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

Not Applicable

Completed

• Conditions: Rabies
• Interventions: Biological: Human Rabies Immune Globulin

• Registration Number: NCT01610362
• Lead Sponsor: Queen Saovabha Memorial Institute

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.

Study Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-30
• Study Start: 2012-06
• Study First Posted: 2012-06-04
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• healthy volunteers age 18-60 years.

Exclusion Criteria

• received prior rabies immunization
• pregnancy
• immunocompromised conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-dose IM rabies vaccines, HRIG 20 IU/kg	Human Rabies Immune Globulin	Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg
5-dose IM rabies vaccines, HRIG 40 IU/kg	Human Rabies Immune Globulin	Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants who have Rabies Neutralizing antibody titers above protective levels.	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.

Trial Locations

Locations (1)

Queen Saovabha Memorial Institute, Thai Red Cross Society; 🇹🇭 Bangkok, Thailand