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Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

Sponsor
Emory University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01244802
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
300
Enrollment
1
Location
181
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to study immune memory generated against the yellow fever (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not receive vaccine shots; only immune responses to previous yellow fever vaccination will be studied. The study involves one or multiple blood draws.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The goal of this study is to characterize immune memory in humans who have previously received yellow fever vaccine. The project is designed to study the magnitude and persistence of both humoral, and cell-mediated immune memory generated post-vaccination. Since aging has an effect on the immune system (eg. decreased thymic output, replacement of hematopoietic cells in the bone marrow with adipocytes), the researchers will analyze the young adults (aged 18-45 years) and the older vaccinees (55 years or older) in separate groups.

    The specific aims of the study are to:

    • Determine the phenotypic and functional characterization of memory T cell responses to yellow fever vaccination

    • Determine neutralizing antibody titer after yellow fever vaccination

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination
    Study Start Date :
    Nov 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1: 18 to 45 years of age

    Between the ages of 18 and 45 at the time of yellow fever vaccination
    Group 2: 55 years of age and above

    Aged 55 or greater at the time of yellow fever vaccination

    Outcome Measures

    Primary Outcome Measures

    1. Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination [Immune responses will be measured from at least 30 days after yellow fever vaccination.]

      This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Able to understand and give informed consent

    • Age 18-45 years (Group 1) or 55 years and above (Group 2) at the time of yellow fever vaccination

    • Documentation (international certificate of vaccination (yellow card) or medical record) indicating receipt of yellow fever vaccine.

    Exclusion Criteria:

    • Recipient of any vaccines within 30 days before the study visit (not applicable to older adults)

    • History of a progressive and severe chronic medical condition resulting in impaired immunity (such as diabetes, kidney or liver dysfunction)

    • Required use of immunosuppressive medications

    • Reporting HIV, Hepatitis B (surface antigen positive) or Hepatitis C infections (antibody positive) on the medical/health history form

    • Recipient of a blood product or immune globulin product within 42 days of study visit

    • Reporting pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hope clinic of Emory Vaccine Center Decatur Georgia United States 30030

    Sponsors and Collaborators

    • Emory University
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: Rafi Ahmed, PhD, Emory University
    • Principal Investigator: Srilatha Edupuganti, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sri Edupuganti, MD MPH, Assistant Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT01244802
    Other Study ID Numbers:
    • IRB00002834
    • YFV Cross Sectional
    • 5U19AI057266
    First Posted:
    Nov 19, 2010
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sri Edupuganti, MD MPH, Assistant Professor, Emory University
    yellow fever vaccine
    Additional relevant MeSH terms:
    Yellow Fever
    Fever

    Study Results

    No Results Posted as of Oct 20, 2021