Lyon, France – March 26, 2024 – Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that all participants have completed their final visit in the Phase 2a clinical trial (NCT05734040) evaluating OVX836, Osivax’ broad-spectrum influenza A vaccine candidate, in combination with Quadrivalent Influenza Vaccines (QIVs). Topline results from this study are expected in the second half of 2024.
The randomized, double-blind, double placebo-controlled, parallel-group, multicentric clinical trial evaluated the safety and immunogenicity of a 480μg dose of the OVX836 vaccine with licensed QIVs and placebo in healthy participants across Australia. The enrolled 478 healthy volunteers from 18 to 60 years old were observed over a period of 180 days following the concomitant administration of the OVX836 vaccine with licensed QIVs, as two separate intramuscular injections into opposite arms, compared to one administration of OVX836, QIVs or placebo.
Laboratory analyses of the vaccine immunogenicity are being performed at VisMederi – Siena, KCAS Bio – Lyon, Osivax Quality Control lab – Angleur, and the CEVAC lab – Ghent.
“The data gathered from this Phase 2a trial is a necessary step in demonstrating OVX836’s ability to provide long-lasting, improved protection in combination with QIVs. We look forward to analyzing the data to confirm the promising results we have observed with OVX836 to date,” commented Dr. Nicola Groth, CMO of Osivax. “We would like to thank the volunteers and dedicated staff of researchers and clinicians whose contributions have ensured the trial’s successful completion.”
“The need for more effective and safe flu vaccines remains high and the conclusion of our trial which evaluates OVX836 in combination with QIVs brings us one step closer to providing improved protection,” said Alexandre Le Vert, CEO and Co-Founder of Osivax. “The data collected from this trial will bolster our development of OVX836 as a broad-spectrum influenza vaccine.” To know more
