Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
研究概览
简要总结
Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
- •Completion of the IM HBV vaccine series in infancy.
- •HBsAb titer of <10mIU/mL at the time of enrollment.
排除标准
- •Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathioprine, 6-MP, steroids).
- •Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
研究组 & 干预措施
1
celiac patients who did not respond to initial hepatitis B vaccine series , will receive Sci-B-Vac vaccination series
干预措施: Hepatitis B vaccination (Sci-B-Vac) (Biological)
2
celiac patients who did not respond to initial hepatitis B vaccine series , will receive Engerix 3-dose vaccination series
干预措施: Hepatitis B vaccination (EngerixB) (Biological)
结局指标
主要结局
Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
时间窗: two years
次要结局
- Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response(two years)
- Association between genetic make-up and vaccine response(two years)
- Numerical increase in the antibodies titer before and after vaccination(two years)
- Rate of responders four weeks after the completion of the series(two years)
- Rate and characteristics of adverse drug reactions(two years)
- Rate of responders in the cross over phase.(two years)