Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

NCT01244802 | Enrolling By Invitation

• 2 other identifiers: IRB00002834U19AI057266
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Yellow Fever Vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Hope clinic of Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Rafi Ahmed, PhD

  Emory University

  STUDY CHAIR

• Srilatha Edupuganti, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)