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
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-
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Bangkok, Thailand, 10330
- Queen Saovabha Memorial Institute, Thai Red Cross Society
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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
|
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Other Names:
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Experimental: 5-dose IM rabies vaccines, HRIG 40 IU/kg
Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg
|
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
Other Names:
|
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..
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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