NCT00600782已完成2 期
Immunogenicity and Safety of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342) When Administered to Healthy Adults Aged 21 to 40 Years.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms
研究概览
简要总结
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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, 21 and 40 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject prior to any study procedure.
- •Free of obvious health problems as established by medical history and clinical examination before enrolment into the study.
- •If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, 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 the vaccination series.
- •No evidence of pulmonary pathology as confirmed by chest X-ray.
- •Clinically normal laboratory values for creatinine, ALT, AST and complete blood count.
- •Seronegative for human immunodeficiency virus-1 (HIV-1).
- •No history of extrapulmonary TB.
- •Subjects must have the appropriate PPD skin reactivity (induration measured at 48 to 72 hours after PPD skin test administration).
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- •History of previous administration of experimental Mycobacterium tuberculosis vaccines.
- •History of previous exposure to experimental products containing MPL or QS
- •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.
- •Participation in another experimental protocol during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency. Subjects who describe a first-degree relative with clearly documented autoimmune disease will be excluded
- •History of any acute or chronic illness or medication that, in the opinion of the Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- •Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies, SSRIs.
- •History of any neurologic disorders or seizures.
- •History of allergic reactions or anaphylaxis to previous immunisations.
- •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.
- •Major congenital defects.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
结局指标
主要结局
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
时间窗: During the 30-day follow-up period following vaccination after each vaccine dose
Occurrence and relationship to vaccination of serious adverse events
时间窗: During the entire study period
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
时间窗: During the 7-day follow-up period following vaccination after each vaccine dose
Haematological and biochemical levels
时间窗: At protocol defined time points
次要结局
- Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry(At protocol defined time points)
- Antibody titres to M72 measured by ELISA(At protocol defined time points)
研究者
研究点 (2)
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