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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

About this trial

This is an interventional treatment trial for Rabies focused on measuring rabies vaccination

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

sudapunrin@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Terapong Tantawichien, MD

Phone

+66 2 2520161

Ext

125

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

sudapunrin@gmail.com

First Name & Middle Initial & Last Name & Degree

Terapong Tantawichien, MD

Phone

+66 2 2520161

Ext

132

terapong_tantawichien@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Immunological Tolerance After Frequent Rabies Booster Vaccinations

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