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NCT03524417 Clinical Trial

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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03524417
Other study ID # 2/2017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 30, 2018
Est. completion date December 30, 2023

Study information
Verified date April 2022
Source Queen Saovabha Memorial Institute
Contact Suda Sibunruang, MD
Phone +66 2 2520161
Email sudapunrin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• 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.

Locations
Country Name City State
Thailand Queen Saovabha Memorial Institute, Thai Red Cross Society Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Queen Saovabha Memorial Institute

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rabies neutralizing antibody titers Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs) Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
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