safety and immunogenicity of a candidate tuberculosis (tb) vaccine given to ppd-negative adults

Conditions: Tuberculosis (TB)

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 address. * subjects' resting seated vital signs must be within the protocol-defined ranges. exclusion criteria: * 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 experimental vaccine. * 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 the vaccine. * history of significant psychiatric illness. * current drug or alcohol abuse * history of previous anaphylaxis or severe allergic reaction to vaccines or any other allergen. * 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 enrollment. * history of administration of a subunit or killed vaccine within 14 days of enrollment.

Keywords: tuberculosis vaccine