Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG

Phase 4

Completed

• Conditions: Rabies

• Registration Number: NCT01137045
• Lead Sponsor: Queen Saovabha Memorial Institute

Brief Summary

A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Detailed Description

Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• subjects are healthy population older than 15 years.
• subjects are willing to give signed informed consents.
• subjects are willing to give blood samples on recommended days.
• subjects are available for follow up according to the table of administration

Exclusion Criteria

• subjects who had received any type of rabies vaccination in the past
• subjects who had received rabies immunoglobulin in the past
• subjects who had known as immunocompromised hosts
• subjects on steroids or any other immunosuppressant
• subjects on concomitant antimalarials
• subjects who have received of any blood products within the previous 3 months
• subjects with history of allergy to any ingredient of the vaccine
• subjects who had known as pregnancy in first recruitment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)	32 months	The immunogenicity (Rabies neutralizing antibodies) would be checked from the blood samples for 7 times (on days 0,7,14,28,90,180 and 360)for one year duration in each phase.

Secondary Outcome Measures

Name	Time	Method
safety	32 months	This would based on general examination, local examination and subjective evaluation of both solicited and unsolicited adverse events.

Trial Locations

Locations (2)

Suda Sibunruang; 🇹🇭 Bangkok, Thailand

Queen Saovabha Memorial Institute; 🇹🇭 Bangkok, Thailand