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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Queen Saovabha Memorial Institute.
Recruitment status was  Recruiting
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

June 3, 2010
May 30, 2012
June 2010
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01137045 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Rabies
  • Vaccine
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
    35 healthy volunteers
    Intervention: Biological: SPEEDA and TRCS SPEEDA
  • Active Comparator: VERORAB with modified TRC-ID regimen
    35 healthy volunteers
    Intervention: Biological: SPEEDA and TRCS SPEEDA
  • Active Comparator: SPEEDA with modified TRC-ID regimen plus ERIG
    35 healthy volunteers
    Intervention: Biological: SPEEDA and TRCS SPEEDA
  • Active Comparator: VERORAB with modified TRC-ID regimen plus ERIG
    35 WHO category III patients
    Intervention: Biological: SPEEDA and TRCS SPEEDA
  • Active Comparator: SPEEDA with ESSEN IM regimen plus ERIG
    35 healthy volunteers
    Intervention: Biological: SPEEDA and TRCS SPEEDA
  • Active Comparator: TRCS SPEEDA with modified TRC-ID regimen plus ERIG
    35 healthy volunteers
    Intervention: Biological: SPEEDA and TRCS SPEEDA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
15 Years to 60 Years
Yes
Contact: Suda Sibunruang, M.D. +66 1 7366076 sudapunrin@gmail.com
Contact: Terapong Tantawichien, M.D., Prof. +66 1 7350654 terapong_tantawichien@hotmail.com
Thailand
 
NCT01137045
RC5301
Yes
Suda Sibunruang, Queen Saovabha Memorial Institute
Queen Saovabha Memorial Institute
Not Provided
Principal Investigator: Terapong Tantawichien, MD.,Prof Queen Saovabha Memorial Institute
Queen Saovabha Memorial Institute
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP