Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
研究概览
简要总结
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.
详细描述
- Controlled trial study.
- All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups.
group 1 : 15 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 20 IU/kg of human rabies immune globulin (HRIG).
group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG).
5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 for rabies neutralizing antibody titers (RNab).
The GMTs of RNab among both groups would be analyzed and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •healthy volunteers age 18-60 years.
排除标准
- •received prior rabies immunization
- •pregnancy
- •immunocompromised conditions
研究组 & 干预措施
5-dose IM rabies vaccines, HRIG 20 IU/kg
Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg
干预措施: Human Rabies Immune Globulin (Biological)
5-dose IM rabies vaccines, HRIG 40 IU/kg
Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg
干预措施: Human Rabies Immune Globulin (Biological)
结局指标
主要结局
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
时间窗: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg would be determined on day 0,14, 28 and 90. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
次要结局
- Number of participants who have Rabies Neutralizing antibody titers above protective levels.(Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..)
研究者
Suda Sibunruang
Principal investigator
Queen Saovabha Memorial Institute