Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating respiratory viruses, has announced that all participants have completed their final visit in the Phase 2a clinical booster trial (NCT06582277) evaluating OVX836, Osivax’ broad-spectrum influenza A vaccine candidate.
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Osivax expects to announce final results from the booster trial in H2 2025.
The single-centre, randomised, double-blind, Phase 2a clinical trial is being conducted at the Center for Vaccinology (CEVAC), Ghent University Hospital, in Belgium. The trial is evaluating the immunogenicity and safety of one single dose of OVX836 administered intramuscularly (IM) at either 180μg or 480μg. The study includes 117 healthy adults aged 20-64 who previously participated in Osivax’ Phase 2 trials (NCT04192500 or NCT05060887), conducted 3 and 5 years ago, respectively, and who received either OVX836 (180μg, 300μg or 480μg), Influvac Tetra, or placebo. Participants who had previously received a placebo or Influvac Tetra now serve as controls and have received the highest dose of OVX836 (480 µg) as a primary vaccination.
“Reaching the Last Patient Last Visit in this booster trial is a significant milestone for both our team and the field of influenza vaccine development,” said Prof. Isabel Leroux-Roels, principal investigator at CEVAC and associate professor at Ghent University. “This study offers the opportunity to investigate both primary and booster responses to a novel influenza vaccine over an extended time period. It has been a great experience working alongside the Osivax team, and I look forward to reviewing the data and seeing how OVX836 could contribute to improved influenza prevention strategies in the future.”
“This is an important milestone, not only for Osivax but for the broader effort to advance long-term influenza protection,” said Dr. Nicola Groth, CMO of Osivax. “This trial is unique in that it assesses for the first time the immune response to a booster dose administered several years after initial vaccination. The insights gained will help us understand the persistence and boostability of immune response offered by OVX836, which is essential in our goal to develop a truly broad-spectrum flu vaccine. We are thankful to the participants, investigators, and study teams whose commitment made this trial possible.”