Positive Clinical Study Results for Recombinant Flu Vaccine Announced
NanoFlu Influenza Vaccine Demonstrates Improved Immune Responses Compared to Egg-Based, High-Dose Flu Vaccine
Seniors experience various health complications during the flu season.
In recent years, it’s estimated that up to 85 percent of seasonal flu-related hospitalizations and deaths have occurred in people 65 years+.
A phase 1/2 clinical trial in 330 older adults for a new flu vaccine reported very positive results when compared against the H3N2 strain.
The H3N2 strain has been associated with about 75 percent of the 2018 season’s flu-related hospitalizations, reported the Centers for Disease Control and Prevention (CDC).
The NanoFlu recombinant influenza vaccine was compared with a leading licensed egg-based, high-dose influenza vaccine for older adults (IIV3-HD), and the key findings of this clinical study were:
- Significantly higher hemagglutination inhibition (HAI) antibody responses against homologous H1N1 and H3N2 strains and comparable HAI responses against the homologous B/Brisbane strain,
- Significantly higher HAI immune responses against historic and forward-drifted H3N2 strains, and,
- Strong neutralizing antibody responses that correlate with HAI results against H3N2 strains.
NanoFlu vaccine uses HA amino acid protein sequences that are substantially the same as wild-type circulating virus HA sequences.
Against three tested H3N2 strains, the ratio of day 21 HAI geometric mean titers (GMTs) show significant responses of NanoFlu vaccine over IIV3-HD:
- 47% higher NanoFlu response against homologous strain (A/Hong Kong),
- 64% higher NanoFlu response against forward-drifted strain (A/Singapore),
- 54% higher NanoFlu response against historic strain (A/Switzerland).
This clinical trial was a randomized, observer-blind, comparator-controlled trial of NanoFlu vaccine (in two trivalent formulations: 45µg or 180µg total HA) 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.
Overall, NanoFlu vaccine was well tolerated over the three-week trial period, said Novavax, Inc., a clinical-stage biotechnology company.
Novavax now expects to begin a Phase 2 trial of its NanoFlu vaccine in the third quarter of 2018.
No pricing information for NanoFlu was disclosed by Novavax.
In 2013, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) unanimously recommended Flublok for seniors, including those with egg allergies.
Most pharmacies offer several FDA approved flu vaccines.
The CDC Vaccine Price List provides the private sector prices for general information.
Flu vaccine discounts can be found here.
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