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

Rabies Clinical Trial

Official title:

An Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine(SPEEDA/TRCS SPEEDA) and Rabies Immunoglobulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137045
• Other study ID #: RC5301
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2010
• Last updated: April 5, 2018
• Start date: June 2010
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Queen Saovabha Memorial Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• SPEEDA and TRCS SPEEDA
For modified TRC-ID regimen,0.1 ml of SPEEDA, TRCS SPEEDA or VERORAB will be given at each of two sites,intradermally on upper arms on days 0,3,7 and 28. For ESSEN regimen, 1 vial of SPEEDA will be given intramuscularly at upper arm on days 0,3,7,14 and 28. For ERIG,it would be given in a single dose 40 IU/Kg at the same time as the first dose of vaccine. ERIG will be infiltrated around and into all wounds as recommended by WHO for patients in group IV and injected intramuscular at each of both gluteal areas for participants in group III,V,VI

Locations

Country	Name	City	State
Thailand	Queen Saovabha Memorial Institute	Bangkok
Thailand	Suda Sibunruang	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	immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)	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.	32 months
Secondary	safety	This would based on general examination, local examination and subjective evaluation of both solicited and unsolicited adverse events.	32 months