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Human Immune Responses to The Yellow Fever Virus Vaccine

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ClinicalTrials.gov Identifier: NCT00694655
Recruitment Status : Active, not recruiting
First Posted : June 10, 2008
Last Update Posted : October 1, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University

Study Description
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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 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 or disease Intervention/treatment Phase
Yellow Fever Biological: Yellow fever vaccine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Human Immune Responses to Yellow Fever Vaccination
Study Start Date : May 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694655


Locations
United States, Georgia
The Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Rafi Ahmed, PhD Emory University
Principal Investigator: Sri Edupuganti, MD, MPH Emory University
More Information
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Additional Information:
website for vaccine research clinic  This link exits the ClinicalTrials.gov site

Responsible Party: Sri Edupuganti, MD MPH, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00694655     History of Changes
Other Study ID Numbers: IRB00009560
YFV/Human Immune Responses ( Other Identifier: Other )
5U19AI057266 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Keywords provided by Sri Edupuganti, MD MPH, 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
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs