Human Immune Responses to The Yellow Fever Virus Vaccine - Tabular View

Tracking Information

First Received Date ^ICMJE

May 19, 2008

Last Updated Date

March 17, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00694655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Human Immune Responses to The Yellow Fever Virus Vaccine

Official Title ^ICMJE

Human Immune Responses to Yellow Fever Vaccination

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Yellow Fever

Intervention ^ICMJE

Drug: YF-VAX (yellow fever vaccine)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00694655

Responsible Party

Srilatha Edupuganti MD, Emory University

Study ID Numbers ^ICMJE

YFV/Human Immune Responses

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Emory University

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP