Immunological Tolerance After Frequent Rabies Booster Vaccinations

NCT03729102 | Unknown

• 1 other identifier: QSMI-IRB 2/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To study immunological tolerance effect after frequent rabies booster vaccination

Conditions

Rabies

Keywords

rabies vaccination

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Rabies Neutralizing Antibody Titers (RNab)

  before (baseline) and one month after receipt of rabies booster vaccination

Other Outcomes (1)

• Cytokines

  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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Persons who had received primary immunization

Biological: Blood drawn after rabies vaccine booster vaccination

Study group

EXPERIMENTAL

Persons who had received primary immunization and later received booster vaccination for at least 3 times

Biological: Blood drawn after rabies vaccine booster vaccination

Interventions

Blood drawn after rabies vaccine booster vaccination BIOLOGICAL

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

Control group; Study group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults
• Previously received rabies vaccination

You may not qualify if:

• Had immunocompromised conditions
• Received blood or blood product within 3 months
• Received anti-malarial drugs

Sponsors & Collaborators

• Queen Saovabha Memorial Institute: lead

Study Sites (1)

Queen Saovabha Memorial Institute

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Suda Sibunruang, MD

  Queen Saovabha Memorial Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suda Sibunruang, MD

CONTACT

+66 2 2520161; sudapunrin@gmail.com

Terapong Tantawichien, MD

CONTACT

+66 2 2520161; terapong_tantawichien@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 2, 2018
• Study Start: June 4, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)