Rabies
Conditions
Keywords
rabies, obese, immunoglobulin, rabies vaccine, post-exposure, immunogenicity
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.
Interventions
BIOLOGICALEquine Rabies Immunoglobulin
40 IU per kg of body weight of ERIG at Day 0
1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.
Sponsors
VINS Bioproducts Ltd.
Biogentech Co.,LTD
Mahidol University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. | At day 7 prior to vaccination. | To compare RVNA levels between obese and normal/underweight patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Thailand
Outcome results
None listed