This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals'
candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
- Healthy male or female between 18 and 40 years of age at the time of screening
- Negative PPD skin test at screening.
- Subjects must have chest X-ray showing no evidence of pulmonary pathology.
- Female subjects of childbearing potential must have a negative serum pregnancy test
at screening, must not be breast-feeding and are required to use adequate
contraception from enrolment till 1 month after dose 3.
- Screening laboratory values must be within the laboratory normal ranges.
- Negative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibody, hepatitis B
surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
- Subjects must give written informed consent.
- Subjects must be willing to make all evaluation visits, be readily reachable by
telephone or personal contact by the study site personnel and have a permanent
- Subjects' resting seated vital signs must be within the protocol-defined ranges.
- History of prior Bacillus Calmette-Guérin (BCG) vaccinations.
- History of documented exposure to Mycobacterium tuberculosis.
- History of previous administration of experimental Mycobacterium tuberculosis
vaccines or previous exposure to experimental products containing components of the
- History of employment in a healthcare facility in a capacity that had direct or
indirect contact with TB patients.
- Administration of any immunoglobulins or any immunotherapy within the 3 months
preceding the first dose of study vaccination, and/or any blood products within the 4
months preceding HIV screening, or planned administrations during the study period.
- Use of St. John's Wort within six months of the Day 0 visit or planned
administrations during the study period.
- Participation in another experimental protocol and/or receipt of any investigational
products within 30 days prior to Day 0.
- History of autoimmune disease or causes of immunosuppressive states.
- 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
- History of significant psychiatric illness.
- Current drug or alcohol abuse
- History of previous anaphylaxis or severe allergic reaction to vaccines or any other
- Subjects who are, in the opinion of the investigator, at significantly increased risk
of non-cooperation with requirements of the study protocol.
- Any chronic drug therapy to be continued during the study period, with the exception
of vitamins and/or dietary supplements (including mineral preparations such as
calcium carbonate), herbal medications except St. John's Wort, birth control pills,
anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs
(e.g. aspirin, ibuprofen), and acetominophen.
- Chronic administration (defined as more than 14 days total) of immunosuppressants or
other immune modifying drugs within six months prior to the first vaccine dose.
- History of chronic or intermittently recurring illnesses such as migraine headaches,
diabetes, heart disease, and asthma.
- Current administration of anti-TB prophylaxis or therapy.
- History of administration of a live attenuated virus vaccine within 30 days of
- History of administration of a subunit or killed vaccine within 14 days of