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

Sponsor:	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 upto 8 visits following vaccination. A volunteers's study participation may will last as short as 1 month or as long as one year depending on the immune responses.

We plan to compare the immune responses in younger people (18 to 45 years) to that of older people (55 or above).

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Human Immune Responses to Yellow Fever Vaccination

Resource links provided by NLM:

MedlinePlus related topics: Fever Memory

Drug Information available for: Yellow Fever Vaccine

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

1. Isolation and characterization of yellow fever vaccine (YFV-17D) specific adaptive immune responses: characterize the magnitude and quality of YFV specific T cell responses, antibody secreting cells and memory B cells. [ Time Frame: Upto 12 months after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the signatures of innate immune responses: cytokines, chemokines, dendritic cells and microarray analyses on peripheral blood mononuclear cells [ Time Frame: Upto 12 months after vaccination ] [ Designated as safety issue: No ]
Compare the magnitude and kinetics of T and B cell responses, antibody secreting cells and memory B cells in the younger and the older age group

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (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 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Able to understand and give informed consent
Age 18-45 years or greater than or equal to 55 years
If possible, participants agree 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
A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
History of HIV infection, Hepatitis B or Hepatitis C infection
History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, 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
Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder.
Recipient of a 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	404-712-1370	sedupug@emory.edu
Contact: Beverly Weaver, RN	404-712-1457	bweaver@emory.edu

Locations

United States, Georgia
The Hope Clinic of the Emory Vaccine Center	Recruiting
Decatur, Georgia, United States, 30030
Contact: Bill Emery, RN 404-712-1408 bill.emery@emory.edu
Contact: Vickie Grimes, RN 404-712-1404 vgrimes@emory.edu
Sub-Investigator: Mark J Mulligan, MD
Sub-Investigator: Rafi Ahmed, PhD
Sub-Investigator: Rama Akondy, PhD

Sponsors and Collaborators

Emory University

Investigators

Study Chair:	Rafi Ahmed, PhD	Emory University
Principal Investigator:	Sri Edupuganti, MD, MPH	Emory University

More Information

Additional Information:

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

No publications provided

Responsible Party:	Srilatha Edupuganti MD, Emory University
ClinicalTrials.gov Identifier:	NCT00694655 History of Changes
Other Study ID Numbers:	YFV/Human Immune Responses
Study First Received:	May 19, 2008
Last Updated:	February 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Yellow Fever
Vaccine
Immunity
yellow fever vaccine
CD8 T cell responses

Additional relevant MeSH terms:

Fever
Yellow Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections

Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on February 12, 2012