NanoFlu vaccine was well tolerated over the three-week trial period, Novavax said Thursday, adding it now expects to begin a Phase 2 trial of its recombinant influenza vaccine, which includes its proprietary Matrix-M adjuvant, in the third quarter of 2018.
Top-line results from its Phase 1/2 clinical trial were positive in older adults of its NanoFlu recombinant influenza vaccine, compared to the leading licensed egg-based, high-dose influenza vaccine for older adults (IIV3-HD), Navovax said on Thursday in a press release.
H3N2 has been a consistent public health challenge and is associated with roughly 75% of this season’s flu-related hospitalizations. Against three tested H3N2 strains, the ratio of day 21 HAI geometric mean titers (GMTs) show significant responses of NanoFlu vaccine over IIV3-HD.
In the Phase 1/2 clinical trial, Novavax has conducted a randomized, observer-blind, comparator-controlled trial of NanoFlu vaccine against IIV3-HD in healthy adults aged 60 years or older. Vaccine immunogenicity was measured by HAI and neutralization antibody responses against a panel of vaccine-homologous, and historically and forward-drifted, influenza virus strains.
NanoFlu vaccine is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu vaccine uses HA amino acid protein sequences that are substantially the same as wild-type circulating virus HA sequences. NanoFlu vaccine contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.
(There was a typo in the title of this article, saying the name of the company was “Novovax”