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
1 other identifier
interventional
210
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2010
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 6, 2018
April 1, 2018
7.8 years
June 3, 2010
April 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)
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.
32 months
Secondary Outcomes (1)
safety
32 months
Study Arms (6)
SPEEDA with modified TRC-ID regimen
ACTIVE COMPARATOR35 healthy volunteers
VERORAB with modified TRC-ID regimen
ACTIVE COMPARATOR35 healthy volunteers
SPEEDA with modified TRC-ID regimen plus ERIG
ACTIVE COMPARATOR35 healthy volunteers
VERORAB with modified TRC-ID regimen plus ERIG
ACTIVE COMPARATOR35 WHO category III patients
SPEEDA with ESSEN IM regimen plus ERIG
ACTIVE COMPARATOR35 healthy volunteers
TRCS SPEEDA with modified TRC-ID regimen plus ERIG
ACTIVE COMPARATOR35 healthy volunteers
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Suda Sibunruang
Bangkok, 10130, Thailand
Queen Saovabha Memorial Institute
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terapong Tantawichien, MD.,Prof
Queen Saovabha Memorial Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
June 3, 2010
First Posted
June 4, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 6, 2018
Record last verified: 2018-04