Osivax has kickstarted its Phase I clinical trial (NCT06128382) by vaccinating the first participant with its OVX033 sarbecovirus (coronavirus) vaccine candidate.
The 48-participant trial will evaluate the safety and immunogenicity of OVX033 at three dose levels, 100 µg, 250 µg, and 500 µg. Healthy participants aged 18-49 will receive a single dose of the vaccine or a placebo intramuscularly.
Sarbecovirus is a virus subgenus that includes the severe acute respiratory syndrome coronavirus (SARS-COV-2), which was responsible for the Covid-19 pandemic. Broad spectrum vaccine candidates like OVX033 are meant to provide protection against multiple strains or variants of a particular virus.
OVX033 advanced into human clinical trials after demonstrating a good safety and tolerability profile in a hamster challenge model, based on results published in Frontiers in Immunology. The candidate targets the nucleocapsid (N) antigen. Unlike surface antigens such as spike (S), N has lower mutation rates, ensuring a wider and more inclusive immune response.
This approach induces broad-spectrum protection against existing and future variants of SARS-COV-2, as well as against potential future pandemic coronavirus strains.
Osivax utilised its novel proprietary nanoparticles technology oligoDOM to make OVX033, previously using the technology to develop Osivax’s Phase II broad-spectrum influenza A vaccine candidate OVX836.
In the announcement accompanying the dosing, CEO of Osivax Alexandre Le Vert said: “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.”
Both the US Food and Drug Administration (FDA) and European agencies have emphasised the need for new vaccines that can target emerging Omicron strains of SARS-CoV-2. Earlier this year, ExeVir’s Covid-19 vaccine demonstrated neutralisation against various Omicron variants, with the company announcing its plan to start clinical trials.
