French biotechnology company Osivax has finished enrolling subjects in its Phase I clinical trial of OVX033, a broad-spectrum vaccine candidate targeting sarbecoviruses.
The randomised, placebo-controlled trial is being carried out at the Clinical Investigation Centre in Vaccinology Cochin Pasteur in Paris, part of the Cochin Hospital network.
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It began in February this year and has enrolled 48 adult participants aged between 18 and 49 years.
The trial aims to assess the safety and immunogenicity of OVX033 at 100µg, 250µg and 500µg dosage levels.
Participants will receive a single intramuscular dose of either the OVX033 vaccine or a placebo.
The trial has not yet identified any safety concerns or signals at any of the dosage levels, which allows dosing to be increased to the maximum of 500µg.
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By GlobalDataOVX033 is a coronavirus vaccine candidate that aims to elicit a broad and more universal immune response by targeting the nucleocapsid (N) protein, which is less prone to mutation than surface antigens such as the Spike (S) protein.
The vaccine candidate is intended to trigger T-cell and B-cell immune responses through the use of Osivax’s oligoDOM technology, which allows a recombinant version of the nucleocapsid that self-assembles into nanoparticles to be designed and produced.
In preclinical studies, OVX033 has shown cross-protective efficacy in a hamster challenge model.
Osivax chief medical officer Dr Nicola Groth said: “Sarbecoviruses remain a threat, as evidenced by the Covid-19 pandemic, which continues to have long-term consequences for global health.
“By completing enrolment for our Phase I trial with OVX033, we are taking a significant step forward in addressing the need for a broad-spectrum vaccine to provide protection against these rapidly mutating viruses.”
Other vaccine candidates being developed by Osivax include OVX836, which is currently in Phase II trials for influenza and has yielded “encouraging” efficacy proof-of-concept data.
