Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
1 other identifier
interventional
75
1 country
1
Brief Summary
Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedStudy Start
First participant enrolled
September 1, 2015
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
2.6 years
July 12, 2012
April 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
Secondary Outcomes (1)
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28
Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
Study Arms (3)
Rabies vaccine, IM day 0,3,7,28 with RIG
EXPERIMENTALHealthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0.
Rabies vaccine, IM day 0,3,7,14 with RIG
EXPERIMENTALHealthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0.
Rabies vaccine, IM Day 0,3,7,14,28 with RIG
ACTIVE COMPARATORRabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0
Interventions
Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Eligibility Criteria
You may qualify if:
- healthy volunteers age 18-60 years.
You may not qualify if:
- received prior rabies immunization
- pregnancy
- immunocompromised conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Saovabha Memorial Institute
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suda Sibunruang, MD
Queen Saovabha Memorial Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 16, 2012
Study Start
September 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 6, 2018
Record last verified: 2018-04