NCT02490956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

March 30, 2015

Last Update Submit

July 2, 2015

Conditions

Primary Immunodeficiency

Keywords

Diagnostic immunization with rabies vaccinePrimary immunodeficiency

Outcome Measures

Primary Outcomes (1)

  • Rabies neutralizing antibody titer (RFFIT test)

    1 year

Secondary Outcomes (1)

  • Lymphocyte proliferation response to rabies antigen (3H-Thymidine incorporation assay)

    1 year

Study Arms (1)

Rabies vaccination

EXPERIMENTAL

* 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)

Interventions

Verorab® (PVRV; Purified Vero Cell Vaccine)BIOLOGICAL

* 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

Rabies vaccination

Eligibility Criteria

Age12 Months - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Case group
  • Patient with primary immunodeficiency diseases who follows up at Division of pediatric allergy and immunology unit, King Chulalongkorn Memorial Hospital
  • Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.
  • Subject is able to comply with the follow-up schedule of the protocol
  • Control group
  • Subject is healthy (from history and physical examination)
  • Subject do not has underlying diseases.
  • Subject do not has primary and secondary immunodeficiency diseases
  • Subject is not receiving immunosuppressive therapy or cytotoxic drugs
  • Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.
  • Subject is able to comply with the follow-up schedule of the protocol
  • Age more than 12 month old to 60 years old

You may not qualify if:

  • Reported history of previous rabies immunization or Rabies neutralizing antibody (Rabies Nab) \> 0.5 IU/ml
  • Subject is unable to comply with the follow-up schedule of the protocol
  • Pregnancy
  • Body temperature more than 38 degree celcius at screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Allergic and Immunology , Department of Pediatrics, Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Narissara - Suratannon, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Narissara - Suratannon, MD

CONTACT

6622564455mayzped@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Medicine, Chulalongkorn university

Study Record Dates

First Submitted

March 30, 2015

First Posted

July 7, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

TH(1)