NCT00730795已完成1 期
A Phase I Open Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine, Mtb72F With AS02A Adjuvant, When Administered Intramuscularly to Healthy PPD-Negative Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Occurrence of dose limiting toxicity
研究概览
简要总结
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female between 18 and 40 years of age at the time of screening
- •Negative PPD skin test at screening.
- •Subjects must have chest X-ray showing no evidence of pulmonary pathology.
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening, must not be breast-feeding and are required to use adequate contraception from enrolment till 1 month after dose
- •Screening laboratory values must be within the laboratory normal ranges.
- •Negative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
- •Subjects must give written informed consent.
- •Subjects must be willing to make all evaluation visits, be readily reachable by telephone or personal contact by the study site personnel and have a permanent address.
- •Subjects' resting seated vital signs must be within the protocol-defined ranges.
排除标准
- •History of prior Bacillus Calmette-Guérin (BCG) vaccinations.
- •History of documented exposure to Mycobacterium tuberculosis.
- •History of previous administration of experimental Mycobacterium tuberculosis vaccines or previous exposure to experimental products containing components of the experimental vaccine.
- •History of employment in a healthcare facility in a capacity that had direct or indirect contact with TB patients.
- •Administration of any immunoglobulins or any immunotherapy within the 3 months preceding the first dose of study vaccination, and/or any blood products within the 4 months preceding HIV screening, or planned administrations during the study period.
- •Use of St. John's Wort within six months of the Day 0 visit or planned administrations during the study period.
- •Participation in another experimental protocol and/or receipt of any investigational products within 30 days prior to Day
- •History of autoimmune disease or causes of immunosuppressive states.
- •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.
- •History of significant psychiatric illness.
- •Current drug or alcohol abuse
- •History of previous anaphylaxis or severe allergic reaction to vaccines or any other allergen.
- •Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
- •Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements (including mineral preparations such as calcium carbonate), herbal medications except St. John's Wort, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (e.g. aspirin, ibuprofen), and acetominophen.
- •Chronic administration (defined as more than 14 days total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
- •History of chronic or intermittently recurring illnesses such as migraine headaches, diabetes, heart disease, and asthma.
- •Current administration of anti-TB prophylaxis or therapy.
- •History of administration of a live attenuated virus vaccine within 30 days of enrollment.
- •History of administration of a subunit or killed vaccine within 14 days of enrollment.
研究组 & 干预措施
Group A
Experimental
Subjects receiving the low-dose antigen candidate TB vaccine
干预措施: GSK's candidate Mycobacterium tuberculosis vaccine 692342 (Biological)
Group B
Experimental
Subjects receiving the high-dose antigen candidate TB vaccine
干预措施: GSK's candidate Mycobacterium tuberculosis vaccine 692342 (Biological)
结局指标
主要结局
Occurrence of dose limiting toxicity
时间窗: From study start up to Day 56.
Occurrence of serious adverse events
时间窗: During the entire study period.
Occurrence of adverse events
时间窗: At each visit
Laboratory measurements of serum chemistry and hematology
时间窗: At study start, prior to each vaccination and 1 and 6 months after dose 3
Resting vital signs (blood pressure, pulse, temperature)
时间窗: At study start, prior to each vaccination and 1 and 6 months after dose 3
Chest X-ray findings
时间窗: At study start and study end
次要结局
- Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains.(Prior to each vaccination and 1 and 6 months after dose 3)
- Evaluation of PPD skin reactivity(At study start and study end)
研究者
研究点 (1)
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