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Monday, November 29th, 2021

Volunteers issued new Lassa fever vaccine under Phase 1 clinical trial

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A new vaccine candidate — MV-LASV — for Lassa fever has started clinical trials, according to Themis Bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI).

A Phase 1 trial is currently underway, with the vaccine administered to healthy volunteers. The vaccine used comes from Themis and is based on their proprietary measles vector platform, along with exclusively-licensed discoveries made at Institut Pasteur. The MS-LASV vaccine candidate is a recombinant, live attenuated, viral vectored vaccine, and its Phase 1 trial will be randomized and placebo-controlled among 60 adult participants. Two different dose levels will be administered.

“Themis’ versatile technology platform and our ability to rapidly advance candidates into the clinic has been demonstrated previously through the discovery, development, and production of a Phase 3-ready vaccine candidate against Chikungunya as well as our recently announced trial for a novel Zika vaccine,” Themis CEO Erich Tauber said. “Our partnership with CEPI for Lassa fever further validates our capabilities and represents our combined commitment to tackle diseases that remain a public health threat globally.”

Lassa, also known as Lassa hemorrhagic fever, currently has no vaccine. It can cause vomiting, swelling, bleeding, and pain throughout the chest, back and abdomen, and can be spread by rat urine or feces, as well as human-to-human contact through bodily fluids.

CEPI, who funded the vaccine program, wants to help establish an investigational stockpile of the vaccine candidate that would be ready for clinical efficacy trial testing during outbreaks. They will support the candidate’s development through Phase 2.

“Themis was the first company CEPI partnered with to develop a vaccine against Lassa fever and MERS, two of our priority pathogens,” Melanie Saville, director of Vaccine Development at CEPI, said. “Lassa fever remains a serious public health threat across West Africa, with Nigeria alone experiencing its largest ever outbreak of the disease this year. This first in-human trial for Themis’ MV-LASV Lassa candidate is an important first step in its evaluation in the clinic and toward developing an effective vaccine which will be available to at-risk populations during outbreaks of this deadly emerging infectious disease.”

The study is being led and sponsored by Themis, but conducted by the Centre for the Evaluation of Vaccination in Antwerp, Belgium.