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

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ClinicalTrials.gov Identifier: NCT01137045
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, 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.

Condition or disease Intervention/treatment Phase
Rabies Biological: SPEEDA and TRCS SPEEDA Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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
Study Start Date : June 2010
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
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




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



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137045


Locations
Thailand
Suda Sibunruang
Bangkok, Thailand, 10130
Queen Saovabha Memorial Institute
Bangkok, Thailand, 10330
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Terapong Tantawichien, MD.,Prof Queen Saovabha Memorial Institute

Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01137045     History of Changes
Other Study ID Numbers: RC5301
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs