Immunological Tolerance After Frequent Rabies Booster Vaccinations
Primary Purpose
Rabies
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Blood drawn after rabies vaccine booster vaccination
Sponsored by
About this trial
This is an interventional treatment trial for Rabies focused on measuring rabies vaccination
Eligibility Criteria
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
Sites / Locations
- Queen Saovabha Memorial InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Study group
Arm Description
Persons who had received primary immunization
Persons who had received primary immunization and later received booster vaccination for at least 3 times
Outcomes
Primary Outcome Measures
Rabies specific regulatory T cells
Rabies specific regulatory T cells are measured by flow cytometry method
Rabies specific regulatory B cells
Rabies specific regulatory B cells are measured by flow cytometry method
Rabies specific T follicular helper cells
Rabies specific T follicular helper cells are measured by flow cytometry method
Secondary Outcome Measures
Rabies Neutralizing Antibody Titers (RNab)
Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)
Full Information
NCT ID
NCT03729102
First Posted
October 30, 2018
Last Updated
April 28, 2022
Sponsor
Queen Saovabha Memorial Institute
1. Study Identification
Unique Protocol Identification Number
NCT03729102
Brief Title
Immunological Tolerance After Frequent Rabies Booster Vaccinations
Official Title
Immunological Tolerance After Frequent Rabies Booster Vaccinations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Saovabha Memorial Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study immunological tolerance effect after frequent rabies booster vaccination
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
rabies vaccination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There would be two study groups. Those who had received primary immunization would be the control group. While persons who had received primary immunization and later received booster vaccination for at least 3 times would be the study group.
All participants would be given one dose of rabies vaccine and monitored the immunological cells and cytokines before and after the rabies booster injection.
Masking
Outcomes Assessor
Masking Description
The serum samples from all participants would be labelled as the codes, of which the laboratory technicians could not access to the groups or other details of the participants.
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Persons who had received primary immunization
Arm Title
Study group
Arm Type
Experimental
Arm Description
Persons who had received primary immunization and later received booster vaccination for at least 3 times
Intervention Type
Biological
Intervention Name(s)
Blood drawn after rabies vaccine booster vaccination
Intervention Description
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
Primary Outcome Measure Information:
Title
Rabies specific regulatory T cells
Description
Rabies specific regulatory T cells are measured by flow cytometry method
Time Frame
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
Title
Rabies specific regulatory B cells
Description
Rabies specific regulatory B cells are measured by flow cytometry method
Time Frame
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
Title
Rabies specific T follicular helper cells
Description
Rabies specific T follicular helper cells are measured by flow cytometry method
Time Frame
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 Outcome Measure Information:
Title
Rabies Neutralizing Antibody Titers (RNab)
Description
Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)
Time Frame
before (baseline) and one month after receipt of rabies booster vaccination
Other Pre-specified Outcome Measures:
Title
Cytokines
Description
Cytokines i.e., IL-10, TGF-Beta are measured by ELISA
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suda Sibunruang, MD
Phone
+66 2 2520161
Ext
125
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Terapong Tantawichien, MD
Phone
+66 2 2520161
Ext
125
Email
terapong_tantawichien@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, MD
Organizational Affiliation
Queen Saovabha Memorial Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Saovabha Memorial Institute
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suda Punrin, MD
Phone
+66 2 2520161
Ext
125
Email
sudapunrin@gmail.com
First Name & Middle Initial & Last Name & Degree
Terapong Tantawichien, MD
Phone
+66 2 2520161
Ext
132
Email
terapong_tantawichien@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Immunological Tolerance After Frequent Rabies Booster Vaccinations
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