Human Immune Responses to The Yellow Fever Virus Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University
ClinicalTrials.gov Identifier:
NCT00694655
First received: May 19, 2008
Last updated: May 22, 2014
Last verified: May 2014
  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
Biological: Yellow fever vaccine

Study Type: Interventional
Study Design: 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:


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: 200
Study Start Date: May 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
vaccine
There are no arms for this study. All participants will receive the YFV vaccine if they meet the screening criteria.
Biological: Yellow fever vaccine
YFV will be given as injection
Other Name: YF-VAX

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to understand and give informed consent
  2. Age 18-45 years or greater than or equal to 55 years
  3. If possible, participants agree not to take any vaccines within 30 days before or 30 days after yellow fever vaccination
  4. 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:

  1. Travel to or having lived in a country/area which is endemic for yellow fever
  2. History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, Japanese encephalitis vaccination or infection
  3. Any history of allergy to eggs, chicken or gelatin or to any previous vaccine
  4. 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.
  5. History of HIV infection, Hepatitis B or Hepatitis C infection
  6. 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
  7. 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
  8. Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder.
  9. Recipient of a blood products or immune globulin product within 42 days of the vaccination visit
  10. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration
  11. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694655

Contacts
Contact: Shashi Nagar, MA 404-712-1407 shashi.nagar@emory.edu
Contact: Srilatha Edupuganti 404-712-1370 sedupug@emory.edu

Locations
United States, Georgia
The Hope Clinic of the Emory Vaccine Center Recruiting
Decatur, Georgia, United States, 30030
Contact: Eileen Oskinski    404-712-1371    gosinsk@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:
No publications provided

Responsible Party: Sri Edupuganti, MD MPH, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00694655     History of Changes
Other Study ID Numbers: IRB00009560, YFV/Human Immune Responses
Study First Received: May 19, 2008
Last Updated: May 22, 2014
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
Arbovirus Infections
Body Temperature Changes
Flaviviridae Infections
Flavivirus Infections
Hemorrhagic Fevers, Viral
RNA Virus Infections
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014