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

Primary Purpose

Rabies

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Human Rabies Immune Globulin
Sponsored by
Queen Saovabha Memorial Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rabies focused on measuring rabies, immunoglobulin, dosage

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteers age 18-60 years.

Exclusion Criteria:

  • received prior rabies immunization
  • pregnancy
  • immunocompromised conditions

Sites / Locations

  • Queen Saovabha Memorial Institute, Thai Red Cross Society

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

5-dose IM rabies vaccines, HRIG 20 IU/kg

5-dose IM rabies vaccines, HRIG 40 IU/kg

Arm Description

Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg

Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg

Outcomes

Primary Outcome Measures

Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
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.

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2012
Last Updated
April 5, 2018
Sponsor
Queen Saovabha Memorial Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01610362
Brief Title
Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
Official Title
Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Saovabha Memorial Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
rabies, immunoglobulin, dosage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-dose IM rabies vaccines, HRIG 20 IU/kg
Arm Type
Active Comparator
Arm Description
Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg
Arm Title
5-dose IM rabies vaccines, HRIG 40 IU/kg
Arm Type
Experimental
Arm Description
Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg
Intervention Type
Biological
Intervention Name(s)
Human Rabies Immune Globulin
Other Intervention Name(s)
Human Rabies Immune Globulin produced by Thai Red Cross
Intervention Description
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Primary Outcome Measure Information:
Title
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
Description
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.
Time Frame
Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period
Secondary Outcome Measure Information:
Title
Number of participants who have Rabies Neutralizing antibody titers above protective levels.
Description
Number of participants who have Rabies Neutralizing antibody titers above protective levels (> 0.5 IU/mL as recommended by WHO)at 3-month period.
Time Frame
Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteers age 18-60 years. Exclusion Criteria: received prior rabies immunization pregnancy immunocompromised conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, M.D.
Organizational Affiliation
Queen Saovabha Memorial Institute, Thai Red Cross Society
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Saovabha Memorial Institute, Thai Red Cross Society
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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

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