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Enrolling by invitation NCT01244802

Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

Observational Yellow Fever Vaccine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Yellow Fever Vaccine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • The Hope clinic of Emory Vaccine Center — Decatur

Identifiers

NCT: NCT01244802 · IRB00002834 · U19AI057266

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗