Study to evaluate the efficacy of GlaxoSmithKline (GSK) Biologicals’ candidate tuberculosis (TB) vaccine in adults
Trial overview
Incident rates of Definite Pulmonary tuberculosis (TB) disease, not associated with HIV-infection, meeting the case definition 1
Timeframe: From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first
Incident rates of Definite Xpert MTB/Rif positive Pulmonary TB disease, not associated with HIV-infection, meeting the case definition 2
Timeframe: From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first
Incident rates of definite pulmonary TB disease, not associated with HIV-infection meeting the case definition 3
Timeframe: From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first
Incident rates of Microbiological Pulmonary TB disease, meeting the case definition 4
Timeframe: From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first
Incidence rates of Clinical TB disease, meeting the case definition 5
Timeframe: From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first
Number of subjects with serious adverse events (SAEs).
Timeframe: From Day 0 up to Year 3 (during the entire study period)
Number of subjects with any unsolicited adverse events (AEs).
Timeframe: During the 30-day follow-up period following vaccination, across doses (i.e. day of vaccination and 29 subsequent days after each vaccine dose)
Number of subjects with any solicited local AEs in the safety and immune sub-cohort
Timeframe: During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose
Number of subjects with any solicited general AEs in the safety and immune sub-cohort
Timeframe: During the 7-day follow-up period (i.e.: day of vaccination and 6 subsequent days) after each vaccine dose
Number of subjects with any potential immune-mediated diseases (pIMDs)
Timeframe: From Day 0 to 6 months post-dose 2 (i.e. at Month 7)
Number of subjects with grade equal or greater than 2 of severity for haematological and biochemichal abnormal laboratory values in the safety and immune sub-cohort
Timeframe: Days 0, 7, 30 and 37
Desciptive statistics of the frequency of M72-specific CD4+ T-cells expressing any combination of immune markers in the safety and immune sub-cohort
Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)
Desciptive statistics of the frequency of M72-specific CD8+ T-cells expressing any combination of immune markers in the safety and immune sub-cohort
Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)
M72-specific antibody concentrations as measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the safety and immune sub-cohort
Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)
Number of seropositive subjects for M72 antibodies measured by ELISA in the safety and immune sub-cohort
Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)
Participation criteria
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent.
- Current TB disease or history of TB disease and/or treatment for TB.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent.
- Written (or thumb printed and witnessed) informed consent obtained from the subject.
- Baseline positive IGRA test result.
- Baseline negative HIV screen.
- Baseline negative clinical screening questionnaire and negative sputum sample for Pulmonary TB disease.
- Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination.
- 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 25 days prior to vaccination, and
- has a negative pregnancy test on the day of screening and the day of first vaccination, and
- has agreed to continue adequate contraception during the entire vaccination period and for 2 months after completion of the vaccination series.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each dose of vaccine.
- History of previous administration of experimental Mtb vaccines.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- Any condition or illness or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Planned participation or participation in another experimental protocol during the study.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- History of medically confirmed autoimmune disease.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination period and/or before 2 months after completion of the vaccination series.
Current TB disease or history of TB disease and/or treatment for TB.
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.