Turnover of Antigen Specific Lymphocytes and Monocytes After Immunization With the 17D Yellow Fev… (NCT01290055) | Clinical Trial Compass
CompletedPhase 4
Turnover of Antigen Specific Lymphocytes and Monocytes After Immunization With the 17D Yellow Fever Vaccine
United States27 participantsStarted 2019-04-15
Plain-language summary
The yellow fever vaccine is a live, attenuated virus that results in a robust immune response, especially in the T cell compartment. The researchers have been studying immune responses to live viral infections using the yellow fever vaccine as a model for a live viral infection. In this study, the researchers are interested in looking at the processing and lifespan of yellow fever specific CD8 T cell by measuring DNA replication and cell proliferation in humans using a naturally occurring stable isotope called deuterium.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Able to understand and give informed consent
✓. Age 18-45 years
✓. Participant agrees not to take any live vaccines 30 days before or after (14 days for inactivated, including coronavirus disease 2019 (COVID-19) vaccination) yellow fever vaccination (not applicable to Group 3 and 4b participants)
✓. Participant agrees to not receive any other vaccination during the 2H2O labeling period
✓. Women of child bearing potential must agree to use effective birth control for the entire duration of the study. A negative urine pregnancy test must be documented prior to vaccination or 2H2O intake. Participants who have a history of surgical sterilization or post-menopausal status \>1 year, are not required to have a pregnancy test.
✓. Positive for the HLA-A2 allele (not applicable to Group 3 or 4 participants)
Exclusion criteria
✕. Prior receipt of a yellow fever vaccine (not applicable for Group 2 participants)
✕. Lived in a country/area which is endemic for yellow fever (not applicable to Group 2 participants)
✕. Travel to country/area which is endemic for yellow fever. Subject to investigator discretion
✕. History of previous West Nile, Dengue, St. Louis encephalitis, Japanese encephalitis vaccination or infection
✕. Any history of allergy to eggs, chicken or gelatin or to any previous vaccine (not applicable to Group 2 (if received YFV-17D outside of study), 3 and 4b participants)
✕. 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.