NCT00616356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

6 months

First QC Date

January 23, 2008

Last Update Submit

November 7, 2011

Conditions

Keywords

Yellow Fever

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Rockefeller University Personnel

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Charles M Rice, PhD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 15, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations