Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers
研究概览
简要总结
CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.
详细描述
Initially, healthy volunteers will be vaccinated to be compared with patients' antibody response to hepatitis A and B vaccine.
The connected part of this study is to vaccinate children suffering from latent tuberculosis against hepatitis B and to measure whether the immunization is related to specific interferon gamma response against Mycobacterium tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CF patients not previously immunized against hepatitis A or B
- •Healthy volunteers not previously immunized against hepatitis A or B
- •Age over 1 year
排除标准
- •Previously transplanted patients
- •Previous vaccination with hepatitis vaccine
- •Known allergy against components in Twinrix (TM)
研究组 & 干预措施
Healthy volunteers
Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.
干预措施: Vaccination with vaccine against hepatitis A and B (Biological)
Cystic Fibrosis
Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.
干预措施: Vaccination with vaccine against hepatitis A and B (Biological)
结局指标
主要结局
Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers
时间窗: 6 months for vaccination
次要结局
未报告次要终点
研究者
Ferenc Karpati, MD
MD, PhD
Karolinska University Hospital