Immune Responses to Yellow Fever Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University
ClinicalTrials.gov Identifier:
NCT01244802
First received: November 18, 2010
Last updated: May 22, 2014
Last verified: May 2014

November 18, 2010
May 22, 2014
November 2010
December 2015   (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. ] [ Designated as safety issue: No ]
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
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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 blood draw. Approximately 120 ml of blood (8 tablespoons) will be collected during the first (and only) visit.

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Observational
Time Perspective: Cross-Sectional
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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

Prior Receipt of Yellow Fever Vaccine
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  • Group 1: 18 to 45 years of age
  • Group 2: 55 years of age and above
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2019
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Able to understand and give informed consent
  2. Age 18-45 years (Group 1) or 55 years and above (group 2) at the time of yellow fever vaccination
  3. Documentation (international certificate of vaccination (yellow card) or medical record) indicating receipt of yellow fever vaccine.

Exclusion Criteria:

  • 1. Recipient of any vaccines within 30 days before the study visit (not applicable to older adults) 2. History of a progressive and severe chronic medical condition resulting in impaired immunity (such as diabetes, kidney or liver dysfunction) 3. Required use of immunosuppressive medications 4. Reporting HIV, Hepatitis B (surface antigen positive) or Hepatitis C infections (antibody positive) on the medical/health history form 5. Recipient of a blood product or immune globulin product within 42 days of study visit 6. Reporting pregnancy
Both
18 Years and older
Yes
Contact: Shashi Nagar, RN 404-712-1370 shashi.nagar@emory.edu
Contact: Vickie Grimes, RN 404-712-1404 vgrimes@emory.edu
United States
 
NCT01244802
IRB00002834, YFV-2 Cross sectional
No
Sri Edupuganti, MD MPH, Emory University
Emory University
Not Provided
Study Director: Rafi Ahmed, PhD Emory University
Principal Investigator: Srilatha Edupuganti, MD Emory University
Emory University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP