safety and immunogenicity study of gsk biologicals tuberculosis vaccines (692342) to healthy adults

Conditions: Tuberculosis

Summary: 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.


Eligibility criteria:
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.

Keywords: tuberculosis vaccine