Back to results

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

Primary Purpose

Rabies

Status

Recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Equine rabies immunoglobulin injection on day 7

About this trial

This is an interventional treatment trial for Rabies focused on measuring Rabies immunoglobulin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

Queen Saovabha Memorial Institute, Thai Red Cross SocietyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RIG injection

Arm Description

RIG injection on day 7

Outcomes

Primary Outcome Measures

Rabies neutralizing antibody titers

Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)

Secondary Outcome Measures

Full Information

NCT ID

NCT03524417

First Posted

May 2, 2018

Last Updated

April 28, 2022

Sponsor

Queen Saovabha Memorial Institute

1. Study Identification

Unique Protocol Identification Number

NCT03524417

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2018 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen Saovabha Memorial Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rabies

Keywords

Rabies immunoglobulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RIG injection

Arm Type

Experimental

Arm Description

RIG injection on day 7

Intervention Type

Biological

Intervention Name(s)

Equine rabies immunoglobulin injection on day 7

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rabies neutralizing antibody titers

Description

Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)

Time Frame

Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suda Sibunruang, MD

Phone

+66 2 2520161

Ext

125

sudapunrin@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Terapong Tantawichien, MD

Phone

+66 2 2520161

Ext

132

terapong_tantawichien@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suda Sibunruang, MD

Organizational Affiliation

Queen Saovabha Memorial Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Saovabha Memorial Institute, Thai Red Cross Society

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suda Sibunruang, M.D.

Phone

+66 81 7366076

sudapunrin@gmail.com

First Name & Middle Initial & Last Name & Degree

Terapong Tantawichien, M.D.

Phone

+66 2 2520161

Ext

125

queensaovabha@hotmail.com

First Name & Middle Initial & Last Name & Degree

Suda Sibunruang, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs