Human Immune Responses to The Yellow Fever Virus Vaccine

Condition(s) targeted: Yellow Fever

Intervention: YF-VAX (yellow fever vaccine) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Rafi Ahmed, PhD, Study Chair, Affiliation: Emory University
Sri Edupuganti, MD, MPH, Principal Investigator, Affiliation: Emory University

Overall contact:
Sri Edupuganti, MD, Phone: 404-377-3719, Ext: 16, Email: sedupug@emory.edu

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.

Official title: Human Immune Responses to Yellow Fever Vaccination

Study design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary outcome: Isolation and characterization of yellow fever vaccine specific CD8 T cells during effector and memory phases

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Sri Edupuganti, MD, Phone: 404-377-3719, Ext: 16, Email: sedupug@emory.edu

The Hope Clinic of the Emory Vaccine Center, Decatur, Georgia 30030, United States; Recruiting
Jane M Skvarich, RN, Phone: 404-377-3719, Ext: 19, Email: jskvari@emory.edu
Vickie Grimes, RN, Phone: 404-377-3719, Ext: 11, Email: vgrimes@emory.edu
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, Sub-Investigator

website for vaccine research clinic

Starting date: May 2008
Ending date: June 2012
Last updated: June 9, 2008