Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: GSK Biologicals' investigational TB vaccine GSK 692342; Placebo
Intervention description: Intramuscular injection, 2 doses; Intramuscular injection, 2 doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis vaccine; HIV-negative; tuberculosis treatment

Summary:

      This study will assess the safety and immunogenicity of GSK Biologicals' investigational
      tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months
      to human immunodeficiency virus (HIV) negative adults who have received treatment for TB
      disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease
      (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB
      disease (denoted TB-naïve cohort) will also be enrolled.
    

Eligibility criteria:

        Inclusion 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.

          -  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

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series.

          -  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.

               -  have no history of chemoprophylaxis or treatment for 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).

               -  have no active pulmonary disease on chest X-ray.

          -  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.

        Exclusion Criteria:

          -  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.

          -  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:

             - Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal
             function abnormality as determined by physical examination or laboratory screening
             tests

          -  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.