Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.

This is an interventional prevention trial for Tuberculosis focused on measuring Tuberculosis vaccine Read More

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.