Safety and immunogenicity study of a candidate tuberculosis vaccine in HIV-positive adults.
- Registration Number
- CTRI/2011/091/000065
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 240
• 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 59 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to any study procedure.
Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination,
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
• Clinically acceptable laboratory values at screening as determined by the investigator.
No evidence of tuberculosis disease with no evidence of pulmonary pathology as confirmed by chest X-ray.
• No history of extra pulmonary tuberculosis.
Based on their medical history, all subjects must have no history of chemotherapy for tuberculosis.
• Additional inclusion criteria for subjects to be enrolled in HIV+ on highly active antiretroviral therapy cohort:
• Subjects must be HIV-positive and under care of a physician for at least 6 months.
• Subjects must have a CD4+T cell count greater than or equal to 250 cells/mm3 at screening.
• Subjects must be stable on highly active antiretroviral therapy for at least 6 months, with an undetectable HIV viral load level at screening.
• Additional inclusion criteria for subjects to be enrolled in HIV+ treatment naïve cohort:
• Subjects must be HIV-positive and under care of a physician for at least 6 months
• Subjects must be highly active antiretroviral therapy-naïve (never received anti-retrovirals after HIV diagnosis)
• Subjects must have a CD4 + T cell count above 350 cells/mm3 at screening.
• Subjects for whom commencement of highly active antiretroviral therapy is not expected based on current assessment within next year.
• Subjects must have a viral load between 5000 - 80000 copies/mL at screening.
• Additional inclusion criteria for subjects to be enrolled in HIV-negative cohort
Subjects must be negative for HIV-1.
• Use of any investigational or non-registered product 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 Mtb vaccines.
• History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine.
• Chronic administration of immunosuppressant or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Any condition or illness 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 with an experimental product during the study period.
• Administration of any immunoglobulin, 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.
• Subjects taking any of the following medication: chronic administration of systemic steroids, interleukins, systemic interferon or systemic chemotherapy.
• History of allergic reactions or anaphylaxis to any drug or 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 Investigators opinion would put the subject at risk.
• Pregnant female, lactating female or female planning to become pregnant or stop contraception.
• Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests.
• Additional exclusion criteria for subjects to be enrolled in HIV+ on highly active antiretroviral therapycohort:
• Any change in anti-retroviral drug regimen within 12 weeks prior to screening.
• Any chronic drug therapy, other than highly active antiretroviral therapy or prophylaxis for opportunistic HIV related infections, birth control pills, anti-histamines for seasonal allergies and SSRIs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method