Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Human Immune Responses to The Yellow Fever Virus Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00694655
Recruitment Status : Active, not recruiting
First Posted : June 10, 2008
Last Update Posted : October 20, 2021
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 2008
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Vaccines

Arm Intervention/treatment
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

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 ]
    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 [ 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 groups.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00694655

Layout table for location information
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)
Layout table for investigator information
Study Chair: Rafi Ahmed, PhD Emory University
Principal Investigator: Sri Edupuganti, MD, MPH Emory University
Additional Information:
Layout table for additonal information
Responsible Party: Sri Edupuganti, MD MPH, Associate Professor, Emory University Identifier: NCT00694655    
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 20, 2021
Last Verified: October 2021
Keywords provided by Sri Edupuganti, MD MPH, Emory University:
Yellow Fever
yellow fever vaccine
CD8 T cell responses
Additional relevant MeSH terms:
Layout table for MeSH terms
Yellow Fever
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral