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
Sponsored by
About this trial
This is an interventional treatment trial for Rabies focused on measuring Rabies immunoglobulin
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Terapong Tantawichien, MD
Phone
+66 2 2520161
Ext
132
Email
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
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name & Degree
Terapong Tantawichien, M.D.
Phone
+66 2 2520161
Ext
125
Email
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
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