Osivax Announce First-in-Human Phase 1 Vaccination Trial

Osivax have announced that the first participant has been vaccinated in its new Phase 1 trial (NCT06128382) evaluating OVX033, a broad-spectrum sarbecovirus vaccine candidate. 

Recently, preclinical data published in Frontiers in Immunology demonstrated OVX033’s proof of cross-protection against three SARS-CoV-2 variants of concern. In a rabbit toxicology study, the vaccine candidate also showed an strong safety and tolerance profile after intramuscular administration. The first-in-human study will be conducted at the Clinical Investigation Center in Vaccinology Cochin Pasteur (CIC) in Cochin Hospital in Paris (AP-HP, Inserm) under the supervision of Odile Launay, MD, PhD, Professor at Paris Cité University.

“OVX033 has been shown in preclinical models to effectively provide broad protection across multiple strains of coronavirus,” commented Prof. Odile Launay, the Principal Investigator. “We are proud to participate in this first-in-human study to evaluate the vaccine candidate’s role in preventing the pandemic-level spread of current and future SARS-CoV-2 variants.”

“Transitioning our second broad-spectrum vaccine candidate into the clinic further validates our self-assembling nanoparticle platform, OligoDOM, and our position as a pioneer in the advancement of a new class of vaccines,” said Alexandre Le Vert, CEO & Co-Founder of Osivax. “With the Phase 1 initiation for OVX033 underway, we hope to advance a broad-spectrum coronavirus vaccine that can be positioned against all SARS-CoV-2 variants and against future coronavirus pandemic threats.”

The single-centre trial is a randomised, double-blind, placebo-controlled Phase 1 clinical study evaluating the safety and immunogenicity of OVX033 at three dose levels (100 µg, 250 µg, and 500 µg). One single dose of OVX033 vaccine or of placebo will be administered intramuscularly in 48 healthy subjects aged 18-49 years. 

OVX033 is based on Osivax’ cutting-edge technology, OligoDOM, which has already established promising proof-of-concept data with OVX836, a broad-spectrum influenza A vaccine candidate currently being evaluated in several Phase 2 clinical studies.

Results on immunogenicity, safety and preliminary efficacy were published inThe Lancet Infectious Disease in 2023.