Trial | NCT03093545  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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 Started
Mar 31
2015
Primary Completion
Oct 31
2016
Study Completion
Nov 30
2016
Last Update
Apr 04
2017

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

Normal BMI or underweight (< 24 Kg/m2) Other

Obese (BMI > 30 Kg/m2) Experimental

Criteria 

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.
No Results Posted