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Trial record 53 of 76 for:    "Rabies" | "Immunologic Factors"

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
Sponsor:
Information provided by (Responsible Party):
Narissara Suratannon, Chulalongkorn University

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.

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency Biological: Verorab® (PVRV; Purified Vero Cell Vaccine) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


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




Primary Outcome Measures :
  1. Rabies neutralizing antibody titer (RFFIT test) [ Time Frame: 1 year ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Narissara - Suratannon, MD 6622564455 ext 14,15 mayzped@gmail.com

Locations
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Thailand
Division of Allergic and Immunology , Department of Pediatrics, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Narissara Suratannon, MD    +66812950190    mayzped@gmail.com   
Contact: Suvanee Charoenlap, MD    +66814729600    suvanee171@gmail.com   
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Narissara - Suratannon, MD Chulalongkorn University

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Responsible Party: Narissara Suratannon, Faculty of Medicine, Chulalongkorn university, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02490956     History of Changes
Other Study ID Numbers: RabiesPID
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Narissara Suratannon, Chulalongkorn University:
Diagnostic immunization with rabies vaccine
Primary immunodeficiency

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Rabies
Immune System Diseases
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs