Efficacy of BCG Revaccination Compared With Oral Chemoprophylaxis in Household Contacts Aged 6-18 Years for Prevention of Tuberculosis Disease - A Phase III Open Labelled Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 9,200
- 试验地点
- 1
- 主要终点
- Incidence of TB (all forms - PTB / EPTB) as per NTEP guidelines
研究概览
简要总结
Bacille Calmette Guerin (BCG) vaccine is one of the most used vaccines of the world, to reduce the risks of natural tuberculous infection. The efficacy of BCG vaccination in newborns is well known and has a documented protective effect against meningitis and disseminated TB in children. However, there is considerable uncertainty on BCG revaccination. It is known that BCG revaccination enhances immune responses, but it is yet to be established if BCG revaccination can help prevent TB disease in household contacts.
The primary aim of this study is to assess the efficacy of BCG revaccination compared to oral chemoprophylaxis in preventing TB disease in house hold contacts aged 6-18 years.
The study is designed as a multicentre randomised controlled trial with two groups of healthy household contacts aged 6-18 years receiving either the BCG vaccine or oral chemoprophylaxis. They will be followed up for 24 months to compare the incidence of TB disease in each arm.
详细描述
Objectives
Primary:
To demonstrate the effect of BCG revaccination in comparison to oral chemoprophylaxis on the incidence of Mycobacterium tuberculosis disease in healthy household contacts aged 6-18 years.
Secondary:
- To compare the safety of BCG revaccination with oral chemoprophylaxis
- To study the efficacy of BCG revaccination in comparison to oral chemoprophylaxis in preventing Mycobacterium tuberculosis infection
- To study the immunogenicity of BCG revaccination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy household contacts aged 6 to 18 yr
- •Previously vaccinated with BCG at birth or least 5 years ago - evidence of scar or documented immunisation record.
- •General good health - through history and baseline screening
- •Agrees to continue in the study for 2 years post enrollment
- •Children previously treated for LTBI and completed treatment at least 6 months ago - can also be included. However, they should be current HHC
排除标准
- •Any acute illness on recruitment day (Evaluate the child again at a later stage)
- •Fever ≥38 degree Celsius on recruitment day (Evaluate the child again at a later)
- •History of autoimmune disease
- •Pregnancy - female participants > 15 years of age will have pregnancy test done after caretakers and participants informed consent
- •Evidence of active TB disease
- •On treatment for active TB disease or LTBI
- •HIV positive or any history or present possible immunodeficiency condition
- •History of allergic reactions to vaccines in past
- •Pre-existing liver dysfunction
- •ALT/AST is ≥ 3 times upper limit of normal (ULN) in the presence of symptoms or ≥ 5 times the ULN in the absence of symptoms and/or total bilirubin greater than ULN along with raised ALT/AST.
研究组 & 干预措施
vaccine - Bacille Calmette-Guérin vaccine (BCG )
Bacille Calmette-Guérin vaccine (BCG ) dose 0.1ml intradermal
干预措施: BCG vaccine (Biological)
Chemoprophylaxis - as per NTEP guidelines
Oral chemoprophylaxis: according to the existing standard of care (NTEP guidelines) Either six months of isoniazid (10mg/kg) or Rifapentine and isoniazid weekly for 3 months for DS TB Levofloxicillin or standard of care drug for DR TB: 15-20mg/kg/day
干预措施: Oral Chemoprophylaxis (Drug)
结局指标
主要结局
Incidence of TB (all forms - PTB / EPTB) as per NTEP guidelines
时间窗: over 24 months
Incidence of TB in BCG revaccinated and oral chemoprophylaxis groups (age and gender stratified)
次要结局
- MTB infection(24 months)
- Adverse events(24 months)