Safety and immunogenicity of a candidate tuberculosis (TB) vaccine in adults with TB disease
Trial overview
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with adverse events (AEs)
Timeframe: During the 30 day (Days 0-29), after vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: Up to day 210
Number of subjects with anti-Mycobacterium tuberculosis fusion protein M72 antibodies
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)
Concentrations of anti-M72 antibodies
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)
Frequency of M72-specific cluster of differentiation 4 (CD4+) T-cells expressing any combination of the different immune markers
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells expressing at least 2 immune markers among 6
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells expressing any combination of cytokines
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells expressing any combination of immune markers
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific expressing any combination of cytokines
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific expressing any combination of immune markers
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells expressing cytokines in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells expressing immune markers in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific expressing cytokines in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific expressing immune markers in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific cluster of differentiation 8 (CD8+) T-cells expressing at least 2 immune markers
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells expressing at least 2 immune markers among 6
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells expressing any combination of immune markers
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells expressing any combination of cytokines
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific expressing any combination of immune markers
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific expressing any combination of cytokines
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells expressing cytokines in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells expressing immune markers in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific expressing cytokines in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific expressing immune markers in any combination
Timeframe: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Participation criteria
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 59 years of age at the time of the first vaccination.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
- A male or female between, and including, 18 and 59 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- Seronegative for HIV- 1 and –2 antibodies.
- No history of or current extrapulmonary tuberculosis TB. Additionally, based on medical history,
- Subjects in the TB-naive cohort must
- have no active pulmonary disease as indicated by chest X-ray.
- have no signs and symptoms of TB.
- Subjects in the TB-treated cohort must
- have a history of successful treatment for pulmonary TB (completed at least 1 year prior to vaccination).
- Subjects in the TB-treatment cohort must
- have documented treatment for pulmonary TB (smear- or culture confirmed) ongoing for 2-4 months prior to vaccination.
Subjects who the investigator believes can and will comply with the requirements of the protocol.
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
have no history of chemoprophylaxis or treatment for TB.
have no active pulmonary disease on chest X-ray.
- Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period, which in the opinion of the investigator could adversely interfere with the vaccine.
- History of previous administration of experimental TB vaccines.
- History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine.
- Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period.
- Planned participation or participation in another experimental protocol during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of chronic alcohol and/or drug abuse.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects.
- Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions during the active phase of the study (from study start till 2 months after dose 2).
- Additionally, for the TB naïve and TB treated cohorts:
- Additionally, for the TB treatment cohort:
- Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests. Individuals with grade 3 levels will be excluded.
- Failure to convert while on anti-TB treatment at the end of the second month of anti-TB therapy.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.