Clinical trial NCT01137045: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rabies
Keywords: rabies vaccine
vero cells
serology
safety
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 210
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)
timeFrame: 32 months
Secondary outcomes:
measure: safety
timeFrame: 32 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Suda Sibunruang
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Terapong Tantawichien, MD.,Prof
role: PRINCIPAL_INVESTIGATOR
References: