Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rabies neutralizing antibody titers
研究概览
简要总结
A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.
详细描述
A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected patients
- •Age 18 - 60 years
- •Received primary rabies immunization
排除标准
- •Have any active opportunistic infections
- •Received blood or blood product within 3 months
- •Allergy to vaccine or any vaccine components
- •Received anti-malarial drugs
研究组 & 干预措施
Intramuscular vaccination
0.5 ml of rabies vaccine is injected to one arm on day 0 and 3.Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
干预措施: rabies vaccine (Biological)
Four-site intradermal vaccination
0.1 ml of rabies vaccine is distributed to 4 sites over both arms and thigh intradermally on day 0. Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
干预措施: rabies vaccine (Biological)
结局指标
主要结局
Rabies neutralizing antibody titers
时间窗: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)
次要结局
- Specific T cell response(Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks)
- Cytokines assessment(Change from baseline of cytokines levels at 1 week)
研究者
Suda Sibunruang
Principal investigator
Queen Saovabha Memorial Institute