Clinical Trial: Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins

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

Official Title: Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment

Brief Summary: Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.

Detailed Summary:

  • Controlled trial study
  • All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups.

group 1 : 25 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 40 IU/kg of equine rabies immune globulin (ERIG).

group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 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 rabies vaccination on day 0,3,7,14 [ Time Frame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period ]

Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360. 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: Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28 [ Time Frame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period ]

Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7 and 28 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.


Original Secondary Outcome: Same as current

Information By: Queen Saovabha Memorial Institute

Dates:
Date Received: July 12, 2012
Date Started: September 2015
Date Completion: December 2018
Last Updated: November 23, 2016
Last Verified: November 2016