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Painless microneedle influenza vaccine patches effective in early-phase trial
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Patches that deliver influenza vaccine produced robust immune responses in a phase 1 clinical trial and were preferred over traditional injection by most patients who used them, researchers reported.
The patches, equipped with microneedles that dissolve in minutes, could improve and lower the cost of vaccination coverage, the researchers wrote in The Lancet.
“Despite the recommendation for adults and children to receive a flu shot, many people remain unvaccinated,” researcher Nadine Rouphael, MD, associate professor of medicine in the department of infectious diseases at Emory University, told Infectious Disease News. “The microneedle patches could potentially simplify the delivery of flu vaccines. We found that the vaccine was stable outside the cold chain, meaning that it could be stored on a pharmacy shelf. The patch could also be safely applied by participants themselves, meaning we could envisage vaccination at home, in the workplace or even via mail distribution.”
Each patch holds 100 water-soluble needles that slightly penetrate the skin. After the needle heads dissolve and release the vaccine, the patch is peeled off and discarded.
To test the patches, the researchers at the Georgia Institute of Technology and Emory University recruited 100 healthy adults who had not received a 2014-2015 influenza shot to participate in a partly blinded, placebo-controlled trial between June 23 and Sept. 25, 2015.
The participants were randomly assigned 1:1:1:1 to either administer the microneedle patch themselves, have a health care worker administer the patch, receive an intramuscular injection of vaccine or have a health care worker administer a placebo patch. Those who were inoculated were given inactivated influenza vaccine doses for the H1N1, H3N2 and B strains.
At 28 days after vaccination, the geometric mean titers (GMT) from the vaccine patches administered by health care workers were similar to those from the intramuscular injections, the researchers said. For the patches and injections, respectively, the GMT were 1,197 (95% CI, 855-1,675) and 997 (95% CI, 703-1,415; P = 0.5) for the H1N1 strain, 287 (95% CI, 192-430) and 223 (95% CI, 160-312; P = 0.4) for the H3N2 strain, 126 (95% CI, 86-184) and 94 (95% CI, 73-122; P = .06) for the B strain.
The GMT in participants who self-administered the patches were also similar, the researchers said (P > .05). Seroconversion percentages from the patches were significantly higher than those in participants who received placebos (P < .0001) and similar to those for intramuscular injections (P > .01).
Among participants receiving intramuscular injections, 15 (60%) reported tenderness, and 11 (44%) reported pain.
Among participants either administering the patches themselves or having them administered by health care workers, 33 (66%) reported tenderness, 20 (40%) reported erythema and 41 (82%) reported pruritus.
The researchers said that if their findings are confirmed in larger clinical trials, the patches could be a vital asset, Rouphael said.
“Microneedle patches are timely, as we are preparing for an influenza pandemic,” she explained. “Each one of us could self-administer the vaccine, increasing the speed of vaccination by removing the bottleneck of health care worker availability. It could reduce the risk of transmission by avoiding concentration of patients at the clinics.” – by Joe Green
Disclosure: Rouphael reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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