Vaxess Technologies today announced positive interim results from a first-in-human trial of its influenza vaccine patch.
Cambridge, Massachusetts-based Vaxess evaluated VX-103, a monovalent seasonal influenza vaccine patch. The trial included 45 healthy patients and evaluated the H1N1 influenza antigen from Vaxess’ partner, GC Biopharma.
Delivery of the vaccine took place through the Vaxess Mimix patch.
Vaxess enrolled healthy adult volunteers between ages 18 and 39 years old. It evaluated the safety, reactogenicity, tolerability and immunogenicity profiles for two influenza vaccine dose levels. Those levels included H1 vaccine dose level 7.5 μg and standard H1 vaccine dose level 15 μg vs placebo. Subjects only wore their Mimix patches for five minutes.
According to a news release, patients reported the patches as well-tolerated with no serious or severe adverse events. Results at day 57 showed that Mimix-Flu significantly exceeded the 2007 FDA criteria for accelerated licensure of influenza vaccines. The 15ug and 7.5ug patches led to seroconversion rates of 85% and 77%, respectively. They each produced seroprotection rates of 92%.
“Only half of U.S. adults get a seasonal influenza vaccine,” said Michael Schrader, CEO and co-founder of Vaxess. “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 of the barriers keeping this rate so low, including needlephobia, inconvenience, and side effects such as injection site pain. We look forward to working with GC Biopharma Corp. to rapidly move this product through the clinic to positively impact patients’ lives.”
Vaxess plans to follow subjects out to 180 days to evaluate long-term safety for the patch. It also intends to evaluate the durability of immune response for each vaccine dose level. In a subset of samples, it may study the breadth of influenza A H1 antigen responses.