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Completed

NCT Number: NCT03093545

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Equine Rabies Immunoglobulin

Biological

40 IU per kg of body weight of ERIG at Day 0

Other names: ERIG

Purified chick-embryo cell rabies vaccine

Biological

1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.

Other names: PCEC

Primary outcomes

  1. The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.

    Time frame: At day 7 prior to vaccination.

    To compare RVNA levels between obese and normal/underweight patients.

  2. The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.

    Time frame: At day 14 prior to vaccination.

    To compare RVNA levels between obese and normal/underweight patients.

  3. The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.

    Time frame: At day 28 prior to vaccination.

    To compare RVNA levels between obese and normal/underweight patients.

Secondary outcomes

  1. Incidence of adverse event

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Biogentech Co.,LTD
  • VINS Bioproducts Ltd.

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2017
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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