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

Not Applicable

• Conditions: Rabies
• Interventions: Biological: Equine rabies immunoglobulin injection on day 7

• Registration Number: NCT03524417
• Lead Sponsor: Queen Saovabha Memorial Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-14
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RIG injection	Equine rabies immunoglobulin injection on day 7	RIG injection on day 7

Primary Outcome Measures

Name	Time	Method
Rabies neutralizing antibody titers	Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks	Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)

Trial Locations

Locations (1)

Queen Saovabha Memorial Institute, Thai Red Cross Society; 🇹🇭 Bangkok, Thailand