Novavax has initiated patient enrolment in a Phase I/II study of a combination vaccine using its seasonal influenza and Covid-19 vaccines.
The trial will be conducted in Australia at up to 12 study sites and aims to evaluate the safety and immunogenicity of the combination vaccine in 640 healthy adults.
It combines Novavax’ recombinant protein-based NVX-CoV2373 and NanoFlu vaccine candidates and saponin-based Matrix-M adjuvant in a single formulation known as the COVID-NanoFlu Combination Vaccine.
NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase III clinical trials.
Novavax Research and Development president Gregory Glenn said: “This study is the first-of-its-kind to evaluate the vaccine’s potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously.
“The combination of these two vaccines, which have individually delivered outstanding results with favourable safety and tolerability profiles, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against Covid-19 and influenza with a single regimen.”
The trial will evaluate the safety, tolerability and immune response to NanoFlu formulated along with NVX-CoV2373 and Matrix-M adjuvant in adults aged 50 to 70 years.
It will enrol adults who have been either infected with the SARS-CoV-2 virus earlier or given an authorised vaccine at least eight weeks before enrolment.
For evaluating multiple formulations, all of them will be randomly assigned to cohorts and dosed on Day 0 and again at Day 56.
The trial results are expected during the first half of next year.
The COVID-NanoFlu Combination Vaccine demonstrated robust, functional immune responses in preclinical studies.
Last December, Novavax initiated a pivotal Phase III study of its Covid-19 vaccine candidate, NVX-CoV2373, in the US and Mexico.