Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults
Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
1 other identifier
interventional
40
1 country
1
Brief Summary
A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies 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 P25-P50 for not_applicable
Started Feb 2016
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
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 29, 2022
April 1, 2022
7.8 years
September 9, 2015
April 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rabies neutralizing antibody titers
Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)
Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
Secondary Outcomes (2)
Specific T cell response
Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
Cytokines assessment
Change from baseline of cytokines levels at 1 week
Study Arms (2)
Four-site intradermal vaccination
EXPERIMENTAL0.1 ml of rabies vaccine is distributed to 4 sites over both arms and thigh intradermally on day 0. Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
Intramuscular vaccination
ACTIVE COMPARATOR0.5 ml of rabies vaccine is injected to one arm on day 0 and 3.Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
Interventions
Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
Eligibility Criteria
You may qualify if:
- HIV infected patients
- Age 18 - 60 years
- Received primary rabies immunization
You may not qualify if:
- Have any active opportunistic infections
- Received blood or blood product within 3 months
- Allergy to vaccine or any vaccine components
- Received anti-malarial drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen Saovabha Memorial Institutelead
- Chulalongkorn Universitycollaborator
Study Sites (1)
Queen Saovabha Memorial Institute, Thai Red Cross Society
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suda Sibunruang, MD
Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 11, 2015
Study Start
February 1, 2016
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
April 29, 2022
Record last verified: 2022-04