CTRI/2011/091/000065进行中（未招募）2 期
Safety and immunogenicity of GSK Biologicals' candidate tuberculosis vaccine (692342) when administered to HIV-positive adults living in a TB endemic region.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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