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Trial record 5 of 40 for:    "Yellow fever"

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

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ClinicalTrials.gov Identifier: NCT00616356
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : November 8, 2011
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Charles Rice, Rockefeller University

Tracking Information
First Submitted Date January 23, 2008
First Posted Date February 15, 2008
Last Update Posted Date November 8, 2011
Study Start Date December 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00616356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of T Cell Responses Following Yellow Fever Virus Vaccination in Healthy Adults
Official Title Characterization of T Cell Responses Following Yellow Fever Virus Vaccination in Healthy Adults
Brief Summary

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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Rockefeller University Personnel
Condition Yellow Fever
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February¬†14,¬†2008)
8
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00616356
Other Study ID Numbers RUH IRB # CRI-0618
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Charles Rice, Rockefeller University
Study Sponsor Rockefeller University
Collaborators Emory University
Investigators
Principal Investigator: Charles M Rice, PhD Rockefeller University
PRS Account Rockefeller University
Verification Date November 2011