CTRI/2020/05/025421尚未招募2 期
Double-Blind, Randomized, Placebo-Controlled, Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination asadjuvant of Tuberculosis chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Percentage of patients with Sputum Culture Negative Difference between intervention and control group
研究概览
简要总结
This is Double-Blind, Randomized, Placebo-Controlled Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as adjuvant of Tuberculosis chemotherapy. A total of 140 adult TB patients (age > 18 years) with culture confirmed DS-TB (Drug Sensitive) (90 patients) (Cohort A) and MDR-TB (Multi Drug Resistant) (50 patients) (Cohort B) will be enrolled in the study. 25 μg RUTI® vaccine will be given subcutaneously in the deltoid region at the predefined time point (week 1 or month 1 upon start of standard DS- or MDR-TB treatment) respectively. The control group will receive a subcutaneous injection with placebo. The primary and secondary endpoint will be evaluated at the end of intensive phase of treatment however, all patients will be followed up for the whole chemotherapy treatment, i.e. 6 and 24 months for Cohort A and B respectively for exploratory endpoint analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with pulmonary DS- or MDR-TB, and managed with standard-care TB drugs accordingly;
- •Attending a TB unit / hospital routinely diagnosed with pulmonary DS- or MDR-TB with clinical status ≥ 6 with Bandim TB score combined with chest radiography; and microbiological criteria (MGIT sputum culture), by using rapid genetic testing, gene Xpert;
- •Patients who have not received any anti-tubercular treatment in last 6 months
- •Females and males aged ≥ 18;.
- •females of non-childbearing potential: at least 2 years post-menopausal or surgically sterile (e.g. tubal ligation);.
- •females of childbearing potential (including females less than 2 years postmenopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control (i.e. diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in the study;.
- •males must agree to use a double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide) while participating in the study; or the male patient or his female partner must be surgically sterile (e.g. vasectomy, tubal ligation) or the female partner must be post-menopausal;
- •The patient must provide written informed consent;
- •The patient must be willing and able to attend all study visits and comply with all study procedures. Inclusion criteria for vaccination
- •Having successfully completed 1 week or 1 month (depending on the cohort) of DS or MDR-TB treatment, respectively, fully supervised; and with beneficial initial response to therapy, evidenced by clinical response.
排除标准
- •Inability to provide written informed consent;
- •Women reported, or detected, or willing to be pregnant during the trial period;
- •Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
- •Patients with extra-pulmonary tuberculosis
- •Major co-morbid conditions precluding full evaluation, i.e., HIV positive, chronic renal failure, chronic liver failure, Malignancy, patients taking any immunosuppressant drug, active lung cancer, acute coronary syndrome, heart failure exceeding NYHA class 2;
- •Presence of secondary immunodeficiency states: Organ transplantation, diabetes mellitus
- •Any of the following laboratory parameters:.
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN).
- •Total bilirubin > 2 x ULN.
- •Neutrophil count ≤ 500 neutrophils / mm
- •Platelet count < 50,000 cells / mm3
- •Cytotoxic chemotherapy or radiation therapy within the previous 3 months;
- •Blood transfusion in the last three weeks prior to the trial; 10.Patients with history of alcohol or drug abuse
- •Documented allergy to TB vaccines, notably, to the RUTI® vaccine.
结局指标
主要结局
Percentage of patients with Sputum Culture Negative Difference between intervention and control group
时间窗: Up to Week 2 for | Cohort A and Month 1.5 for Cohort B
次要结局
- Percentage of patients with Sputum Culture Negative Difference between intervention and control group(Up to Week 8 for)
- Proportion of patients with reduction of bacillary load based upon Time to detection (TTD) signal in(MGIT. Difference between intervention and control group.)
- Proportion of patients with improvement of clinical signs and symptoms based upon Bandim Tb(score. Difference between intervention and control group.)
- Immunological Endpoints(Baseline (week 0),)
- Safety Endpoints(Safety and tolerability (physical examination, serious adverse events (SAEs), routine)
- Exploratory End Points(Percentage of patients with Sputum Culture Negative Difference between intervention and control)
研究者
研究点 (2)
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