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

This study is currently recruiting participants.
Verified May 2012 by Queen Saovabha Memorial Institute
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier:
NCT01137045
First received: June 3, 2010
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Rabies
Vaccine
Biological: SPEEDA and TRCS SPEEDA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Queen Saovabha Memorial Institute:

Primary Outcome Measures:
  • immunogenicity (the level of rabies neutralizing antibodies by RFFIT test) [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
    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:
  • safety [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
    This would based on general examination, local examination and subjective evaluation of both solicited and unsolicited adverse events.


Estimated Enrollment: 210
Study Start Date: June 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SPEEDA with modified TRC-ID regimen
35 healthy volunteers
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

Other Names:
  • SPEEDA
  • TRCS SPEEDA
Active Comparator: VERORAB with modified TRC-ID regimen
35 healthy volunteers
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

Other Names:
  • SPEEDA
  • TRCS SPEEDA
Active Comparator: SPEEDA with modified TRC-ID regimen plus ERIG
35 healthy volunteers
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

Other Names:
  • SPEEDA
  • TRCS SPEEDA
Active Comparator: VERORAB with modified TRC-ID regimen plus ERIG
35 WHO category III patients
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

Other Names:
  • SPEEDA
  • TRCS SPEEDA
Active Comparator: SPEEDA with ESSEN IM regimen plus ERIG
35 healthy volunteers
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

Other Names:
  • SPEEDA
  • TRCS SPEEDA
Active Comparator: TRCS SPEEDA with modified TRC-ID regimen plus ERIG
35 healthy volunteers
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

Other Names:
  • SPEEDA
  • TRCS SPEEDA

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.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137045

Contacts
Contact: Suda Sibunruang, M.D. +66 1 7366076 sudapunrin@gmail.com
Contact: Terapong Tantawichien, M.D., Prof. +66 1 7350654 terapong_tantawichien@hotmail.com

Locations
Thailand
Queen Saovabha Memorial Institute Not yet recruiting
Bangkok, Thailand, 10330
Contact: Suda Sibunruang, MD.    +66 1 7366076    sudapunrin@gmail.com   
Contact: Thanphet Tantawichien, RN    +66 1 9074652    qsmithanphet@yahoo.com   
Principal Investigator: Terapong Tantawichien, MD. Prof.         
Suda Sibunruang Recruiting
Bangkok, Thailand, 10130
Contact: Suda Sibunruang, MD    +66 2 252 0161 ext 125    sudapunrin@gmail.com   
Principal Investigator: Suda Sibunruang, MD         
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Terapong Tantawichien, MD.,Prof Queen Saovabha Memorial Institute
  More Information

No publications provided

Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01137045     History of Changes
Other Study ID Numbers: RC5301
Study First Received: June 3, 2010
Last Updated: May 30, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Queen Saovabha Memorial Institute:
rabies vaccine
vero cells
serology
safety

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014