Dissolvable microneedle patches that deliver the flu vaccine could provide a safe and cost-effective alternative to traditional immunization methods, according to the results from a Phase I trial published in The Lancet this week.
The study enrolled adults ages 18 to 49 and randomly assigned them to receive a single dose of inactivated flu vaccine via microneedle patch, intramuscular injection or a placebo by microneedle patch – all administered by a healthcare practitioner. The 4th group self-administered an inactivated flu vaccine using a microneedle patch.
The study’s primary safety outcome endpoints were the rate of product-related serious adverse events within 180 days and solicited injection site and systemic reactogenicity from days 0 to 7.
Immunogenicity outcomes included anitbody titres at day 28 and the percentages of seroconversion and seroprotection, according to the researchers.
Among the 100 participants, there were no treatment-related serious adverse events and no new-onset chronic illnesses. Also, the microneedle patch and the intramuscular injection performed similarly at day 28 for the H1N1 strain, the H3N2 strain and the B strain. Similar results were reported for the participants who self-administered the vaccine using a 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. We now need to follow this study with a Phase II clinical trial involving more people, and we hope that will happen soon,” senior co-author Mark Prausnitz said in prepared remarks.
Prausnitz co-founded Micron Biomedical that is licensing patents related to this study, the university reported.