Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
Condition: Tuberculosis; Tuberculosis Vaccines
MeSH terms: Tuberculosis
Intervention: GSK Biologicals' investigational TB vaccine (GSK692342); Placebo
Intervention description: 2 doses administered intramuscularly in the deltoid region of the arm.; 2 doses administered intramuscularly in the deltoid region of the arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3575.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Positive Interferon-γ release assay; Efficacy; Adults; Tuberculosis vaccine; Endemic region

Summary:

      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.
    

Eligibility criteria:

        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.