Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 22
- 主要终点
- Number of Participants With Protective Levels of Antibodies After Treatment
研究概览
简要总结
Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B. To provide Health workers-staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B vaccine.
详细描述
An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B.
Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community).
- •Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti HBsAb titers <10 mIU / ml following the application of six doses of conventional vaccine at 20 μg doses (two complete guidelines).
排除标准
- •Known allergy to the active substance or any of the other ingredients of the medicinal product (included in section 6 of the product data sheet).
- •Subjects that have ever had an allergic reaction to any vaccine against hepatitis B.
- •Subjects have a serious infection with fever.
- •Subjects for whom informed consent is not obtained.
- •Subjects that have not revoked the consent initially signed.
结局指标
主要结局
Number of Participants With Protective Levels of Antibodies After Treatment
时间窗: Between 40 and 60 days after the last dose given
Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose.
次要结局
未报告次要终点