Human Immune Responses to The Yellow Fever Virus Vaccine - Full Text View

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

ChemIDplus related topics:

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:

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
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 August 29, 2008

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00694655