The randomised, placebo-controlled study aims to assess the immunogenicity and safety of sarbecovirus vaccine candidate. Credit: Tero Vesalainen / Shutterstock.com.

Osivax has commenced the Phase I clinical trial of its broad-spectrum sarbecovirus vaccine candidate, OVX033, with the first participant receiving the vaccination.

The trial will be carried out at the Clinical Investigation Center in Vaccinology Cochin Pasteur (CIC) in Cochin Hospital in Paris, under the supervision of Paris Cité University professor Odile Launay.

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It is a first-in-human, single-centre, double-blind, randomised, placebo-controlled study aimed at assessing the immunogenicity and safety of OVX033 at three varying dose levels: 100µg, 250µg, and 500µg.

It will enrol 48 healthy individuals aged 18 to 49 years in France. They will be given a single intramuscular dose of either the OVX033 vaccine or a placebo.

OVX033 targets the nucleocapsid (N) protein, an internal antigen of the coronavirus that is highly conserved and less prone to mutations versus surface antigens like the Spike (S) protein.

The vaccine candidate’s goal is to induce a broad immune response, potentially offering protection against all current and future SARS-CoV-2 variants, as well as future pandemic coronavirus strains.

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It leverages Osivax’s oligoDOM technology, which facilitates the production of a recombinant version of the nucleocapsid that self-assembles into nanoparticles, intended to elicit strong T- and B-cell immune responses.

OVX033 has shown preclinical proof of concept for cross-protective efficacy in a hamster challenge model and has demonstrated cross-protection against three SARS-CoV-2 variants of concern in recently published preclinical data.

Additionally, the vaccine has exhibited a safety and tolerance profile in a rabbit toxicology study following intramuscular administration.

Osivax CEO and co-founder Alexandre Le Vert said: “Transitioning our second broad-spectrum vaccine candidate into the clinic further validates our self-assembling nanoparticle platform, OligoDOMTM, and our position as a pioneer in the advancement of a new class of vaccines. 

“With the Phase I 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.”