Immunological Tolerance After Frequent Rabies Booster Vaccinations

NCT ID: NCT03729102

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-04

Study Completion Date

2023-12-31

Brief Summary

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To study immunological tolerance effect after frequent rabies booster vaccination

Detailed Description

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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.

Conditions

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Rabies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Control group

Persons who had received primary immunization

Group Type ACTIVE_COMPARATOR

Blood drawn after rabies vaccine booster vaccination

Intervention Type 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

Study group

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

Group Type EXPERIMENTAL

Blood drawn after rabies vaccine booster vaccination

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Saovabha Memorial Institute

OTHER

Sponsor Role lead

Responsible Party

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Suda Sibunruang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suda Sibunruang, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Saovabha Memorial Institute

Locations

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Queen Saovabha Memorial Institute

Pathum Wan, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Suda Sibunruang, MD

Role: CONTACT

+66 2 2520161 ext. 125

Terapong Tantawichien, MD

Role: CONTACT

+66 2 2520161 ext. 125

Facility Contacts

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Suda Punrin, MD

Role: primary

+66 2 2520161 ext. 125

Terapong Tantawichien, MD

Role: backup

+66 2 2520161 ext. 132

Other Identifiers

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QSMI-IRB 2/2018

Identifier Type: -

Identifier Source: org_study_id

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