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Human Immune Responses to The Yellow Fever Virus Vaccine
This study is currently recruiting participants.
Verified by Emory University, June 2008
Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00694655
  Purpose

The objective of this study is to study immune memory generated against the yellow fever vaccine (YFV) in participants who recently received the YFV vaccine. Volunteers who are planning to travel to yellow fever endemic areas will be recruited into this study. Volunteers will receive the yellow fever vaccine at the Hope Clinic of Emory University or at their private health care provider's office. Blood tests will be drawn before the vaccination and at 3 visits following vaccination. The study will last approximately 3 months.


Condition Intervention
Yellow Fever
Drug: YF-VAX (yellow fever vaccine)

MedlinePlus related topics: Fever Memory
Drug Information available for: Yellow Fever Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Human Immune Responses to Yellow Fever Vaccination

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Isolation and characterization of yellow fever vaccine specific CD8 T cells during effector and memory phases [ Time Frame: Upto 3 months after vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: YF-VAX (yellow fever vaccine)
    The standard 17-D yellow fever vaccine will be given once at enrollment.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to Understand and give informed consent

    • Age 18-45 years
    • Agrees not to take any vaccines within 30 days before or 30 days after yellow fever vaccination.
    • Women of child bearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.

Exclusion Criteria:

  • Travel to or having lived in a country/area which is endemic for yellow fever.

    • History of previous yellow fever, West Nile, Dengue, St Louis encephalitis, Japanese encephalitis vaccination or infection
    • Any history of allergy to eggs, chicken or gelatin or to any previous vaccine
    • History of HIV infection, Hepatitis B or Hepatitis C infection
    • History of any chronic meci al conditions that are considered progressive (ex.diabetes, heart disease, lung disease, liver disease, kidney disease, auto immune diseases, gastrointestinal diseases and uncontrolled hypertension).
    • Use of systemic immunosuppressive medications (ex. prednisone) for 2 weeks or more in the past 3 months
    • History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that, in the opinion of the investigator, would preclude compliance with the trial.
    • Recept of any live or inactivated vaccine within 30 eays of a vaccination visit.
    • Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland.
    • Receipt of blood products or immune globulin product within 42 days of the vaccination visit.
    • Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
    • Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694655

Contacts
Contact: Sri Edupuganti, MD 404-377-3719 ext 16 sedupug@emory.edu
Contact: Vickie Grimes, RN 404-377-3719 ext 11 vgrimes@emory.edu

Locations
United States, Georgia
The Hope Clinic of the Emory Vaccine Center Recruiting
Decatur, Georgia, United States, 30030
Contact: Jane M Skvarich, RN     404-377-3719 ext 19     jskvari@emory.edu    
Contact: Vickie Grimes, RN     404-377-3719 ext 11     vgrimes@emory.edu    
Sub-Investigator: Mark J Mulligan, MD            
Sub-Investigator: Rafi Ahmed, PhD            
Sub-Investigator: Rama Akondy, PhD            
Sub-Investigator: Carlos del Rio, MD            
Sub-Investigator: Walter Orenstein, MD            
Sub-Investigator: Kimberly Workowski, MD            
Sponsors and Collaborators
Emory University
Investigators
Study Chair: Rafi Ahmed, PhD Emory University
Principal Investigator: Sri Edupuganti, MD, MPH Emory University
  More Information

website for vaccine research clinic  This link exits the ClinicalTrials.gov site

Responsible Party: Emory University ( Srilatha Edupuganti MD )
Study ID Numbers: YFV/Human Immune Responses
Study First Received: May 19, 2008
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00694655  
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Yellow Fever
Vaccine
Immunity
yellow fever vaccine
CD8 T cell responses

Study placed in the following topic categories:
Virus Diseases
Fever
Signs and Symptoms
Yellow Fever
Yellow fever
Arbovirus Infections

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Body Temperature Changes

ClinicalTrials.gov processed this record on January 16, 2009