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

Not Applicable

Completed

• Conditions: Rabies
• Interventions: Biological: Equine Rabies Immunoglobulin; Biological: Purified chick-embryo cell rabies vaccine

• Registration Number: NCT03093545
• Lead Sponsor: Mahidol University

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 \< 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.

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 \< 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Study First Submitted: 2017-01-24
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 < 25;
4. Agree to independently consent to participate in all study procedures.

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Exclusion Criteria

1. Positive skin test to ERIG or known hypersensitivity to ERIG or its excipients;
2. Co-enrolment with other studies or participated in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug;
3. Female patients who are currently pregnant or breast feeding.
4. Presenting with wound at eye(s) or eye lid(s);
5. Receiving rabies vaccination more than 7 days for this exposure;
6. History of complete pre-exposure or post-exposure regimen with at least 3 doses;
7. Known of allergic to egg or poultry meat;
8. History of previous exposure to equine sera
9. Significant illness that might harm or increase the risk to the patients;
10. History of drug abuse or alcoholism.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal BMI or underweight (< 24 Kg/m2)	Equine Rabies Immunoglobulin	-
Obese (BMI > 30 Kg/m2)	Equine Rabies Immunoglobulin	-
Obese (BMI > 30 Kg/m2)	Purified chick-embryo cell rabies vaccine	-
Normal BMI or underweight (< 24 Kg/m2)	Purified chick-embryo cell rabies vaccine	-

Primary Outcome Measures

Name	Time	Method
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.	At day 28 prior to vaccination.	To compare RVNA levels between obese and normal/underweight patients.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse event	From day 0 to day 60	Number of participants with ERIG or PCEC-related adverse events as assessed by investigator as per CTCAE v4.03.

Trial Locations

Locations (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand