Osivax has announced that the first patient has been vaccinated in its phase 2b clinical trial evaluating OVX836, a first-in-class broad-spectrum influenza A vaccine candidate.
The study will assess the efficacy, safety and immunogenicity of OVX836. Unlike conventional influenza vaccines, OVX836 targets an internal antigen, the nucleoprotein, which mutates less frequently than surface antigens.
This approach is designed to elicit a broader immune response by inducing the production of a recombinant version of the nucleoprotein that self-assembles into nanoparticles, stimulating both T cell and B cell activity.
“The initiation of this phase 2b study marks a critical milestone for Osivax,” said Nicola Groth, chief medical officer at Osivax.
The trial will be the first large-scale evaluation of OVX836, with approximately 2,850 participants expected to enrol across 16 European sites.
The candidate has already demonstrated favourable safety, immunogenicity and cross-reactivity in phase 1 and phase 2a studies.
Isabel Leroux-Roels, principal investigator at CEVAC and associate professor at Ghent University, Belgium, highlighted the study’s importance: “Seasonal influenza remains a major public health challenge, and evaluating new vaccine approaches is key to improving prevention strategies.”