Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: GSK Biologicals' investigational TB vaccine GSK 692342
Intervention description: 2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adults; Tuberculosis vaccine; HIV negative; healthy; mRNA expression

Summary:

      The purpose of this study is to assess the safety and immunogenicity of two doses of the TB
      vaccine administered according to a 0, 1 month schedule. In, addition, blood samples
      collected at different time points after vaccination will be analysed to see when exactly
      genes are activated by the vaccine using an assay called mRNA expression profiling. The
      different methods for mRNA expression profiling using whole blood samples versus Peripheral
      Blood Mononuclear cell(s) (PBMCs), will also be compared.
    

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 informed consent obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Known BCG vaccination or presence of a BCG scar.

          -  Seronegative for human immunodeficiency virus-1.

          -  Female 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 screening and the day of first
                  vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series.

        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 (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within six months prior to the first vaccine dose (for
             corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent). Inhaled and
             topical steroids are allowed.

          -  Administration of long-acting immune-modifying drugs starting 2 years before the first
             dose and planned administration during the study.

          -  Planned administration/administration of a vaccine/product not foreseen by the study
             protocol within the period starting 30 days before the first dose of study vaccine and
             ending at the last study visit.

          -  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 vaccine/product (pharmaceutical product or device).

          -  History of TB disease.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  QuantiFERON® TB Gold positive test result.

          -  History of medically confirmed autoimmune disease.

          -  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 of hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.