- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02547727
Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults
April 28, 2022 updated by: Suda Sibunruang, Queen Saovabha Memorial Institute
Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
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.
Study Overview
Detailed Description
A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons.
So, the investigators hypothesized the same outcome in HIV - infected patients.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Suda Sibunruang, MD
- Phone Number: +66 81 7366076
- Email: sudapunrin@gmail.com
Study Contact Backup
- Name: Terapong Tantawichien, MD
- Phone Number: +66 81 7350654
- Email: terapong_tantawichien@hotmail.com
Study Locations
-
-
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Bangkok, Thailand, 10330
- Recruiting
- Queen Saovabha Memorial Institute, Thai Red Cross Society
-
Contact:
- Suda Sibunruang, M.D.
- Phone Number: +66 81 7366076
- Email: sudapunrin@gmail.com
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Contact:
- Terapong Tantawichien, M.D.
- Phone Number: 125 +66 2 2520161
- Email: queensaovabha@hotmail.com
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Principal Investigator:
- Suda Sibunruang, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HIV infected patients
- Age 18 - 60 years
- Received primary rabies immunization
Exclusion Criteria:
- Have any active opportunistic infections
- Received blood or blood product within 3 months
- Allergy to vaccine or any vaccine components
- Received anti-malarial drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Four-site intradermal vaccination
0.1 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.
|
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.
|
Active Comparator: Intramuscular vaccination
0.5 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rabies neutralizing antibody titers
Time Frame: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific T cell response
Time Frame: Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
|
Specific T cell response is measured by OX-40 assay
|
Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
|
Cytokines assessment
Time Frame: Change from baseline of cytokines levels at 1 week
|
A few cytokines levels are measured by multiplex bead array assay
|
Change from baseline of cytokines levels at 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
September 9, 2015
First Submitted That Met QC Criteria
September 10, 2015
First Posted (Estimate)
September 11, 2015
Study Record Updates
Last Update Posted (Actual)
April 29, 2022
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 495/2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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