Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

NCT ID: NCT01244802

Last Updated: 2024-11-04

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

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Yellow Fever Vaccine

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1: 18 to 45 years of age

Between the ages of 18 and 45 at the time of yellow fever vaccination

No interventions assigned to this group

Group 2: 55 years of age and above

Aged 55 or greater at the time of yellow fever vaccination

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Sri Edupuganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafi Ahmed, PhD

Role: STUDY_CHAIR

Emory University

Srilatha Edupuganti, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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The Hope clinic of Emory Vaccine Center

Decatur, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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U19AI057266

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00002834

Identifier Type: -

Identifier Source: org_study_id

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