Vaxxas today announced clinical trial data demonstrating the potential of its high-density microarray patch (HD-MAP) for vaccine delivery.
The company published the data highlighting effective vaccine payload delivery in Human Vaccines & Immunotherapeutics. This counts for both trained professionals and individual self-administration.
Vaxxas reported an equivalency of observed human skin response and vaccine delivery potential between professional and self-administration.
The study involved 20 healthy participants between 18 and 45 years old. Thirteen participants identified as female. Vaxxas coated the HD-MAPS with a biologically inert and fluorescent coating (without a vaccine). A trained user applied the patches to the upper arm, volar forearm and posterior shoulder of each participant.
Each participant then followed written and pictorial instructions to complete self-administration to all three locations. Each participant completed a total of six applications.
Vaxxas reported no observed difference between skin response and patch fluorescent coating deposition at application site between both types of application.
“With this promising initial validation of our needle-free vaccine technology platform’s self- or lower-skilled administration potential, we believe we are on a pathway to offering a truly differentiated alternative to delivering vaccination with a global reach, particularly into lower- and middle-income countries or in emergency use pandemic situations,” said Vaxxas CTO and co-author of the publication Dr. Angus Forster.
More about the Vaxxas needle-free vaccine study
Participants tolerated HD-MAP well with no serious adverse events reported. Vaxxas said 70% expressed a preference for HD-MAP application to the upper arm compared to the other tested sites.
Results of this study add to previously published data demonstrating the stability of an influenza vaccine delivered by HD-MAP. This showed the technology remains stable when stored at 40°C (104°F) for up to 12 months. That could lead to easier distribution without the cost and complexity of continuous refrigeration.
HD-MAP could potentially ship direct to homes or pharmacies for multiple kinds of administration outside the traditional clinical setting. That may prevent the need for populations to congregate in large numbers to have a vaccine administered. Vaxxas believes this could offer massive benefits in situations like a pandemic response.
“The coronavirus SARS-CoV-2 (COVID-19) pandemic has highlighted the need for continued innovation in how vaccines are delivered and administered,” Dr. Forster said. “We see tremendous potential for our HD-MAP with its clinically demonstrated benefits, including reduced vaccine dose and no cold-chain storage requirement, combined with the prospect of self-administration.”