberculosis will be receiving placebo. Subcutaneous administration of the placebo will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each administration, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessment - Stage 1
Efficacy will be assessed in volunteers aged 18 years and older. All study participants will be informed of the potential signs and symptoms indicative of pulmonary tuberculosis and will be instructed to report to the study site promptly should any such symptoms develop, in order to undergo an Unscheduled Visit. For Stage 1, the primary efficacy endpoint will be the incidence rate of respiratory tuberculosis. The diagnosis will be confirmed by the presence of pulmonary foci or infiltrations (physiological parameter) as determined by chest radiography (diagnostic test).
Measured: 24 months after vaccination
Primary endpoint for Stage 2 of the study
The prophylactic efficacy of the GamTBvac vaccine will be assessed by comparing the incidence rate of active pulmonary tuberculosis cases between the study groups during the post-vaccination follow-up period in volunteers with a prior history of active respiratory tuberculosis, at 24 month after the first vaccination.
Measured: 24 months after vaccination
Primary endpoint for Stage 3 of the study
The prophylactic efficacy of the GamTBvac vaccine will be assessed by comparing the incidence rate of active pulmonary tuberculosis cases between the study groups during the post-vaccination follow-up period in volunteers with no prior history of active respiratory tuberculosis, at 24 months after the first vaccination.
Measured: 24 months after vaccination
Safety Endpoint Analysis
Safety analyses will be performed in the safety population (SAF). The number and percentage of volunteers with adverse events (AEs) and serious adverse events (SAEs) will be tabulated by system organ class (SOC) and preferred term (PT) according to the MedDRA dictionary, by relationship to the investigational product.
Measured: 24 months after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start20 Jan 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975737
- Sponsor's protocol ID
- 02-GamTBvac-2020
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of the GamTBvac Recombinant Subunit Tuberculosis Vaccine for the Prevention of Non-HIV-associated Pulmonary Tuberculosis in Volunteers Aged 18 Years and Older.
- ClinicalTrials.gov ID
- NCT04975737
- Acronym / sponsor ID
- 02-GamTBvac-2020
- Conditions
- Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,500 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Vaccine Group (Stage 1) | Experimental | Biological: GamTBvac177 volunteers will be receiving GamTBvac. Subcutaneous administration of the vaccine will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each vaccination, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). |
| Placebo group (Stage 1) | Placebo comparator | Biological: Placebo177 volunteers will be receiving placebo. Subcutaneous administration of the placebo will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each administration, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). |
| Vaccine Group (Stage 2) | Experimental | Biological: GamTBvac1073 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 receiving GamTBvac. Subcutaneous administration of GamTBvac will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. Participants will be observed for 5 hours after each vaccination. Follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. |
| Placebo group (Stage 2) | Placebo comparator | Biological: Placebo1073 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 receiving placebo. Subcutaneous administration of placebo will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. Participants will be observed for 5 hours after each administration. Follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. |
| Vaccine Group (Stage 3) | Experimental | Biological: GamTBvac3500 volunteers with no history of active pulmonary tuberculosis will be receiving GamTBvac. Subcutaneous administration of the vaccine will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each vaccination, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. |
| Placebo group (Stage 3) | Placebo comparator | Biological: Placebo3500 volunteers with no history of active pulmonary tuberculosis will be receiving placebo. Subcutaneous administration of the placebo will be performed at Vaccination Visits No. 1 and No. 3 (Day 1 and Day 57 ± 1) in an outpatient setting. After each administration, participants will be observed for 5 hours. Subsequent follow-up visits are planned as follows: Visit 2 (Day 7 ± 1), Visit 4 (Day 64 ± 1), Visit 5 (12 months ± 14 days), and Visit 6 (24 months ± 30 days). In addition, between Visit 5 and Visit 6, the investigator will contact participants by telephone once every 3 months (± 14 days) to assess their well-being and to record adverse events and concomitant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- 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.
Key exclusion criteria (11 listed)
- Development of tuberculosis of any localization, including respiratory tuberculosis, or recurrence of respiratory tuberculosis.
- The investigator determines that the volunteer should be withdrawn in the volunteer's best interest.
- Occurrence of a serious adverse event (SAE) related to the investigational vaccine.
- Non-compliance by the volunteer with the study participation requirements.
- Retusal to cooperate or non-compliance by the participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GamTBvacThe subunit recombinant tuberculosis vaccine GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose) | Biological | Vaccine Group (Stage 1), Vaccine Group (Stage 2), Vaccine Group (Stage 3) |
| PlaceboPlacebo for subcutaneous administration | Biological | Placebo group (Stage 1), Placebo group (Stage 2), Placebo group (Stage 3) |
Primary outcome
Efficacy assessment - Stage 1
Time frame: 24 months after vaccination
Efficacy will be assessed in volunteers aged 18 years and older. All study participants will be informed of the potential signs and symptoms indicative of pulmonary tuberculosis and will be instructed to report to the study site promptly should any such symptoms develop, in order to undergo an Unscheduled Visit. For Stage 1, the primary efficacy endpoint will be the incidence rate of respiratory tuberculosis. The diagnosis will be confirmed by the presence of pulmonary foci or infiltrations (physiological parameter) as determined by chest radiography (diagnostic test).
Primary endpoint for Stage 2 of the study
Time frame: 24 months after vaccination
The prophylactic efficacy of the GamTBvac vaccine will be assessed by comparing the incidence rate of active pulmonary tuberculosis cases between the study groups during the post-vaccination follow-up period in volunteers with a prior history of active respiratory tuberculosis, at 24 month after the first vaccination.
Primary endpoint for Stage 3 of the study
Time frame: 24 months after vaccination
The prophylactic efficacy of the GamTBvac vaccine will be assessed by comparing the incidence rate of active pulmonary tuberculosis cases between the study groups during the post-vaccination follow-up period in volunteers with no prior history of active respiratory tuberculosis, at 24 months after the first vaccination.
Safety Endpoint Analysis
Time frame: 24 months after the vaccination
Safety analyses will be performed in the safety population (SAF). The number and percentage of volunteers with adverse events (AEs) and serious adverse events (SAEs) will be tabulated by system organ class (SOC) and preferred term (PT) according to the MedDRA dictionary, by relationship to the investigational product.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GamTBvac in people with Tuberculosis, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessment - Stage 1 (time frame: 24 months after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.