Diagnostic Immunization With Rabies Vaccine in Patients With PID

July 2, 2015 updated by: Narissara Suratannon, Chulalongkorn University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Division of Allergic and Immunology , Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rabies vaccination
  • 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rabies neutralizing antibody titer (RFFIT test)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Lymphocyte proliferation response to rabies antigen (3H-Thymidine incorporation assay)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Narissara - Suratannon, MD, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RabiesPID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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