Codagenix has concluded the dosing of subjects in its Phase I clinical trial of a universal, live-attenuated influenza vaccine, CodaVax-H1N1.
Being carried out in Australia, the double-blind, randomised trial will analyse the safety, tolerability and immunogenicity of the vaccine in healthy subjects aged 18 to 49 years.
It enrolled 45 subjects across three cohorts to receive either intramuscular doses of CovaVax-H1N1 at each dose level or a placebo or a licensed seasonal influenza comparator vaccine.
Assessing the reactogenicity and adverse events following vaccine administration are the trial’s primary endpoints.
The secondary endpoint of the trial is to analyse humoral immune responses induced by an intramuscular dose of CodaVax-H1N1.
Codagenix expects preliminary data from the trial in the fourth quarter of this year.
As against current influenza vaccines that require reformulation every year, CodaVax-H1N1 is a universal influenza vaccine that is said to elicit protection against all influenza strains.
It uses the established benefits of live-attenuated vaccines, which stimulate robust cellular immunity and lasting antibody responses.
CodaVax-H1N1 was developed utilising a codon-deoptimisation platform to exhibit all antigens of the naturally occurring virus and inhibit replication activity within the host by presenting several mutations that code for naturally non-preferred codons.
According to pre-clinical data, CodaVax-H1N1 showed the potential to elicit an antibody response to track antigens from a divergent high-path H5 strain in non-human primates.
Furthermore, this vaccine is made using cell-based manufacturing, which allows for quick scale-up and removes the requirement for expensive egg-based production.
Codagenix co-founder and CEO J Robert Coleman said: “Current influenza vaccines provide inadequate protection against varied seasonal strains or those that threaten to cause a pandemic.
“We are excited to continue this Phase I trial to evaluate the safety and immunogenicity of CodaVax-H1N1 – bringing us one step closer to delivering a universal and broadly accessible solution that does not require annual reformulation.”
Last month, the company, in collaboration with the Serum Institute of India, dosed the first subject in a Phase I trial of a new intranasal vaccine, CoviLiv, as a Covid-19 booster.