Diagnostic Immunization With Rabies Vaccine in Patients With PID
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|ClinicalTrials.gov Identifier: NCT02490956|
Recruitment Status : Unknown
Verified July 2015 by Narissara Suratannon, Chulalongkorn University.
Recruitment status was: Recruiting
First Posted : July 7, 2015
Last Update Posted : July 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Primary Immunodeficiency||Biological: Verorab® (PVRV; Purified Vero Cell Vaccine)||Phase 4|
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
- 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 :
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 .
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency Disorders|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Rabies vaccination
Biological: Verorab® (PVRV; Purified Vero Cell Vaccine)
- Rabies neutralizing antibody titer (RFFIT test) [ Time Frame: 1 year ]
- Lymphocyte proliferation response to rabies antigen (3H-Thymidine incorporation assay) [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490956
|Contact: Narissara - Suratannon, MD||6622564455 ext 14,firstname.lastname@example.org|
|Division of Allergic and Immunology , Department of Pediatrics, Faculty of Medicine, Chulalongkorn University||Recruiting|
|Bangkok, Thailand, 10330|
|Contact: Narissara Suratannon, MD +66812950190 email@example.com|
|Contact: Suvanee Charoenlap, MD +66814729600 firstname.lastname@example.org|
|Principal Investigator:||Narissara - Suratannon, MD||Chulalongkorn University|