Study Shows Microneedle Patch Influenza Vaccine Is Effective and Painless

A new study shows that microneedle patches provide an alternative to conventional needle-and-syringe immunization, potentially offering improved immunogenicity, simplicity, cost-effectiveness, acceptability and safety. In the Phase I randomized, partly blinded, placebo-controlled clinical trial, conducted at Emory University in Atlanta, Ga., 100 nonpregnant women aged 18 years to 49 years were randomly assigned to four groups. One quarter of the adults received a single dose of inactivated influenza vaccine by microneedle patch by a healthcare worker; another quarter received a single dose of inactivated influenza vaccine by intramuscular (IM) injection by a healthcare worker; another quarter received a placebo by microneedle patch by a healthcare worker; and the last quarter received a single dose of inactivated influenza vaccine by microneedle patch that was self-administered by participants. Acceptability of the vaccine was rated slightly higher for the two microneedle patch vaccine groups (4.5 to 4.8 on a 5-point scale) than the conventional IM injection group (4.4 out of 5). Ninety-six percent of subjects who received the patch reported no pain, versus 82 percent of subjects receiving the IM injection. However, erythema (40 percent versus zero) and itching/pruritis (82 percent versus 16 percent) were reported much more frequently by subjects in the patch groups than the IM injection group.

The “peel-and-stick” microneedle patch penetrates the upper layer of the skin, and the tiny vaccine-filled needles dissolve rapidly as they deliver the vaccine. It was developed by lead investigator Mark Prausnitz, PhD, and his team at the Laboratory for Drug Delivery at the Georgia Institute of Technology and is licensed for development and commercialization to Micron Biomedical.