From Georgia Tech News Center Health and
Patches for Flu Vaccination Successful in First Human Clinical Trial
By Holly Korschun | June 27, 2017 • Atlanta, GA
Despite the potentially severe consequences of illness
and even death, only about 40 percent of adults in the United States receive
flu shots each year; however, researchers believe a new self-administered,
painless vaccine skin patch containing microscopic needles could significantly
increase the number of people who get vaccinated.
A phase I clinical trial conducted by Emory University in
collaboration with researchers from the Georgia Institute of Technology has
found that influenza vaccination using Band-Aid-like patches with dissolvable
microneedles was safe and well-tolerated by study participants, was just as
effective in generating immunity against influenza, and was strongly preferred
by study participants over vaccination with a hypodermic needle and syringe.
The microneedle patch vaccine could also save money because it is easily
self-administered, could be transported and stored without refrigeration, and
is easily disposed of after use without sharps waste.
Results of the study are published June 27, 2017 in the
medical journal The Lancet. The research
was supported by the National Institute of Biomedical Imaging and
Bioengineering of the National Institutes of Health.
“Despite the recommendation of universal flu vaccination,
influenza continues to be a major cause of illness leading to significant
morbidity and mortality,” said first author Nadine Rouphael, M.D., associate
professor of medicine (infectious diseases) at Emory University School of
Medicine 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 first-in-human clinical trial of the flu vaccine
patches began in June 2015 with 100 participants aged 18-49 who were healthy
and who had not received the influenza vaccine during the 2014-15 flu season.
The study was conducted at the Hope Clinic of the Emory Vaccine Center in
Atlanta. The study was carried out under an Investigational New Drug Application
authorized by the FDA.
Participants were randomized into four groups: (1)
vaccination with microneedle patch given by a health care provider; (2)
vaccination with microneedle patch self-administered by study participants; (3)
vaccination with intramuscular injection given by a health care provider; and
(4) placebo microneedle patch given by a health care provider.
“People have a lot of reasons for not getting flu
vaccinations,” said senior co-author Mark Prausnitz, Ph.D., Georgia Tech
Regents professor of chemical and biomolecular engineering. “One of the main
goals of developing the microneedle patch technology was to make vaccines
accessible to more people. Traditionally, if you get an influenza vaccine you
need to visit a health care professional who will administer the vaccine using
a hypodermic needle. The vaccine is stored in the refrigerator, and the used
needle must be disposed of in a safe manner. With the microneedle patch, you
could pick it up at the store and take it home, put it on your skin for a few
minutes, peel it off and dispose of it safely, because the microneedles have
dissolved away. The patches can also be stored outside the refrigerator, so you
could even mail them to people.”
Study results showed that vaccination with the
microneedle patches was safe, with no adverse events reported. Local skin
reactions to the patches were mostly faint redness and mild itching 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. More than 70 percent of patch recipients reported they would prefer
patch vaccination over injection or intranasal vaccination for future
No significant difference was seen between the doses of
vaccine delivered by the health care workers and the volunteers who
self-administered the patches, showing that participants were able to correctly
self-administer the patch. After vaccination, imaging of the used patches found
that the microneedles had dissolved in the skin, suggesting that the used
patches could be safely discarded as non-sharps waste. The vaccines remained
potent in the patches without refrigeration for at least one year.
The microneedle patches used in the study were designed
at Georgia Tech and manufactured by the Global Center for Medical Innovation in
Prausnitz has been working for many years to develop the
microneedle patch technology. “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.”
The researchers also are working to develop microneedle
patches for use with other vaccines, including measles, rubella and polio.
“From the very start of this project,” said Prausnitz,
“our team at Georgia Tech has been working with the Emory team to develop the
microneedle patches, and the success of the project has been due to the strong
collaboration between Georgia Tech engineers and the bioscience and medical
experts at Emory.” Prausnitz holds the J. Erskine Love Jr. Chair in the School
of Chemical and Biomolecular Engineering.
The authors summarized: “Influenza vaccination using
microneedle patches is well-tolerated, well-accepted, and results in robust
immunologic responses, whether administered by health care workers or by the
participants themselves. These results provide evidence that microneedle patch
vaccination is an innovative new approach with the potential to improve current
vacination coverage and reduce immunization costs.”
In addition to Rouphael and Prausnitz, other study
authors include co-senior author Mark J. Mulligan, M.D., executive director of
the Hope Clinic of the Emory Vaccine Center; Emory researchers Michele Paine,
Regina Mosley, Paula M. Frew, Tianwei Yu, Natalie J. Thornburg, Sarah Kabbani,
Lilin Lai, Elena V. Vassilieva, Ioanna Skountzou, and Richard W. Compans; and
Georgia Tech researchers Sebastien Henry, Devin V. McAllister, Haripriya
Kalluri, and Winston Pewin.
This study was funded by a grant from the National
Institute of Biomedical Imaging and Bioengineering of the National Institutes
of Health (U01 EB012495). One of the researchers received support through a
training grant from the National Institute of Allergy and Infectious Diseases
(T32 AI074492). The Georgia Research Alliance provided instrumentation support.
The content is solely the responsibility of the authors and does not
necessarily represent the official views of the sponsoring agencies.
Prausnitz has co-founded a company called Micron
Biomedical that is licensing patents related to this study. Micron Biomedical
is poised to move the microneedle patch technology forward, bring it further
into clinical trials, commercialize it and ultimately make it available to
Prausnitz and several other Georgia Tech researchers are
inventors of the microneedle patch technology used in this study and have
ownership interest in Micron Biomedical. They are entitled to royalties derived
from Micron Biomedical’s future sales of products related to the research.
These potential conflicts of interest have been disclosed and are overseen by
Georgia Institute of Technology and Emory University.
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Writer: Holly Korschun