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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rabies

Intervention / Treatment
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* Biological: Equine Rabies Immunoglobulin
* Biological: Purified chick-embryo cell rabies vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ages of >= 18 years and older; Experienced WHO category III rabies exposure excluding presenting wound at eye(s) or eye lid(s); Either a) obese with BMI >= 30 or b) normal weight and/or underweight with BMI < 25; Agree to independently consent to participate in all study procedures. Exclusion Criteria: Positive skin test to ERIG or known hypersensitivity to ERIG or its excipients; 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; Female patients who are currently pregnant or breast feeding. Presenting with wound at eye(s) or eye lid(s); Receiving rabies vaccination more than 7 days for this exposure; History of complete pre-exposure or post-exposure regimen with at least 3 doses; Known of allergic to egg or poultry meat; History of previous exposure to equine sera Significant illness that might harm or increase the risk to the patients; History of drug abuse or alcoholism.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal BMI or underweight (< 24 Kg/m2)<br> | Biological: Equine Rabies Immunoglobulin<br>* 40 IU per kg of body weight of ERIG at Day 0<br>* Other names: ERIG;Biological: Purified chick-embryo cell rabies vaccine<br>* 1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.<br>* Other names: PCEC;|
| Experimental: Obese (BMI > 30 Kg/m2)<br> | Biological: Equine Rabies Immunoglobulin<br>* 40 IU per kg of body weight of ERIG at Day 0<br>* Other names: ERIG;Biological: Purified chick-embryo cell rabies vaccine<br>* 1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.<br>* Other names: PCEC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. | To compare RVNA levels between obese and normal/underweight patients. | At day 7 prior to vaccination. | 
| The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. | To compare RVNA levels between obese and normal/underweight patients. | At day 14 prior to vaccination. | 
| The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. | To compare RVNA levels between obese and normal/underweight patients. | At day 28 prior to vaccination. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabies, obese, immunoglobulin, rabies vaccine, post-exposure, immunogenicity