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
  Purpose

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.


Condition
Prior Receipt of Yellow Fever Vaccine

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

Resource links provided by NLM:


Further study details as provided by Emory University:

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. ] [ Designated as safety issue: No ]
    This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.


Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1: 18 to 45 years of age
Group 2: 55 years of age and above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244802

Contacts
Contact: Shashi Nagar, RN 404-712-1370 shashi.nagar@emory.edu
Contact: Vickie Grimes, RN 404-712-1404 vgrimes@emory.edu

Locations
United States, Georgia
The Hope clinic of Emory Vaccine Center Recruiting
Decatur, Georgia, United States, 30030
Contact: Sashi Nagar       shashi.nagar@emory.edu   
Principal Investigator: Srilatha Edupuganti, MD         
Sponsors and Collaborators
Emory University
Investigators
Study Director: Rafi Ahmed, PhD Emory University
Principal Investigator: Srilatha Edupuganti, MD Emory University
  More Information

No publications provided

Responsible Party: Sri Edupuganti, MD MPH, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01244802     History of Changes
Other Study ID Numbers: IRB00002834, YFV-2 Cross sectional
Study First Received: November 18, 2010
Last Updated: May 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Emory University:
yellow fever vaccine

Additional relevant MeSH terms:
Fever
Yellow Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on August 28, 2014