NCT01641315

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Queen Saovabha Memorial Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 description

* 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.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	rabies vaccine	Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2012-07-16
• Last updated: 2018-04-06

Locations

1 site across 1 country: Thailand