Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
The purpose of this study is to evaluate the protective efficacy of two doses of GSK
 Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy
 will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because
 pulmonary TB occurs frequently in these countries and age range. In addition, the safety and
 immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of
 volunteers.
Case Definitions:

 • First case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
 complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert
 MTB/RIF and/or microbiological culture and confirmed HIV-negative at the time of TB
 diagnosis.

 • Second case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
 complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert
 MTB/RIF and confirmed HIV-negative at the time of TB diagnosis.

 • Third case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
 complex identified from a sputum specimen, taken up to four weeks after initiation of TB
 treatment, by Xpert MTB/RIF and/or microbiological culture and confirmed HIV-negative at the
 time of TB diagnosis.

 • Fourth case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB
 complex identified from a sputum specimen, taken up to four weeks after initiation of TB
 treatment, by Xpert MTB/RIF and/or microbiological culture.

 • Fifth case definition: A subject for whom a clinician has diagnosed TB disease and has
 decided to treat the patient with TB treatment.
Inclusion 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.

 -  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.

 -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
 hysterectomy, ovariectomy or post-menopause.

 -  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.

 Exclusion Criteria:

 -  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.

 -  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.