A Phase I/II Study Of The Immunogenicity Of The Yellow Fever Vaccine 17D (YFVax®) In Adults With Prior 17D Vaccination
Oregon Health and Science University
Summary
The goal of this clinical trial is to assess the immune response to the yellow fever vaccine 17D in adults with prior 17D vaccination. The main questions this study aims to answer are: * how does prior vaccination affect antibody responses to re-vaccination? * how does prior vaccination affect the immune cell response to re-vaccination? Participants will: * have been previously vaccinated with 17D. * be re-vaccinated with 17D. * provide medical and travel histories. * provide a blood sample prior to vaccination * provide a blood sample approximately every other day for 14 days after vaccination. * provide a blood sample approximately 28 days after vaccination. * complete a daily diary of symptoms following vaccination for 14 days. * report any additional symptoms after 14 days.
Description
In this study the investigators use 17D revaccination as a live-virus challenge to test the hypothesis that neutralizing antibody titers correlate with YFV protection. The investigators will prospectively characterize pre-boost antibodies titers, vaccine viremia, acute immune responses and post-boost titers in vaccinees receiving boost 17D vaccinations. The investigators expect to identify neutralizing antibody titers above which sterilizing immunity is conferred and titers below which it is not. These Aims will set a foundation for future studies to further dissect determinants of 17D and oth…
Eligibility
- Age range
- 20–49 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Aged ≥20 to \<50 years. 2. Male or female. 3. In good health at the time of screening as determined by medical history, physical examination, and clinical judgement of the investigator. 4. Documented history of Yellow fever vaccination 8 or more years prior. Documentation must be on a primary (not copied) vaccination card or a fully completed electronic medical record entry including date of administration and lot number administered. 5. Subjects who can comply with all trial procedures and are available for the duration of follow-up. Exclusion Criteria: 1. A clinical…
Interventions
- Biological17D
Vaccine administration in subjects previously vaccinated with 17D.
Location
- Oregon Health & Science UniversityPortland, Oregon