Centivax has commenced participant dosing in its Phase Ia clinical trial, assessing Centi-Flu 01, a pan-influenza universal vaccine for flu.
The randomised, double-blind, placebo-controlled, dose escalation trial includes an open-label active-controlled phase and involves healthy adults aged 18-64, as well as those 65 and above.
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The vaccine aims for broad protection against seasonal, future, and pandemic influenza strains.
Unlike standard seasonal influenza vaccines requiring annual reformulation to match predicted strains, Centi-Flu 01 targets conserved regions of the influenza virus that cannot mutate and are present across multiple subtypes.
This approach is intended to elicit both antibody and cellular immune responses, potentially providing durable and consistent immunity to a wide range of influenza viruses.
The study will assess the safety and immunogenicity, as well as efficacy, using established correlates of protection.
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By GlobalDataThe gold-standard haemagglutination inhibition (HAI) assay will be utilised to compare immune responses against a panel of more than 20 flu strains. These include historical mismatch, current circulating, pandemic strains, and seasonal guidance, directly against existing standard-of-care flu vaccines.
Initial data from 180 participants are anticipated within the year.
Centivax founder and CEO Jacob Glanville said: “We are aiming to correct the problem so many of us experience: where, despite taking a flu shot, you still get sick.
“The Phase Ia is a key value-inflexion point for the company because we will see very quickly whether the vaccine—and the universal immunity platform—is working and if it outperforms standard of care.
“This accelerates us towards the very large $7bn a year flu market and the unmet medical need of consistent immune protection against flu.”
Beyond this programme, Centivax is advancing candidates for a pan-herpes Alzheimer’s preventative, oncology treatments, malaria vaccines, and a universal antivenom.
The research is supported by more than $26m in non-dilutive financing from philanthropic groups and US government agencies dedicated to pandemic preparedness.
