Human Immune Responses to The Yellow Fever Virus Vaccine

Sponsor
Emory University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00694655
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
200
1
1
211
0.9

Study Details

Study Description

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
  • Biological: Yellow fever vaccine
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
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 1, 2008
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • YF-VAX
  • Outcome Measures

    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. [Upto 12 months after vaccination]

      Compare the magnitude and quality of YFV-specific immune responses in the younger and older age groups.

    Secondary Outcome Measures

    1. Determine the signatures of innate immune responses: cytokines, chemokines, dendritic cells and microarray analyses on peripheral blood mononuclear cells [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 groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sri Edupuganti, MD MPH, Associate Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT00694655
    Other Study ID Numbers:
    • IRB00009560
    • YFV/Human Immune Responses
    • 5U19AI057266
    First Posted:
    Jun 10, 2008
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by Sri Edupuganti, MD MPH, Associate Professor, Emory University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 20, 2021