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NCT03228069 Clinical Trial

Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults

Rabies Clinical Trial

Official title:
Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03228069
Other study ID # 1/2017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date December 2023

Study information
Verified date April 2022
Source Queen Saovabha Memorial Institute
Contact Suda Sibunruang, MD
Phone +66 2 2520161
Email sudapunrin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before

Description:

Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .

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 65 Years
Eligibility Inclusion Criteria: - Healthy HIV-infected adults - Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators. Exclusion Criteria: - Have any active opportunistic infections - Received blood or blood product within 3 months - Received anti-malarial drugs - Received rabies vaccination in a previous year.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood drawn after rabies booster vaccination
Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.

Locations
Country Name City State
Thailand Queen Saovabha Memorial Institute Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Queen Saovabha Memorial Institute

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Other Rabies specific regulatory T cells Rabies specific regulatory T cells is measured by flow cytometry method Numbers of Rabies specific regulatory T cells after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Primary Rabies Neutralizing Antibody Titers (RNab) Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs) GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Secondary Rabies specific T cell response Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT) Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
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