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

Queen Saovabha Memorial Institute

Status: Enrolling

Conditions: Rabies

Treatments: Biological: Equine rabies immunoglobulin injection on day 7

Study type: Interventional

Funder types: Other

Identifiers

NCT03524417

2/2017

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RIG injection

Experimental group

Description:

RIG injection on day 7

Treatment:

Biological: Equine rabies immunoglobulin injection on day 7