Expired Study
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Tacoma, Washington


Purpose:

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.


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.


NCT ID:

NCT00730795


Primary Contact:

Study Director
Clinical Trials
GlaxoSmithKline


Backup Contact:

N/A


Location Contact:

Tacoma, Washington
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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