June 29 (UPI) -- Researchers have successfully completed the first clinical trial of a patch that delivers the influenza vaccine through microneedles.
Only 40 percent of adults in the United States get influenza vaccines each year, despite the prevalence and potential severity of the illness.
The Phase 1 clinical trial was conducted by Emory University and the Georgia Institute of Technology on 100 participants beginning in June 2015.
The trial, which is detailed in a study published June 27 in The Lancet, found the flu vaccine administered using a skin patch with dissolvable microneedles was just as effective at providing immunity against the flu as the shot.
Clinical trial participants reported the patch was safe and well-tolerated, and was more cost-effective because it can be easily self-administered.
The patch can also be transported and stored without refrigeration and is easily disposed of without sharps waste because the microneedles are dissolvable.
"Despite the recommendation of universal flu vaccination, influenza continues to be a major cause of illness leading to significant morbidity and mortality," Dr. Nadine Rouphael, associate professor of medicine at Emory University School of Medicine, said in a press release. "Having the option of a flu vaccine that can be easily and painlessly self-administered could increase coverage and protection by this important vaccine."
For the trial, participants age 18 to 49 were randomized into four groups -- a vaccine with microneedle patch administered by a healthcare provider, a self-administered vaccine with microneedle patch, a vaccine with injection given by a healthcare provider and a placebo microneedle patch administered by a healthcare provider.
Researchers found antibody responses from the vaccine were the same in the microneedle patch and the intramuscular injection, and were still present after six months. There was also no significant difference between the self-administered patch and the heathcare provider administered patch as far as effectiveness.
"People have a lot of reasons for not getting flu vaccinations," said Dr. Mark Prausnitz, Georgia Tech Regents professor of chemical and biomolecular engineering. "One of the main goals of developing the microneedle patch technology was to make vaccines accessible to more people. Traditionally, if you get an influenza vaccine you need to visit a health care professional who will administer the vaccine using a hypodermic needle. The vaccine is stored in the refrigerator, and the used needle must be disposed of in a safe manner."
"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. The patches can also be stored outside the refrigerator, so you could even mail them to people."