3D illustration showing surface glycoprotein spikes of influenza. No universal vaccine for influenza currently exists. Instead, regular vaccines are given that target seasonal strains. Image credit: Shutterstock/Kateryna Kon.

France-based biotech company Osivax has thrown its hat into the influenza ring by dosing the first subject with its vaccine candidate OVX836.

The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs).

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The developer has tested OVX836 in four completed clinical trials.

In a company statement announcing the latest trial kick-off, Osivax said a recently completed separate Phase IIa trial demonstrated that the candidate in combination with QIVs had a good safety profile with no impairment of immune response by the QIVs.

The aim of the latest ongoing trial is to evaluate the vaccine in a larger and more diverse population. The company aims to enrol more than 500 participants aged 18-60 across multiple clinical sites in Australia.

The OVX836 vaccine targets nucleoprotein – a conserved internal antigen. Internal antigens, unlike surface antigens, have a lower probability of mutation and subsequently make for better targets when designing a universal vaccine that addresses multiple strains.

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Osivax will divide participants into six groups in the multi-centred, randomised, double-blind, double placebo-controlled trial. Two groups will be concomitantly administered with OVX836 and either GlaxoSmithKline’s Fluarix Tetra (inactivated split influenza virus) or Seqirus’ Afluria Quad (influenza virus haemagglutinin) in opposite arms. The remaining four groups will receive different combinations of the candidate, placebo, and QIV.

Influenza vaccine landscape

The quest for a vaccine that protects against a wide range of influenza strains has rumbled without success outside of trials. Currently, strains that are predicted to dominate are certain points of the year are included in seasonal influenza vaccines.

Interest in the hunt for a universal influenza vaccine is widespread because a shot of a single vaccine may be able to protect against multiple strains, as well as unanticipated mutations.

Osivax’s OVX836 is joined by fellow T-cell vaccine Flu-v from Imutex as candidates already in Phase II trials. Also in the race is an mRNA-based candidate designed by the Vaccine Research Centre (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), which just entered a Phase I trial.