Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response

Study Overview
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Brief Summary
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No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1).

Detailed Description
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Rabies immunoglobulin (RIG) should be administered as soon as possible after the initiation of post-exposure prophylaxis. RIG should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. Nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). The ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.

Official Title
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Effect of Equine Rabies Immunoglobulin Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response

Conditions
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Rabies

Intervention / Treatment
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* Biological: Equine rabies immunoglobulin injection on day 7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 60 years WHO category III rabies exposure Received rabies vaccination on day 0 and 3. Exclusion Criteria: Received RIG Immunocompromised hosts or receiving immunosuppressive therapy Received blood or blood product within 3 months Received anti-malarial drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIG injection<br>RIG injection on day 7 | Biological: Equine rabies immunoglobulin injection on day 7<br>* The patients with WHO category III rabies exposure, who have received first dose of rabies vaccination a week before and have not received rabies immunoglobulin were enrolled. Blood for Rabies neutralizing antibody titers (RNab) would be examined on day 0. On the same day, Equine rabies immunoglobulin (ERIG) at the dosage of 40 IU/kg would be injected into and around the wound as much as possible and the rest would be injected intramuscularly at the site distance from rabies vaccine. Then blood for RNab would be serially examined on day 7, 14, 90, 365.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies neutralizing antibody titers | Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs) | Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rabies immunoglobulin