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

NCT03524417 | Unknown

• 1 other identifier: 2/2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Rabies

Keywords

Rabies immunoglobulin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RIG injection

EXPERIMENTAL

RIG injection on day 7

Biological: Equine rabies immunoglobulin injection on day 7

Interventions

Equine rabies immunoglobulin injection on day 7 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.

RIG injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 60 years
• WHO category III rabies exposure
• Received rabies vaccination on day 0 and 3.

You may not qualify if:

• Received RIG
• Immunocompromised hosts or receiving immunosuppressive therapy
• Received blood or blood product within 3 months
• Received anti-malarial drugs

Sponsors & Collaborators

• Queen Saovabha Memorial Institute: lead

Study Sites (1)

Queen Saovabha Memorial Institute, Thai Red Cross Society

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Suda Sibunruang, MD

  Queen Saovabha Memorial Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suda Sibunruang, MD

CONTACT

+66 2 2520161; sudapunrin@gmail.com

Terapong Tantawichien, MD

CONTACT

+66 2 2520161; terapong_tantawichien@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 14, 2018
• Study Start: April 30, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

TH (1)