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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rabies

Intervention / Treatment
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* Biological: Human Rabies Immune Globulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteers age 18-60 years. Exclusion Criteria: received prior rabies immunization pregnancy immunocompromised conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention 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<br>Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg | Biological: Human Rabies Immune Globulin<br>* HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0<br>* Other names: Human Rabies Immune Globulin produced by Thai Red Cross;|
| Experimental: 5-dose IM rabies vaccines, HRIG 40 IU/kg<br>Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg | Biological: Human Rabies Immune Globulin<br>* HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0<br>* Other names: Human Rabies Immune Globulin produced by Thai Red Cross;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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.. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabies, immunoglobulin, dosage