US Biotechnology firm Centivax has announced the start of a Phase 1A clinical trial evaluating Centi-Flu 01, a pan-influenza universal flu vaccine, in healthy volunteers.
The study is a randomised, double-blind, placebo-controlled, dose escalation study with an open-label active-controlled phase, to evaluate the safety and immunogenicity of Centi‑Flu 01 in healthy adults 18-64 years of age and those 65 and older. The Phase 1A represents a key milestone toward a new kind of flu vaccine designed to provide broader, more reliable protection than standard seasonal vaccines - protecting against currently circulating strains, future strains and pandemic strains.
Unlike conventional seasonal influenza vaccines, which must be reformulated annually to attempt to match predicted circulating strains, Centi-Flu 01 is designed to focus both antibody and cellular immune responses on conserved regions of the influenza virus that cannot mutate and are shared across strains and distance subtypes. This approach aims to generate broad, consistent, and durable immunity against both seasonal and pandemic influenza.
"For decades, flu vaccination has been reactive," said Sawsan Youssef PhD, Founder and Chief Science Officer of Centivax. "A universal influenza vaccine allows us to be proactive - moving from annual guesswork to predictable durable response."
In addition to safety, the study will evaluate efficacy based on established correlates of protection, using the gold-standard hemagglutination inhibition (HAI) assay against a panel of more than twenty flu strains - including currently circulating strains, historical mismatch strains, seasonal guidance strains, and pandemic strains - in a direct head-to-head comparison with existing standard-of-care flu vaccines. Because the HAI assay is the same correlate-of-protection used to license seasonal flu vaccines, positive data will provide a clear benchmark demonstrating the candidate's ability to deliver broad protection with a single vaccine. The first data, in 180 subjects, is expected within the year.
"We are aiming to correct the problem so many of us experience: where, despite taking a flu shot, you still get sick," said Jacob Glanville, PhD, founder and Chief Executive Officer of Centivax. "The Phase 1A is a key value-inflection 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 $7B a year flu market and the unmet medical need of consistent immune protection against flu."
Beyond its flagship universal flu program, Centivax's epitope-focusing platform is advancing a growing pipeline spanning a pan-herpes Alzheimer's preventative, a broad oncology treatment, a malaria vaccine, and a universal antivenom recently published in Cell and featured by major media. Collectively, these programs underscore the universal immunity platform's broad potential to tackle diverse medical threats.