Flu Vaccine Patch Candidate Produced Positive Results Avoiding Needlephobia

Vaxess Technologies, Inc. recently announced positive interim results from a first-in-man phase 1 clinical trial of VX-103, a monovalent seasonal influenza vaccine patch.

Once placed on the skin, each MIMIX™ patch delivers a microarray of slow-release, bioactive tips into the immunologically active dermal barrier.

These bioactive tips gradually dissolve into the body after the patch is removed, releasing their payload of vaccines and therapeutics over time.

The patches were worn for only five minutes.

The flu vaccine patches were well tolerated, with no severe adverse events.

The overall rate of reported systemic events was favorable compared to traditional vaccines delivered by needle and syringe.

Day 57 results show MIMIX-Flu significantly exceeded the 2007 U.S. Food and Drug Administration criteria for accelerated licensure of influenza vaccines, with the 15ug and 7.5ug patches leading to seroconversion rates of 85% and 77%, respectively, along with seroprotection rates of 92% and 92%. 

"Only half of US adults get a seasonal influenza vaccine," said Michael Schrader, CEO, and co-founder of Vaxess, in a press release on December 14, 2022.

"This exciting early data combining GC Biopharma Corp.'s safe and effective influenza vaccine with the MIMIX patch points to a future product that will overcome many barriers to keeping this rate so low, including needlephobia, inconvenience, and side effects such as injection site pain."

The trial, conducted in 45 healthy patients, evaluated the H1N1 influenza antigen from Vaxess's partner, GC Biopharma Corp., delivered via the MIMIX Patch. Vaxess enrolled 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.

In previous non-human 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. The study also showed that sustained-release immunization promotes strong and long-lasting anti-influenza antibody responses and enhanced protection against fatalities.

In parallel with its influenza vaccine trial, Vaxess is applying its MIMIX Array Patch System to COVID-19 vaccines.

The effort, funded initially through a U.S. BARDA contract, aims to develop a seasonal booster that overcomes challenges with existing COVID vaccines, including the need for frozen storage and clinical administration.

Additional flu shot news for 2022 is posted at PrecisionVaccinations.com/Flu.