Diagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency Disorders
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rabies neutralizing antibody titer (RFFIT test)
研究概览
简要总结
The purpose of this study is to evaluate diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders and study humoral and cellular immune response to rabies vaccine in patients with primary immunodeficiency.
详细描述
Objective Primary objective
: To study diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders. Secondary objective
- To study humoral and cellular immune response to rabies vaccine in patients with primary immunodeficiency.
- To study anti-rabies immunization protocol in patients with primary immunodeficiency disorders.
Population Case group: Twenty primary immunodeficiency disease patients that are diagnosed, treated and followed at Allergy and Immunology unit, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University.
Control group: Twenty healthy subjects who have no underlying disease and age-matched with case patients. Inclusion and exclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case group
- •Patient with primary immunodeficiency diseases who follows up at Division of pediatric allergy and immunology unit, King Chulalongkorn Memorial Hospital
- •Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.
- •Subject is able to comply with the follow-up schedule of the protocol
- •Control group
- •Subject is healthy (from history and physical examination)
- •Subject do not has underlying diseases.
- •Subject do not has primary and secondary immunodeficiency diseases
- •Subject is not receiving immunosuppressive therapy or cytotoxic drugs
- •Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.
- •Subject is able to comply with the follow-up schedule of the protocol
- •Age more than 12 month old to 60 years old
排除标准
- •Reported history of previous rabies immunization or Rabies neutralizing antibody (Rabies Nab) > 0.5 IU/ml
- •Subject is unable to comply with the follow-up schedule of the protocol
- •Body temperature more than 38 degree celcius at screening visit
结局指标
主要结局
Rabies neutralizing antibody titer (RFFIT test)
时间窗: 1 year
次要结局
- Lymphocyte proliferation response to rabies antigen (3H-Thymidine incorporation assay)(1 year)
研究者
Narissara Suratannon
Faculty of Medicine, Chulalongkorn university
Chulalongkorn University