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

Primary Purpose

Rabies

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Equine Rabies Immunoglobulin

Purified chick-embryo cell rabies vaccine

About this trial

This is an interventional treatment trial for Rabies focused on measuring rabies, obese, immunoglobulin, rabies vaccine, post-exposure, immunogenicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Medicine, Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Normal BMI or underweight (< 24 Kg/m2)

Obese (BMI > 30 Kg/m2)

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Incidence of adverse event

Number of participants with ERIG or PCEC-related adverse events as assessed by investigator as per CTCAE v4.03.

Full Information

NCT ID

NCT03093545

First Posted

January 24, 2017

Last Updated

March 31, 2017

Sponsor

Mahidol University

Collaborators

VINS Bioproducts Ltd., Biogentech Co.,LTD

1. Study Identification

Unique Protocol Identification Number

NCT03093545

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

VINS Bioproducts Ltd., Biogentech Co.,LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rabies

Keywords

rabies, obese, immunoglobulin, rabies vaccine, post-exposure, immunogenicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal BMI or underweight (< 24 Kg/m2)

Arm Type

Other

Arm Title

Obese (BMI > 30 Kg/m2)

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Equine Rabies Immunoglobulin

Other Intervention Name(s)

ERIG

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Purified chick-embryo cell rabies vaccine

Other Intervention Name(s)

PCEC

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At day 7 prior to vaccination.

Title

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

Description

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

Time Frame

At day 14 prior to vaccination.

Title

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

Description

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

Time Frame

At day 28 prior to vaccination.

Secondary Outcome Measure Information:

Title

Incidence of adverse event

Description

Number of participants with ERIG or PCEC-related adverse events as assessed by investigator as per CTCAE v4.03.

Time Frame

From day 0 to day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Faculty of Medicine, Siriraj Hospital, Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to provide individual participant data (IPD). However, other researcher could request IPD from principal investigator.

Learn more about this trial

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

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