Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
1 other identifier
interventional
50
1 country
1
Brief Summary
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Longer than P75 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
May 29, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 4, 2012
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 9, 2018
April 1, 2018
5.8 years
May 29, 2012
April 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg would be determined on day 0,14, 28 and 90. 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 3 - month period
Secondary Outcomes (1)
Number of participants who have Rabies Neutralizing antibody titers above protective levels.
Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..
Study Arms (2)
5-dose IM rabies vaccines, HRIG 20 IU/kg
ACTIVE COMPARATORRabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg
5-dose IM rabies vaccines, HRIG 40 IU/kg
EXPERIMENTALHealthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg
Interventions
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers 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, Thai Red Cross Society
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suda Sibunruang, M.D.
Queen Saovabha Memorial Institute, Thai Red Cross Society
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 29, 2012
First Posted
June 4, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 9, 2018
Record last verified: 2018-04