Characterization of T Cell Responses Following Yellow Fever Virus Vaccination in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Charles Rice, Rockefeller University
ClinicalTrials.gov Identifier:
NCT00616356
First received: January 23, 2008
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

The investigators at Rockefeller University are doing this research to study how the immune system responds to viruses and other infectious agents by using the yellow fever 17D vaccine as a model. The YFV-17D vaccine is one of the safest and most effective vaccines known and has been used to vaccinate humans against yellow fever virus (YFV) infection since the 1930s. By studying how the human immune system responds to the YFV vaccine we hope to learn more about the normal functioning of the immune system so that it might be possible to design new, more effective types of vaccines to prevent important infectious diseases.

The reason for doing this research is:

Currently there is very little information about which factors determine the effectiveness of the initial (primary) immune response to a foreign substance (antigen), such as a virus, that person may be exposed to. There is also very little known about what determines how effectively and for how long a person's immune system can react to the same antigen to prevent another infection. Studies in animals have given us important information about how the immune systems of other animals behave upon initial or repeated exposure to antigens,but these topics have not been studied in detail in humans.

The following hypotheses will be tested:

  • The magnitude of the initial expansion of T lymphocytes (the "clonal burst") specific for the infecting virus determines the level at which memory T cell responses are generated against the specific viral antigen and the duration of the memory T cell response generated in the body.
  • The majority of CD8 T cells generated after immunization are yellow fever specific and not "bystander activation" of non-specific cells.

Condition
Yellow Fever

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Characterization of T Cell Responses Following Yellow Fever Virus Vaccination in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Estimated Enrollment: 8
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Rockefeller University Personnel

Criteria

Inclusion Criteria:

  1. Able to give informed consent.
  2. Age 18-45 years.
  3. Agrees not to take any vaccines within 30 days before or 30 days after YFV vaccination.

Exclusion Criteria:

  1. Previously vaccinated with yellow fever vaccine.
  2. A history of a medical condition resulting in impaired immunity.
  3. Use of immunosuppressive medications.
  4. Thymus gland dysfunction.
  5. Recipient of a blood product or immune globulin product within 42 days of the screening visit or 30 days after the YFV vaccination.
  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: NCT00616356

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Emory University
Investigators
Principal Investigator: Charles M Rice, PhD Rockefeller University
  More Information

No publications provided

Responsible Party: Charles Rice, Professor, Rockefeller University
ClinicalTrials.gov Identifier: NCT00616356     History of Changes
Other Study ID Numbers: RUH IRB # CRI-0618
Study First Received: January 23, 2008
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockefeller University:
Yellow Fever

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

ClinicalTrials.gov processed this record on August 01, 2014