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Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients

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Disease Information

Descriptive Information
Brief Title † Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients
Official Title † Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients
Brief 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
Detailed Description 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
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
Secondary Outcome Measure † Incidence of adverse event
Condition † Rabies
Intervention † BiologicalEquine Rabies Immunoglobulin
Study Arms / Comparison Groups Normal BMI or underweight ( 30 Kg/m2)
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 60
Start Date † March 2015
Completion Date November 2016
Primary Completion Date October 2016
Eligibility Criteria † Inclusion Criteria: 1. Male or female ages of >= 18 years and older; 2. Experienced WHO category III rabies exposure excluding presenting wound at eye(s) or eye lid(s); 3. Either a) obese with BMI >= 30 or b) normal weight and/or underweight with BMI
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Thailand
Administrative Information
NCT ID † NCT03093545
Organization ID Si178/2015
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Mahidol University
Collaborators †† VINS Bioproducts Ltd.
Investigators † : ,
Information Provided By
Verification Date March 2017
First Received Date † January 24, 2017
Last Updated Date March 31, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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