Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Yellow Fever Vaccine

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30030
      • The Hope Clinic of Emory Vaccine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults between the ages of 18 to 45 years or 55 or above who previously received the yellow fever vaccine

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination	This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.	Immune responses will be measured from at least 30 days after yellow fever vaccination.

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Rafi Ahmed, PhD, Emory University; Principal Investigator: Srilatha Edupuganti, MD, Emory University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: November 18, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimated): November 19, 2010

Study Record Updates

• Last Update Posted (Actual): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Body Temperature Changes; Fever; Yellow Fever
• Other Study ID Numbers: IRB00002834; U19AI057266 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No