Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA

Summary

The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants. The secondary objectives of the study are: * To describe the immune response to yellow fever in both vaccine groups before and after vYF or YF-VAX administration. * To describe the safety profile of vYF vaccine in comparison to the safety profile of the control YF-VAX. * To describe the biosafety profile of vYF in comparison to the biosafety profile of the control YF-VAX.

Timeline

Start

2021-07-01

Primary completion

2022-06-24

Completion

2027-06-29

Publications

• Feroldi E, Mulligan MJ, Talaat KR, Tan CS, Paolino K, Edupuganti S, Collins MH, George SL, Davis M, Essink B, Jeanfreau R, Peterson J, Fried D, Minutello AM, Orlando S, Korejwo J, Rojas A, Dufournet M, Machabert T, Devlin L, Frago C; vYF Vaccine Study Team. Immunogenicity and Safety of vYF, a Yellow Fever Vaccine - A Phase 2 Trial. N Engl J Med. 2026 Apr 9;394(14):1399-1408. doi: 10.1056/NEJMoa2505665.

Drugs

Indications