DMID 23-0015; Lassa Fever CVD 1000

Summary

This study proposes the evaluation of a novel, first-in-human Lassa fever vaccine based on the complete Lassa glycoprotein complex (GPC) antigen. The antigen will be presented on a genetically modified and attenuated rabies vector expressing both the rabies glycoprotein (GP) antigen and the Lassa GPC. The inactivated chimeric virus is delivered with a toll-like receptor (TLR-4)-activating oil-in-water emulsion adjuvant. Studies using this vaccine administered as a prime-boost series in mice and non-human primates, and then challenged with Lassa virus demonstrated significant protection against Lassa fever. Given that the vaccine backbone is an attenuated and inactivated rabies virus expressing rabies GP, this vaccine will also be evaluated for immunogenicity against rabies virus.

Timeline

Start

2025-01-13

Primary completion

2026-05

Completion

2026-05

Publications

• Ortiz JR, Kurup D, Kaufman AC, Ben Hamed S, LaRocco AM, Lyke KE, Litts SM, Datta S, Liang Y, McGilvray MF, Losignor JA, Oshinsky JJ, Palmer KV, Johnson-Mayo IP, Scher G, Balakumar U, Chandwani A, Rapaka RR, Deming ME, Chua JV, Wirblich C, Chen WH, Neuzil KM, Pasetti MF, Schnell MJ. Adjuvanted inactivated rabies virus-vectored Lassa virus vaccine in healthy adults: a phase 1 trial. Nat Med. 2026 Jun 9. doi: 10.1038/s41591-026-04429-z. Online ahead of print.

Drugs

Indications