safety and immunogenicity of a candidate tuberculosis (tb) vaccine in hiv-positive adults.

Conditions: Tuberculosis

Summary: this study will assess the safety and immunogenicity of a gsk biologicals' candidate tb vaccine (692342) administered at 0, 1 month to hiv-positive adults living in switzerland.


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. * subjects must be hiv-positive and must have: * received highly active antiretroviral therapy for a minimum of 12 consecutive months prior to screening * documented suppressed hiv-1 rna levels following haart-treatment. * a protocol defined cd4+ t cell count at screening * if the subject is female, she must be of non-childbearing potential, or 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 vaccination. * clinically acceptable laboratory values prior to randomisation as determined by the investigator. * no evidence of tb disease with no pulmonary pathology as confirmed by chest x-ray. * no history of extrapulmonary tb. * no history of chemotherapy for tb. exclusion criteria: * any change in antiretroviral drug regimen within 12 weeks prior to screening. * 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. * administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine. * history of previous administration of experimental mycobacterium tuberculosis vaccines. * history of previous exposure to experimental products containing components of the experimental vaccine. * chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose. * 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. * any condition or illness (acute, chronic or history) or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine. * planned participation or participation in another experimental protocol during the study period. * a family history of congenital or hereditary immunodeficiency. •any chronic drug therapy, other than haart or prophylaxis for opportunistic hiv-related infections to be continued during the study period. vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and ssris are allowed. * subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy. * history of allergic reactions or anaphylaxis to any vaccine. * 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 which in the investigator's opinion would put the subject at risk. * pregnant female, lactating female or female planning to become pregnant or stop contraception.

Keywords: tuberculosis vaccine