Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Subjects who the Investigator believes that they can and will comply with the requirements of the protocol.
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A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
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Written informed consent obtained from the subject prior to any study procedure.
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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
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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.
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Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.
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No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.
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No history of extrapulmonary TB.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
37 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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