PACTR201808711101850Other2 期
A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of H56:IC31 in Reducing the rate of TB Disease Recurrence in HIV Negative Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis
IAVI South Africa NPC0 个研究点目标入组 900 人开始时间: 2018年7月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 900
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Completed the written informed consent process.
- •2.Agrees to give access to medical records for study related purposes.
- •3.HIV-negative (self-reported) with a diagnosis of drug susceptible pulmonary TB at the start of the TB treatment.
- •4.Able to provide 2 separate sputum samples within = 7 days of starting TB treatment. Participants are not expected to provide sputum samples prior to starting TB treatment if their 1st screening visit (V1) is performed on the same day as their 2nd screening visit (V2).
- •5.Tested Mtb negative by smear AFB microscopy of 2 separate sputum samples taken on V2. Participants unable to produce sputum, but considered asymptomatic by the investigator, may be considered Mtb negative and eligible for inclusion.
- •6.Confirmed HIV negative on V2.
- •7.Completed = 5 months (22 weeks) of TB treatment with treatment still ongoing at the time of the 1st vaccination on V3= Day 0, and total treatment time not extended beyond 28 weeks.
- •8.Aged = 18 years on the date of V1 and = 60 years on the date of V3= Day 0.
- •9.Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the area for the duration of the study.
排除标准
- •1.Diagnosis or co-diagnosis of extra pulmonary TB.
- •2.Hospitalized for the current episode of drug susceptible pulmonary TB disease.
- •3.History of receipt of treatment against active TB, prior to the current treatment episode, within the last 5 years.
- •4.History of or ongoing severe disease that in the opinion of the investigator might affect the safety of the participant or the immunogenicity of the investigational product.
- •5.Insulin dependent diabetes.
- •6.History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
- •7.History or laboratory evidence of immunodeficiency, autoimmune disease or immunosuppression.
- •8.History of chronic hepatitis.
- •9.Severe anemia, defined as hemoglobin less than 10 g/dL or a hematocrit less than 30 % based on most recent hematology obtained before randomization.
- •10.Receipt of any investigational TB vaccine previously.
- •11.Receipt or planned receipt of any investigational drug or investigational vaccine from V1 through V8= Day 421.
- •12.Receipt or planned receipt of any licensed vaccine from V1 through V6= Day 70, except for SARS-Cov-2 vaccines recommended by national vaccination programs which will be allowed if given > 28 days before and from the time of administration of clinical trial product.
- •13.Receipt of treatment likely to modify the immune response (e.g. blood products, immunoglobulins, immunosuppressive treatment) within 42 days before V3= Day 0 through V6= Day 70. Inhaled and topical corticosteroids are permitted.
- •14.Has a body mass index (BMI) < 13 (weight, kg / height, m2) on the date of V1.
- •15.Female participants of childbearing potential (not sterilized, menstruating or within 1 year of last menses, if post-menopausal): if not willing to use an acceptable method to avoid pregnancy (sterile sexual partner, sexual abstinence, hormonal contraceptives (oral, injection, transdermal patch, or implant) or intrauterine device from 28 days before V3= Day 0 until 2 months
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