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.
The patches were designed at Georgia Institute of Technology, which conducted the study in collaboration with Emory University.
“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.
