MedicalResearch.com Interview with:
Dr Nadine G Rouphael MD
Associate Professor of Medicine, Emory University
Director of the VTEU and HIPC networks at the
Hope Clinic of the Emory Vaccine Center
Decatur GA 30030, USA
MedicalResearch.com: What is the background for this new technology and study? What are the main findings?
Response: Different groups including a group of researchers at Georgia Tech have been working on the microneedle technology for more than 20 years. The dissolvable microneedle patches are already used in several cosmetic products and drugs. However, vaccination with microneedle patches has been studied mostly in animals.
Our phase 1 trial published this week in The Lancet showed that vaccination with the microneedle patches was safe, with no related serious adverse events reported. Local skin reactions to the patches were mostly mild itching and faint redness that lasted two to three days. No new chronic medical illnesses or influenza-like illnesses were reported with either the patch or the injection groups. Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. When asked after immunization, more than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The advantages of the microneedle patches once confirmed with larger studies are numerous. The dissolvable microneedle patches could simplify delivery of influenza vaccines, thereby enabling distribution and storage outside the cold chain, disposal as non-sharps waste, and possible self-administration. These advances could reduce the cost of influenza vaccination and increase patient access to influenza vaccine, thereby increasing vaccination coverage and protection from influenza morbidity and mortality.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future research with the microneedle patches should look at a larger group of subjects to confirm safety and efficacy, should look at the extreme of ages (children and elderly) and test other vaccines as well.
MedicalResearch.com: Is there anything else you would like to add?
Response: This is exciting and could be a game changer in the vaccine world. The work is the result of the great collaboration between GA tech and Emory University. I would like to thank our sponsor the National Institutes of Health, the participants who enrolled in the study and also the wonderful staff of the Emory Hope Clinic lead by Professor Mark Mulligan and the lead coordinators Michele Paine and Regina Mosley, without them the study would not have been possible.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial
Published online: June 27, 2017
Nadine G Rouphael, Michele Paine, Regina Mosley, Sebastien Henry, Devin V McAllister, Haripriya Kalluri, Winston Pewin, Paula M Frew, Tianwei Yu, Natalie J Thornburg, Sarah Kabbani, Lilin Lai, Elena V Vassilieva, Ioanna Skountzou, Richard W Compans, Mark J Mulligan, Mark R Prausnitz
for the TIV-MNP 2015 Study Group
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