Diagnostic Immunization With Rabies Vaccine in Patients With PID

Primary Immunodeficiency Clinical Trial

Official title:

Diagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02490956
• Other study ID #: RabiesPID
• Status: Recruiting
• Phase: Phase 4
• First received: March 30, 2015
• Last updated: July 2, 2015
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2015
• Source: Chulalongkorn University
• Contact: Narissara - Suratannon, MD
• Phone: 6622564455
• Email: mayzped[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 60 Years

Eligibility

Inclusion Criteria:

• Case group

1. Patient with primary immunodeficiency diseases who follows up at Division of pediatric allergy and immunology unit, King Chulalongkorn Memorial Hospital

2. Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.

3. Subject is able to comply with the follow-up schedule of the protocol

• Control group

1. Subject is healthy (from history and physical examination)

2. Subject do not has underlying diseases.

3. Subject do not has primary and secondary immunodeficiency diseases

4. Subject is not receiving immunosuppressive therapy or cytotoxic drugs

5. Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.

6. Subject is able to comply with the follow-up schedule of the protocol

7. Age more than 12 month old to 60 years old

Exclusion Criteria:

1. Reported history of previous rabies immunization or Rabies neutralizing antibody (Rabies Nab) > 0.5 IU/ml

2. Subject is unable to comply with the follow-up schedule of the protocol

3. Pregnancy

4. Body temperature more than 38 degree celcius at screening visit

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency

Intervention

Biological:
• Verorab® (PVRV; Purified Vero Cell 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

Locations

Country	Name	City	State
Thailand	Division of Allergic and Immunology , Department of Pediatrics, Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rabies neutralizing antibody titer (RFFIT test)		1 year	Yes
Secondary	Lymphocyte proliferation response to rabies antigen (3H-Thymidine incorporation assay)		1 year	Yes