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Immunological Tolerance After Frequent Rabies Booster Vaccinations

Immunological Tolerance After Frequent Rabies Booster Vaccinations

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03729102
Enrollment
60
Registered
2018-11-02
Start date
2020-06-04
Completion date
2023-12-31
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Keywords

rabies vaccination

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.

Interventions

BIOLOGICALBlood 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

Sponsors

Queen Saovabha Memorial Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rabies specific regulatory T cellsChange 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 armsRabies specific regulatory T cells are measured by flow cytometry method
Rabies specific regulatory B cellsChange 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 armsRabies specific regulatory B cells are measured by flow cytometry method
Rabies specific T follicular helper cellsChange 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 armsRabies specific T follicular helper cells are measured by flow cytometry method

Secondary

MeasureTime frameDescription
Rabies Neutralizing Antibody Titers (RNab)before (baseline) and one month after receipt of rabies booster vaccinationRabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)

Other

MeasureTime frameDescription
CytokinesChange 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 armsCytokines i.e., IL-10, TGF-Beta are measured by ELISA

Countries

Thailand

Contacts

Primary ContactSuda Sibunruang, MD
sudapunrin@gmail.com+66 2 2520161
Backup ContactTerapong Tantawichien, MD
terapong_tantawichien@hotmail.com+66 2 2520161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026