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Immune Responses to Yellow Fever Vaccine

This study is currently recruiting participants.
Verified September 2017 by Sri Edupuganti, MD MPH, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244802
First Posted: November 19, 2010
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University
November 18, 2010
November 19, 2010
September 22, 2017
November 2010
August 2020   (Final data collection date for primary outcome measure)
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. ]
This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.
Same as current
Complete list of historical versions of study NCT01244802 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Immune Responses to Yellow Fever Vaccine
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.

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
Observational
Observational Model: Other
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Blood
Non-Probability Sample
Healthy adults between the ages of 18 to 45 years or 55 or above who previously received the yellow fever vaccine
Yellow Fever Vaccine
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
August 2020
August 2020   (Final data collection date for primary outcome measure)

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)
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Shashi Nagar, RN 404-712-1370 shashi.nagar@emory.edu
United States
 
 
NCT01244802
IRB00002834
YFV-2 Cross sectional ( Other Identifier: Other )
5U19AI057266 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Sri Edupuganti, MD MPH, Emory University
Emory University
National Institutes of Health (NIH)
Study Director: Rafi Ahmed, PhD Emory University
Principal Investigator: Srilatha Edupuganti, MD Emory University
Emory University
September 2017