Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects
研究概览
简要总结
The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against influenza H1N1 in patients with IBD who treated with immunomodulatory drugs.
详细描述
200 patients with IBD and 200 healthy subjects will participate in the study. All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later.
The evaluation will include:
Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test.
Safety of the vaccine:
- Records of adverse event
- Assessment of disease activity : CDAI and MAYO score
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from IBD (inflammatory bowel disease): UC/ CD
- •Able to firm an informed consent
- •Aged - 18-65
- •Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health
- •patients who treated with immunomodulators and biologics
排除标准
- •Allergy to eggs
- •Known allergy to seasonal influenza vaccine
- •Pregnant women
- •Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza
- •Patients without worsening in their disease condition (stable condition)
结局指标
主要结局
Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects
时间窗: 4 weeks
次要结局
- Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score(4 weeks)