Biopharmaceutical company Osivax has vaccinated the first subject in its randomised Phase IIb trial of OVX836 for influenza A.
The multi-centre, double-blind study is set to recruit around 2,850 individuals aged 18 to 59 across 16 sites in various European nations.
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This trial aims to test the immunogenicity, efficacy, and safety of OVX836 in shielding individuals from influenza infections in the upcoming flu season.
OVX836 aims to offer broad-spectrum protection against influenza and is said to have shown positive safety, cross-reactivity, and immunogenicity in earlier Phase I and Phase IIa trials, along with encouraging efficacy signals.
Osivax chief medical officer Dr Nicola Groth said: “The initiation of this Phase IIb study marks a critical milestone for Osivax as we continue to advance our broad-spectrum influenza A vaccine candidate, OVX836.
“We are grateful for the close collaboration with all our investigators, clinical partners, and internal teams who have made it possible to launch this large-scale efficacy trial well ahead of the flu season.”
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By GlobalDataAccording to the company, the vaccine candidate targets the nucleoprotein (NP), an internal antigen of the influenza virus that is less susceptible to mutations, potentially offering long-lasting immune protection.
It leverages the company’s oligoDOM technology, which facilitates the design and production of a recombinant NP that is said to self-assemble into nanoparticles, aiming to elicit both T-cell and B-cell immune responses.
The vaccine has so far been evaluated in seven studies involving more than 1,400 subjects.
The company is developing a suite of influenza vaccines that generate T-cell responses and sustained B-cell responses, utilising oligoDOM technology.
Last year, Osivax finished enrolling subjects in its Phase I trial of OVX033, a broad-spectrum vaccine candidate that targets sarbecoviruses.
