Novavax Initiates Phase 1/2 Clinical Trial Combination Vaccine for COVID-19 and Seasonal Influenza
Novavax has enrolled the first participants in a Phase 1/2 clinical trial of a combination vaccine using its seasonal influenza and COVID-19 vaccines, together with its patent saponin-based Matrix-M TM adjuvant. Both vaccines have individually demonstrated strong results. The study will evaluate the immunogenicity and safety of multiple formulations of the combination vaccine administered to randomized groups, with the aim of achieving an enhanced level of protection against both COVID-19 and influenza.
The first participants have been enrolled in a Phase 1/2 study evaluating safety, tolerability and immunogenicity of a vaccine combining Novavax’ recombinant protein-based NVX- CoV2373 and NanoFlu™ vaccine candidates and patented saponin-based Matrix-M™ adjuvant in a single COVID-NanoFlu Combination Vaccine.
The randomized trial will enrol adults between the ages of 50 and 70, who have either been previously infected with SARS-CoV-2 or vaccinated, and who will receive 2 doses with a gap of 2 months. The COVID-NanoFlu Combination Vaccine showed positive immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein in preclinical studies.
NVX-CoV2373 demonstrated 100% protection against COVID-19 and 90.4% overall efficacy in a large-scale Phase 3 clinical trial in the U.S. and Mexico. In a Phase 3 trial, NanoFlu satisfied the primary endpoints, with a consistent immune response in comparison to a licensed comparator as well as enhanced antibody responses. When evaluated in a co-administration study together with an approved influenza vaccine, results showed preservation of vaccine efficacy in those administered both vaccines as compared to those vaccinated with just NVX-CoV2373.
“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,” said Gregory M. Glenn, M.D., President of Research and Development at Novavax. “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.”
NVX-CoV2373 is a protein-based vaccine candidate derived from Novavax’ recombinant nanoparticle technology and is formulated with its patented saponin-based Matrix-M TM adjuvant to generate a stronger immune response and high levels of neutralizing antibodies. The candidate demonstrated an ability to provide protection from infection and disease in preclinical trials and showed tolerability and robust antibody responses in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two Phase 3 trials – in the U.K. and in the U.S. and Mexico – and in two Phase 2 studies – in South Africa and in Australia.
About Matrix-M TM Adjuvant
The saponin-based Matrix-M TM adjuvant has shown high potency and tolerability by enhancing antigen presentation and boosting immune response.
About NanoFlu TM
NanoFlu™ is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine, which contains Novavax’ patented saponin-based Matrix-M TM adjuvant.
Novavax is a biotechnology company focused on the discovery, development and commercialization of innovative vaccines targeting serious infectious diseases. Its proprietary recombinant technology platform produces highly immunogenic nanoparticles designed to address urgent global health needs. For more information, visit www.novavax.com.