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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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Disease Information

Descriptive Information
Brief Title † Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG
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
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 Phase 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
Primary Outcome Measure † immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)
Secondary Outcome Measure † safety
Condition † Rabies
Intervention † BiologicalSPEEDA and TRCS SPEEDA
Study Arms / Comparison Groups SPEEDA with modified TRC-ID regimen 35 healthy volunteers VERORAB with modified TRC-ID regimen 35 healthy volunteers SPEEDA with modified TRC-ID regimen plus ERIG 35 healthy volunteers VERORAB with modified TRC-ID regimen plus ERIG 35 WHO category III patients SPEEDA with ESSEN IM regimen plus ERIG 35 healthy volunteers TRCS SPEEDA with modified TRC-ID regimen plus ERIG 35 healthy volunteers
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 210
Start Date † June 2010
Completion Date December 2018
Primary Completion Date December 2018
Eligibility 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
Gender Both
Ages 15 Years - 60 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Suda Sibunruang, M.D., +66 1 7366076, sudapunrin@gmail.com
Location Countries † Thailand
Administrative Information
NCT ID † NCT01137045
Organization ID RC5301
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Queen Saovabha Memorial Institute
Collaborators ††
Investigators † Principal Investigator: Terapong Tantawichien, MD.,Prof, Queen Saovabha Memorial Institute
Information Provided By
Verification Date November 2016
First Received Date † June 3, 2010
Last Updated Date November 23, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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