Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults

Summary

The primary objectives of the study are: * To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit * To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus * To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.

Timeline

Start

2020-01-15

Primary completion

2021-06-24

Completion

2021-06-24

Publications

• Pagnon A, Carre C, Aguirre M, Chautard E, Gimenez S, Raynal F, Feroldi E, Scott P, Modjarrad K, Vangelisti M, Mantel N. Next generation yellow fever vaccine induces an equivalent immune and transcriptomic profile to the current vaccine: observations from a phase I randomised clinical trial. EBioMedicine. 2024 Oct;108:105332. doi: 10.1016/j.ebiom.2024.105332. Epub 2024 Sep 17.

Drugs

Indications