Primary Immunodeficiency Clinical Trial
Official title:
Diagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency Disorders
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.
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
Vaccine :
- Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular
- Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year
later on days 360 and 363
Immunological evaluations :
1. Humoral immune response :
on 5 ml blood samples will be collected for antibody determination days 0, 14, 28, 90,
360, 367 and 374. Neutralizing antibodies will be determined blindly using the rapid
fluorescent focus inhibition test (RFFIT) at Queen Saovabha Memorial Institute. Rabies
neutralizing antibody will be reported in IU/ml The protective antibody level are
defined rabies neutralizing antibody ≥ 0.5 IU/ml .
2. Cellular mediated immune response :
On 5 ml blood samples will be collected for antibody determination days 14, 28, 90, 360, 367
and 374. Lymphocyte proliferation response to rabies antigen will be determined by using
3H-thymidine incorporation assay.
The responder criteria are defined as stimulation index (SI index) ≥ 2.0 was considered as
evidence of antigen-induced lymphocyte proliferation.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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