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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

  • 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.


Sponsor: Queen Saovabha Memorial Institute

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Queen Saovabha Memorial Institute

Dates:
Date Received: May 29, 2012
Date Started: June 2012
Date Completion: December 2018
Last Updated: November 23, 2016
Last Verified: November 2016