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Immunological Tolerance After Frequent Rabies Booster Vaccinations

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ClinicalTrials.gov Identifier: NCT03729102
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

Brief Summary:
To study immunological tolerance effect after frequent rabies booster vaccination

Condition or disease Intervention/treatment Phase
Rabies Biological: Blood drawn after rabies vaccine booster vaccination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.

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.
Primary Purpose: Treatment
Official Title: Immunological Tolerance After Frequent Rabies Booster Vaccinations
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

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




Primary Outcome Measures :
  1. Rabies specific regulatory T cells [ 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 ]
    Rabies specific regulatory T cells are measured by flow cytometry method

  2. Rabies specific regulatory B cells [ 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 ]
    Rabies specific regulatory B cells are measured by flow cytometry method

  3. Rabies specific T follicular helper cells [ 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 ]
    Rabies specific T follicular helper cells are measured by flow cytometry method


Secondary Outcome Measures :
  1. Rabies Neutralizing Antibody Titers (RNab) [ Time Frame: before (baseline) and one month after receipt of rabies booster vaccination ]
    Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)


Other Outcome Measures:
  1. Cytokines [ 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 ]
    Cytokines i.e., IL-10, TGF-Beta are measured by ELISA



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729102


Contacts
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Contact: Suda Sibunruang, MD +66 2 2520161 ext 125 sudapunrin@gmail.com
Contact: Terapong Tantawichien, MD +66 2 2520161 ext 125 terapong_tantawichien@hotmail.com

Locations
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Thailand
Queen Saovabha Memorial Institute Not yet recruiting
Pathum Wan, Bangkok, Thailand, 10330
Contact: Suda Punrin, MD    +66 2 2520161 ext 125    sudapunrin@gmail.com   
Contact: Terapong Tantawichien, MD    +66 2 2520161 ext 132    terapong_tantawichien@hotmail.com   
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
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Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute

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Responsible Party: Suda Sibunruang, Principal Investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT03729102     History of Changes
Other Study ID Numbers: QSMI-IRB 2/2018
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suda Sibunruang, Queen Saovabha Memorial Institute:
rabies vaccination

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs