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NCT03729102 Clinical Trial

Immunological Tolerance After Frequent Rabies Booster Vaccinations

Rabies Clinical Trial

Official title:
Immunological Tolerance After Frequent Rabies Booster Vaccinations

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03729102
Other study ID # QSMI-IRB 2/2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 4, 2020
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 immunological tolerance effect after frequent rabies booster vaccination

Description:

Previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. We study immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Healthy adults - Previously received rabies vaccination Exclusion Criteria: - Had immunocompromised conditions - Received blood or blood product within 3 months - Received anti-malarial drugs

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Blood drawn after rabies vaccine booster vaccination
All participants would be given one dose of rabies vaccine and monitor the immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cells, cytokines i.e., IL-10, TGF-Beta, and Rabies neutralizing antibody titers, before and after the booster injection

Locations
Country Name City State
Thailand Queen Saovabha Memorial Institute Pathum Wan 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 Cytokines Cytokines i.e., IL-10, TGF-Beta are measured by ELISA Change from baseline of quantitative measurement of cytokines levels would be measured before (baseline) and one month after receipt of rabies booster vaccination and compared between 2 arms
Primary Rabies specific regulatory T cells Rabies specific regulatory T cells are measured by flow cytometry method Change from baseline of numbers of Rabies specific regulatory T cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Primary Rabies specific regulatory B cells Rabies specific regulatory B cells are measured by flow cytometry method Change from baseline of numbers of Rabies specific regulatory B cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Primary Rabies specific T follicular helper cells Rabies specific T follicular helper cells are measured by flow cytometry method Change from baseline of numbers of Rabies specific T follicular helper cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Secondary Rabies Neutralizing Antibody Titers (RNab) Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs) before (baseline) and one month after receipt of rabies booster vaccination
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