Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients
NCT03093545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2017-04-04
Summary
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI \> 30 kg/m2) and normal weight/underweight (BMI \< 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
Conditions
- Rabies
Interventions
- BIOLOGICAL
-
Equine Rabies Immunoglobulin
40 IU per kg of body weight of ERIG at Day 0
- BIOLOGICAL
-
Purified chick-embryo cell rabies vaccine
1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.
Sponsors & Collaborators
-
VINS Bioproducts Ltd.
collaborator UNKNOWN -
Biogentech Co.,LTD
collaborator UNKNOWN -
Mahidol University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2016-10-31
- Completion
- 2016-11-30
Countries
- Thailand
Study Locations
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