Osivax, a biopharmaceutical company focused on developing broad-spectrum vaccines against highly mutating infectious viruses, has announced the first participant has been vaccinated in a Phase 2a clinical trial (NCT06582277) evaluating OVX836, its broad-spectrum influenza vaccine candidate, as a booster in individuals previously administered with OVX836. This study aims to further investigate the safety and immunogenicity of a booster dose of OVX836, building upon encouraging data from earlier trials.
The Phase 2a trial is being conducted at the Center for Vaccinology (CEVAC) at Ghent University Hospital. Participants enrolled in the study previously received OVX836 in earlier Osivax studies three to five years ago. Topline results from the trial are anticipated by the end of 2025.
Study Design and Objectives
The single-center trial employs a randomized, double-blind, Phase 2a design to assess the immunogenicity and safety of a single intramuscular dose of OVX836. Participants receive either 180µg or 480µg of OVX836. The study includes healthy adults aged 20-64 who had previously received OVX836 (180µg to 480µg), Influvac Tetra, or placebo in the OVX836-002 (NCT04192500) and OVX836-003 (NCT05060887) studies.
OVX836: A Novel Approach to Influenza Vaccination
OVX836 is a first-in-class influenza A vaccine candidate targeting the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is less prone to mutation, potentially offering a broader and more universal immune response. Osivax's oligoDOM technology facilitates the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle, triggering robust T- and B-cell immune responses. To date, OVX836 has been evaluated in five clinical trials involving 1,200 participants, demonstrating promising safety, immunogenicity, and efficacy profiles.
Expert Commentary
"We are pleased to support the ongoing evaluation of OVX836 through this phase 2a influenza booster study," commented Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC and Associate Professor at Ghent University. "We anticipate important insights that could significantly impact long-term influenza prevention."
Dr. Nicola Groth, CMO of Osivax, added, "This milestone is a significant step forward in our mission to develop a truly broad-spectrum, lasting flu vaccine capable of addressing the ever-evolving threat of influenza. By studying the effects of a booster dose, we aim to deepen our understanding of OVX836’s potential to provide robust and sustained immune protection."
