Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response

April 5, 2018 updated by: Suda Sibunruang, Queen Saovabha Memorial Institute
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Controlled trial study.
  • All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups.

group 1 : 15 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 20 IU/kg of human rabies immune globulin (HRIG).

group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 for rabies neutralizing antibody titers (RNab).

The GMTs of RNab among both groups would be analyzed and compared.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Queen Saovabha Memorial Institute, Thai Red Cross Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers age 18-60 years.

Exclusion Criteria:

  • received prior rabies immunization
  • pregnancy
  • immunocompromised conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5-dose IM rabies vaccines, HRIG 20 IU/kg
Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg
Biological: Human Rabies Immune Globulin
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Other Names:
  • Human Rabies Immune Globulin produced by Thai Red Cross
Experimental: 5-dose IM rabies vaccines, HRIG 40 IU/kg
Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg
Biological: Human Rabies Immune Globulin
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Other Names:
  • Human Rabies Immune Globulin produced by Thai Red Cross

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
Time Frame: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg would be determined on day 0,14, 28 and 90. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who have Rabies Neutralizing antibody titers above protective levels.
Time Frame: Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..
Number of participants who have Rabies Neutralizing antibody titers above protective levels (> 0.5 IU/mL as recommended by WHO)at 3-month period.
Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Saovabha Memorial Institute

Investigators

  • Principal Investigator: Suda Sibunruang, M.D., Queen Saovabha Memorial Institute, Thai Red Cross Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC5504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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