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NCT02547727 Clinical Trial

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

Rabies Clinical Trial

Official title:
Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02547727
Other study ID # 495/2015
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date December 2023

Study information
Verified date April 2022
Source Queen Saovabha Memorial Institute
Contact Suda Sibunruang, MD
Phone +66 81 7366076
Email sudapunrin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• rabies vaccine
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.

Locations
Country Name City State
Thailand Queen Saovabha Memorial Institute, Thai Red Cross Society Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Queen Saovabha Memorial Institute Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Specific T cell response 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
Secondary Cytokines assessment A few cytokines levels are measured by multiplex bead array assay Change from baseline of cytokines levels at 1 week
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