Flu Shot Patch Launches Early-Stage Study
Massachusetts-based Vaxess Technologies, Inc. recently announced that it had launched a phase 1 clinical trial for the H1 influenza vaccine delivered via Vaxess's MIMIX™ patch. The Company intends to report the initial finding in 4Q2022.
Vaxess confirmed on August 3, 2022, it had enrolled 45 healthy adult volunteers ages 18-39 to evaluate the safety, reactogenicity, tolerability, and immunogenicity profiles for two influenza vaccine dose levels, fractional H1 vaccine dose level 7.5 μg and standard H1 vaccine dose level 15 μg vs. placebo.
Vaxess will also evaluate the durability of the immune response for each vaccine dose level and assess, in at least a subset of samples, the breadth of influenza A H1 antigen responses.
For the phase 1 trial, the H1 influenza vaccine is delivered by VX-103 (a MIMIX Array Patch System).
In the previous testing of Vaxess's influenza MIMIX Array Patch system on mice, the Company found enhanced humoral and cellular immune responses to the influenza vaccine when compared to receiving the vaccine via intramuscular injection.
"...getting a vaccine usually means receiving an injection via syringe and needle ... which is uncomfortable and time-consuming ... and requires extraordinary supply chain resources to distribute temperature-controlled vaccines to pharmacies, hospitals, and doctors' offices," said Lynda Tussey, chief development officer at Vaxess, in a press release.
"Vaxess's MIMIX patch will make distributing and administering vaccines easier."
"Soon, we'll live in a world where you can have a vaccine patch mailed right to your door, and put it on in the comfort of your home, whether for a seasonal vaccination or to address a future COVID-like pandemic."
Vaxess's phase 1 trial builds on the Company's research published in September 2021, "Enhancing influenza vaccine immunogenicity and efficacy through infection mimicry using silk microneedles."
The study showed that sustained release immunization promotes strong and long-lasting anti-influenza antibody responses and enhanced protection against fatalities.
Additional U.S. FDA-authorized influenza vaccine information for the 2022-2023 flu season is posted at PrecisionVaccinations.com/Flu.
Note: Vaxess press release was manually curated for mobile readers.