Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT02490956
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT02490956
Study Brief:
Protocol Section:
NCT02490956