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Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults

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Disease Information

Descriptive Information
Brief Title † Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults
Official Title † Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
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.
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 Phase N/A
Study Type † Interventional
Study Design † Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Rabies neutralizing antibody titers
Secondary Outcome Measure † Specific T cell response
Condition † Rabies
Intervention † Biologicalrabies vaccine
Study Arms / Comparison Groups 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. 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 40
Start Date † February 2016
Completion Date December 2018
Primary Completion Date December 2018
Eligibility Criteria † 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
Gender Both
Ages 18 Years - 60 Years
Accepts Healthy Volunteers No
Contacts †† Suda Sibunruang, MD, +66 81 7366076, sudapunrin@gmail.com
Location Countries † Thailand
Administrative Information
NCT ID † NCT02547727
Organization ID 495/2015
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Queen Saovabha Memorial Institute
Collaborators †† Chulalongkorn University
Investigators † Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university
Information Provided By
Verification Date November 2016
First Received Date † September 9, 2015
Last Updated Date November 23, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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