Clinical trial NCT03093545: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rabies
Keywords: rabies
obese
immunoglobulin
rabies vaccine
post-exposure
immunogenicity
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: VINS Bioproducts Ltd.
name: Biogentech Co.,LTD
First posted: 2017-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \< 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.

Primary outcomes:
measure: The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
timeFrame: At day 7 prior to vaccination.
measure: The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
timeFrame: At day 14 prior to vaccination.
measure: The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
timeFrame: At day 28 prior to vaccination.
Secondary outcomes:
measure: Incidence of adverse event
timeFrame: From day 0 to day 60
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
References: