Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Manila, 1000, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.