safety and immunogenicity of 2 formulations of tuberculosis vaccine gsk692342 given at 0,1 months to healthy adults

Conditions: Tuberculosis

Summary: this study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine gsk692342 in healthy adults.

the study is designed to have a vaccination phase (includes screening, 2 doses of vaccine 1 month apart and follow-up until 1 month post dose 2), which will be performed in an observer blinded manner. this will be followed by 3 years of follow-up which will continue in an open manner. no new subjects will be recruited at the follow-up phase. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they 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 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 entering into the study. * subjects must have ppd negative skin reactivity (0 mm induration 48 to 72 hours after ppd skin test administration). * clinically normal laboratory values for creatinine, alanine aminotransferase (alt), aspartate aminotransferase (ast), complete blood count (cbc) and differential, haemoglobin, platelet count and urinalysis. * seronegative for human immunodeficiency virus-1 and 2 (hiv 1/2) antibodies, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibodies * if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. * no evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past tb infection/disease) as confirmed by chest x-ray. exclusion criteria: * history of previous exposure to experimental products containing components of the experimental vaccine. * 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 6 months prior to the first vaccine dose. * any chronic drug therapy to be continued during the study period. vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies, ssris (e.g. prozac, zoloft, paxil), nsaids (nonsteroidal anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen are allowed. * history of documented exposure to mycobacterium tuberculosis. * history of prior vaccination with experimental mycobacterium tuberculosis vaccines. * administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period. * participation in another experimental protocol during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency. * history of hypersensitivity to vaccines or vaccine components * 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. * volunteers with a personal history of autoimmune disease or who describe a first-degree relative with clearly documented autoimmune disease. * history of any neurological disorders or seizures. * history of chronic alcohol consumption and/or drug abuse. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects. * pregnant female, lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: tuberculosis