Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: GSK's candidate Mycobacterium tuberculosis vaccine 692342; Control vaccine with the adjuvant system.; Control vaccine with physiological saline
Intervention description: Intramuscular injection, 2 doses at 0, 1 month; Intramuscular injection, 2 doses at 0, 1 month; Intramuscular injection, 2 doses at 0, 1 month
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Tuberculosis vaccine

Summary:

      This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB
      vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the Investigator believes that they 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 the
             first vaccination.

          -  Written informed consent obtained from the subject prior to any study procedure.

          -  Subjects must be HIV-positive and must have:

               -  received Highly Active Antiretroviral therapy for a minimum of 12 consecutive
                  months prior to screening

               -  documented suppressed HIV-1 RNA levels following HAART-treatment.

               -  a protocol defined CD4+ T cell count at screening

          -  If the subject is female, she must be of non-childbearing potential, or she must
             practice adequate contraception for 30 days prior to vaccination, have a negative
             pregnancy test and continue such precautions for 2 months after completion of
             vaccination.

          -  Clinically acceptable laboratory values prior to randomisation as determined by the
             Investigator.

          -  No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.

          -  No history of extrapulmonary TB.

          -  No history of chemotherapy for TB.

        Exclusion Criteria:

          -  Any change in antiretroviral drug regimen within 12 weeks prior to screening.

          -  Use of any investigational or non-registered product (drug or vaccine) 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.

          -  History of previous administration of experimental Mycobacterium tuberculosis
             vaccines.

          -  History of previous exposure to experimental products containing components of the
             experimental vaccine.

          -  Chronic administration of immunosuppressive or other immune-modifying drugs within six
             months prior to the first vaccine dose.

          -  Administration of any immunoglobulins, any immunotherapy and/or any blood products
             within the three months preceding the first dose of study vaccination, or planned
             administrations during the study period.

          -  Any condition or illness (acute, chronic or history) or medication, which in the
             opinion of the Investigator might interfere with the evaluation of the safety or
             immunogenicity of the vaccine.

          -  Planned participation or participation in another experimental protocol during the
             study period.

          -  A family history of congenital or hereditary immunodeficiency. •Any chronic drug
             therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to
             be continued during the study period. Vitamins and/or dietary supplements, birth
             control pills, anti-histamines for seasonal allergies and SSRIs are allowed.

          -  Subjects taking any of the following medication: systemic steroids, interleukins,
             systemic interferons or systemic chemotherapy.

          -  History of allergic reactions or anaphylaxis to any vaccine.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  History of chronic alcohol consumption and/or drug abuse which in the Investigator's
             opinion would put the subject at risk.

          -  Pregnant female, lactating female or female planning to become pregnant or stop
             contraception.