Novavax' NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced in a Sf9 insect cell-baculovirus system.
NanoFlu uses HA protein amino acid sequences that are the same as the recommended wild-type virus HA sequences.
NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which is potent, well-tolerated and stimulates both high quality and durable antibody responses as well as multifunctional CD4 and CD8 T-cell responses.
NanoFlu is an influenza vaccine candidate in a phase 2 clinical study.
The trial compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax’ Matrix-M™ adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older.
January 03, 2019, Novavax announced top-line results of its Phase 2 clinical trial of NanoFlu.
Novavax will again meet with the FDA in the first half of 2019 to discuss the Phase 2 clinical trial data, the proposed Phase 3 trial design, and the use of accelerated approval for licensure.
Key findings of this Nanoflu clinical trial:
- All formulations of NanoFlu were well-tolerated and elicited vigorous immune responses to the four strains included in the vaccine.
- Matrix-M adjuvant resulted in significant enhancement of immune responses when compared to the unadjuvanted formulation.
- NanoFlu is a differentiated flu vaccine, as evidenced by significantly superior hemagglutination inhibition (HAI) antibody responses against wild-type A(H3N2) viruses, including drifted strains, when compared to Fluzone High-Dose, the leading flu vaccine in older adults.
- 45% increase against the vaccine-homologous virus, A/Singapore (p<0.001)
- 22% increase against a historic drifted virus, A/Switzerland (p=0.014)
- 42% increase against a forward drifted virus, A/Wisconsin (p<0.001)
- NanoFlu formulation identified for the Phase 3 clinical trial and commercialization.
Clinical Trial NCT03658629: Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults