Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: GSK Biologicals' AS01B adjuvant; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2
Intervention description: Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses
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: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis vaccine

Summary:

      This observer blind study will assess the safety and immunogenicity of different formulations
      of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a
      positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  A male or female between, and including, 18 and 45 years of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the subject prior to any study procedure.

          -  Free of obvious health problems as established by medical history and clinical
             examination before enrolment into the study.

          -  If the subject is female, she must be of non-childbearing potential or if she is of
             childbearing potential, 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 the vaccination series.

          -  No evidence of pulmonary pathology as confirmed by chest X-ray.

          -  No history of extrapulmonary TB.

          -  Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT),
             aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis.

          -  Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies.

          -  Subjects must have a PPD positive skin reactivity 48 to 72 hours after PPD skin test
             administration.

        Exclusion Criteria:

          -  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.

          -  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, with the exception
             of vitamins and/or dietary supplements, herbal medications, birth control pills,
             anti-histamines for seasonal allergies and SSRIs.

          -  History of previous administration of experimental Mycobacterium tuberculosis
             vaccines.

          -  History of previous exposure to experimental products containing MPL or QS21.

          -  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.

          -  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 (pharmaceutical product or device).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  A family history (first generation) of congenital or hereditary immunodeficiency.

          -  History of any acute or chronic illness or medication that, in the opinion of the
             investigator, may interfere with the evaluation of the safety or immunogenicity of the
             vaccine.

          -  History of any neurological disorders or seizures.

          -  History of allergic reactions or anaphylaxis to previous immunisations.

          -  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.

          -  Major congenital defects.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.