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

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.

Study Overview

• Status: Completed
• Conditions: Rabies
• Intervention / Treatment: Biological: Equine Rabies Immunoglobulin; Biological: Purified chick-embryo cell rabies vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine, Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: VINS Bioproducts Ltd.; Biogentech Co.,LTD

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (ACTUAL): March 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: immunogenicity; obese; immunoglobulin; rabies; rabies vaccine; post-exposure
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Rhabdoviridae Infections; Rabies; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: Si178/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to provide individual participant data (IPD). However, other researcher could request IPD from principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No