Novavax launches Phase 1/2 trial to chart immunogenicity, safety of combo-COVID-19 and flu vaccine

Novavax, Inc. began enrollment last week of the first participants for a Phase 1/2 clinical trial to assess the safety and immunogenicity of a combination vaccine formed from the company’s seasonal influenza and COVID-19 vaccines.

Each vaccine has already been tested in solo clinical trials up through Phase 3, but now the company wants to see if in the form of the COVID-NanoFlu Combination Vaccine they might be able to protect against both conditions at the same time. Tolerability, immune response and the safety of the combo vaccine will be the focuses of the trial, which will consist of 640 otherwise healthy Australians between 50-70 years old. All will have either been previously infected by the SARS-CoV-2 virus that causes COVID-19 or fully vaccinated against it.

“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,” Dr. Gregory Glenn, president of R&D at Novavax, said. “The combination of these two vaccines, which have individually delivered outstanding results with favorable 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 new vaccine has already undergone preclinical studies, which saw it used on ferrets and hamsters. Therein, it produced elevated antibody levels against SARS-CoV-2 and influenza A and B strains alike. Antibody titers in ferrets remained elevated two weeks after a single dose, increasing further after a second dose. Little or no virus could be detected in immunized animals’ upper and lower respiratory tracts four days after infection.

Separately, in a Phase 3 clinical trial of nearly 30,000 adults in North America, the COVID-19 side of the concoction — NVX-CoV2373 — produced 90.4 percent efficacy against infection overall. NanoFlu, for influenza, produced non-inferior immunogenicity against four influenza strains in a Phase 3 trial of adults at least 65 years old, as well as heightened antibody and T cell responses.

During the upcoming trial, the COVID-NanoFlu Combination Vaccine will be randomly assigned to participant cohorts through multiple formulations. It will be distributed in two doses, one to start and another issued on Day 56. Results are expected during the first half of 2022.