Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
研究概览
简要总结
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
详细描述
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages of >= 18 years and older;
- •Experienced WHO category III rabies exposure excluding presenting wound at eye(s) or eye lid(s);
- •Either a) obese with BMI >= 30 or b) normal weight and/or underweight with BMI < 25;
- •Agree to independently consent to participate in all study procedures.
排除标准
- •Positive skin test to ERIG or known hypersensitivity to ERIG or its excipients;
- •Co-enrolment with other studies or participated in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug;
- •Female patients who are currently pregnant or breast feeding.
- •Presenting with wound at eye(s) or eye lid(s);
- •Receiving rabies vaccination more than 7 days for this exposure;
- •History of complete pre-exposure or post-exposure regimen with at least 3 doses;
- •Known of allergic to egg or poultry meat;
- •History of previous exposure to equine sera
- •Significant illness that might harm or increase the risk to the patients;
- •History of drug abuse or alcoholism.
结局指标
主要结局
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
时间窗: At day 28 prior to vaccination.
To compare RVNA levels between obese and normal/underweight patients.
次要结局
- Incidence of adverse event(From day 0 to day 60)
研究者
Jatuporn Sirikun
Principal Investigator
Mahidol University