Georgia Tech tests microneedle flu vaccine patch

ATLANTA — The Georgia Institute of Technology last week tested a new pain-free flu vaccine patch that could one day be self-administered.



“Despite the recommendation of universal flu vaccination, influenza continues to be a major cause of illness leading to significant morbidity and mortality,” said first author Nadine Rouphael, associate professor of medicine (infectious diseases) at Emory University School of Medicine and principal investigator of the clinical trial. “Having the option of a flu vaccine that can be easily and painlessly self-administered could increase coverage and protection by this important vaccine.”



Using microneedle patch technology under development at Micron Biomedical, a Phase 1 clinical trial published last week found that vaccination by microneedle patch was as safe and at least as immunogenic as vaccination with standard needle and syringe. The trial was carried out by Georgia Tech and the Emory University Hope Clinic. The results were published in The Lancet.



“[The results] show the great potential of the painless, applicator-free microneedle patch technology platform that Micron is building upon to improve delivery of drugs and vaccines,” stated Devin McAllister, VP R&D Micron.



The first-in-humans, Phase 1 clinical trial enrolled 100 subjects and investigated the safety, immunogenicity and acceptability of a seasonal flu vaccine delivered either by microneedle patch or by standard hypodermic needle and syringe. The study also compared the ability of study participants to selfadminister the microneedle patches.



The results showed that vaccination by microneedle patch was safe, well tolerated by study participants and generated an immune response that was at least as strong as with the standard intramuscular injection. Moreover, subjects overwhelmingly (70%) preferred the microneedle patch over the needle and syringe as their future vaccination method. The study also showed that participants could self-administer the patch.



The microneedle patch technology used in the study was developed at Georgia Tech in the laboratory of Mark Prausnitz, Regents’ Professor of Chemical and Biomolecular Engineering and is now being licensed and developed for commercialization by Micron. “With the microneedle patch, you could pick it up at the store and take it home, put it on your skin for a few minutes, peel it off and dispose of it safely, because the microneedles have dissolved away,” Prausnitz said. "The patches can also be stored outside the refrigerator, so you could even mail them to people.”