Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: GSK's candidate Mycobacterium tuberculosis vaccine 692342; Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system; Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline; Control vaccine with the adjuvant system.
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; 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: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis

Summary:

      This study will assess the safety and immunogenicity of 2 different formulations of
      tuberculosis vaccine GSK692342 in healthy adults.
    

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.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Subjects must have PPD negative skin reactivity (0 mm induration 48 to 72 hours after
             PPD skin test administration).

          -  Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT),
             aspartate aminotransferase (AST), complete blood count (CBC) and differential,
             haemoglobin, platelet count and urinalysis.

          -  Seronegative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibodies, hepatitis
             B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies

          -  If the subject is female, she must be of non-childbearing potential, or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for two months after completion of the vaccination
             series.

          -  No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB
             infection/disease) as confirmed by chest X-ray.

        Exclusion Criteria:

          -  History of previous exposure to experimental products containing components of the
             experimental vaccine.

          -  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 6
             months prior to the first vaccine dose.

          -  Any chronic drug therapy to be continued during the study period. Vitamins and/or
             dietary supplements, herbal medications, birth control pills, anti-histamines for
             seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (nonsteroidal
             anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen are allowed.

          -  History of documented exposure to Mycobacterium tuberculosis.

          -  History of prior vaccination with experimental Mycobacterium tuberculosis vaccines.

          -  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.

          -  Participation in another experimental protocol during the study period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition; or family
             history of congenital or hereditary immunodeficiency.

          -  History of hypersensitivity to vaccines or vaccine components

          -  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.

          -  Volunteers with a personal history of autoimmune disease or who describe a
             first-degree relative with clearly documented autoimmune disease.

          -  History of any neurological disorders or seizures.

          -  History of chronic alcohol consumption 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 planning to
             discontinue contraceptive precautions.