Diagnostic Immunization With Rabies Vaccine in Patients With PID

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02490956
• Date of registration: 30/03/2015
• Prospective Registration: Yes
• Primary sponsor: Chulalongkorn University
• Public title: Diagnostic Immunization With Rabies Vaccine in Patients With PID
• Scientific title: Diagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency Disorders
• Date of first enrolment: April 2015
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02490956
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Narissara Suratannon, MD

• Name: Narissara - Suratannon, MD

• Name: Narissara - Suratannon, MD
• Affiliation: Chulalongkorn University

Key inclusion & exclusion criteria

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



Age minimum: 12 Months
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency

Intervention(s)

Biological: Verorab® (PVRV; Purified Vero Cell Vaccine)

Primary Outcome(s)

Rabies neutralizing antibody titer (RFFIT test) [Time Frame: 1 year]

Secondary Outcome(s)

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

Secondary ID(s)

RabiesPID

Source(s) of Monetary Support

Please refer to primary and secondary sponsors