Immunological Tolerance After Frequent Rabies Booster Vaccinations

To study immunological tolerance effect after frequent rabies booster vaccination

Study Overview

• Status: Recruiting
• Conditions: Rabies
• Intervention / Treatment: Biological: Blood drawn after rabies vaccine 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suda Sibunruang, MD; Phone Number: 125 +66 2 2520161; Email: sudapunrin@gmail.com
• Study Contact Backup: Name: Terapong Tantawichien, MD; Phone Number: 125 +66 2 2520161; Email: terapong_tantawichien@hotmail.com

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Recruiting
      • Queen Saovabha Memorial Institute
      • Contact: Terapong Tantawichien, MD; Phone Number: 132 +66 2 2520161; Email: terapong_tantawichien@hotmail.com
      • Contact: Suda Punrin, MD; Phone Number: 125 +66 2 2520161; Email: sudapunrin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Persons who had received primary immunization	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
Experimental: Study group; Persons who had received primary immunization and later received booster vaccination for at least 3 times	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Queen Saovabha Memorial Institute
• Investigators: Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: rabies vaccination
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Rhabdoviridae Infections; Rabies
• Other Study ID Numbers: QSMI-IRB 2/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No