NCT01610362

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Queen Saovabha Memorial Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Human Rabies Immune Globulin	HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0

Timeline

• Start date: 2012-06-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2012-06-04
• Last updated: 2018-04-09

Locations

1 site across 1 country: Thailand