Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination
1 other identifier
interventional
33
1 country
1
Brief Summary
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Feb 2011
Typical duration for not_applicable hiv
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
January 26, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2014
CompletedNovember 18, 2015
October 1, 2015
2.8 years
January 26, 2011
April 21, 2014
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rabies Neutralizing Antibody Titers
Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year.
Day 360
Study Arms (1)
Rabies vaccines on day 0 and 3
EXPERIMENTALCell culture Rabies vaccines on day 0 and 3
Interventions
All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360
Eligibility Criteria
You may qualify if:
- HIV infected patients 18-60 years of age
- Ever received primary rabies immunization
You may not qualify if:
- currently have any active opportunistic infections
- have received blood or blood product within previous 3 months
- history of allergy to vaccine or any vaccine components
- currently received anti-malarial drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Saovabha Memorial Institute
Bangkok, Bangkok, 10330, Thailand
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small sample size heterogeneous characteristics of participants Use only CD4+ T lymphocyte counts as the only immunologic surrogate marker
Results Point of Contact
- Title
- Dr.Suda Sibunruang
- Organization
- Queen Saovabha Memorial Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Suda Sibunruang, MD
Queen Saovabha Memorial Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 26, 2011
First Posted
January 31, 2011
Study Start
February 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
November 18, 2015
Results First Posted
June 4, 2014
Record last verified: 2015-10