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

Rabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093545
• Other study ID #: Si178/2015
• Status: Completed
• Phase: N/A
• First received: January 24, 2017
• Last updated: March 31, 2017
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• Equine Rabies Immunoglobulin
40 IU per kg of body weight of ERIG at Day 0
• Purified chick-embryo cell rabies vaccine
1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Mahidol University	Biogentech Co.,LTD, VINS Bioproducts Ltd.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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