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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2023-12-30

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).

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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.

Conditions

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Rabies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RIG injection

RIG injection on day 7

Group Type EXPERIMENTAL

Equine rabies immunoglobulin injection on day 7

Intervention Type BIOLOGICAL

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.

Interventions

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Equine rabies immunoglobulin injection on day 7

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.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes