Getting an injection is on the bottom of everybody’s list of favorite things, but now a more bearable alternative is another step closer to reality. In human clinical trials, painless Microneedle Patches have been found to be just as effective at delivering flu vaccines, and are easier to administer, transport, store and dispose of than regular needles.Despite the recommendation of universal flu vaccination, influenza continues to be a major cause of illness leading to significant morbidity and mortality,” says Nadine Rouphael, first author of the study 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. The clinical trials began in June 2015 with 100 participants aged between 18 and 49, who hadn’t received a flu shot in the past year. They were divided randomly into four groups: one received Microneedle Patch vaccines from a doctor, others applied it themselves, some were given a standard flu shot by way of injection, and a fourth group were given a placebo patch.
The study reported that the antibody responses were very similar across all three non-placebo groups. The microneedle patch performed about the same as an injection, regardless of whether the patient had administered it themselves or had a doctor do it. Over 70 percent of the participants who received the patch said they would prefer it over an injection in future.
There were no adverse effects either, apart from some faint redness of the skin around the patch site, and some mild itching for a couple of days. The team also found that the drugs in the patch could stay viable for over a year, without the need for refrigeration.Encouraged by the success of this first trial, the team hopes the next phase will be underway soon. In future, vaccines against other diseases like measles, rubella and polio could be administered via microneedle patch.
“It’s very gratifying and exciting to have these patches tested in a clinical trial, and with a result that turned out so well,” says Prausnitz. “We now need to follow this study with a phase II clinical trial involving more people, and we hope that will happen soon.”