{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T20:55:41Z","timestamp":1790456141901,"version":"4.1.0"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Micron Biomedical, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Objectives<\/jats:title>\n                    <jats:p>Dissolving microneedle patches (dMNPs) are a novel vaccine delivery method that may enhance acceptability and uptake. However, more data on their use in children are needed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a single-center, unblinded study at Emory University to evaluate the safety, reactogenicity, and acceptability of placebo dMNPs applied to the skin of healthy infants and children. Each participant received a dMNP on day 1, and if well tolerated, could receive second and third dMNPs on day 8 applied to different anatomical sites. Solicited local and systemic adverse events (AEs) were collected for 7\u00a0days following dMNP application. Unsolicited AEs, serious adverse events (SAEs), and new-onset medical conditions (NOMCs) were collected through the study. Parents were surveyed to assess dMNP acceptability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Between August 2018 and April 2019, 25 participants 6\u00a0weeks to 24\u00a0months of age were enrolled. All the participants received one placebo dMNP applied to the wrist, and 23\/25 received second and third placebo dMNPs. Overall, dMNPs were safe and well tolerated, with minimal local reactogenicity. Systemic reactogenicity was generally mild but grade 2 and 3 irritability were observed. There were no SAEs or NOMCs following the application of any dMNP. Parental acceptability of dMNPs was high, and parents reported that having a dMNP administered by a healthcare worker would increase their likelihood of obtaining a recommended vaccine for their child.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Placebo dMNPs were safe and well tolerated in infants and young children. These data support the continued development of pediatric dMNP vaccines.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jpids\/piag007","type":"journal-article","created":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T12:43:23Z","timestamp":1769777003000},"source":"Crossref","is-referenced-by-count":3,"title":["Safety, Reactogenicity, and Acceptability of a Placebo Dissolving Microneedle Patch in Children"],"prefix":"10.1093","volume":"15","author":[{"given":"Carol M","family":"Kao","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]},{"name":"Department of Pediatrics, Washington University in St Louis , St Louis, MO ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8439-0592","authenticated-orcid":false,"given":"Christina A","family":"Rostad","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]},{"name":"Department of Pediatrics, Children\u2019s Healthcare of Atlanta , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peggy","family":"Kettle","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Tippett","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jumi","family":"Yi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]},{"name":"Global Regulatory and Clinical Safety, Merck , Rahway, NJ ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inci","family":"Yildirim","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]},{"name":"Department of Pediatrics, Section of Infectious Diseases and Global Health, Yale University School of Medicine , New Haven, CT ,","place":["United States"]},{"name":"Department of Epidemiology of Microbiological Diseases, Yale University School of Medicine , New Haven, CT ,","place":["United States"]},{"name":"Yale Institute of Global Health, Yale University , New Haven, CT ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathy","family":"Stephens","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chelsea","family":"Korski","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian P","family":"Pollack","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Atlanta Veterans Affairs Health Care System , Decatur, GA ,","place":["United States"]},{"name":"Department of Dermatology, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark R","family":"Prausnitz","sequence":"additional","affiliation":[{"name":"Micron Biomedical, Inc. , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devin V","family":"McAllister","sequence":"additional","affiliation":[{"name":"Micron Biomedical, Inc. , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastien","family":"Henry","sequence":"additional","affiliation":[{"name":"Micron Biomedical, Inc. , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2512-7919","authenticated-orcid":false,"given":"Nadine","family":"Rouphael","sequence":"additional","affiliation":[{"name":"Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan J","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine , Atlanta, GA ,","place":["United States"]},{"name":"Department of Pediatrics, Children\u2019s Healthcare of Atlanta , Atlanta, GA ,","place":["United States"]},{"name":"Moderna Inc. , Connecticut, MA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,2,2]]},"reference":[{"key":"2026022001413612000_ref1","article-title":"Facts and figures","author":"Gavi, the Vaccine Alliance"},{"key":"2026022001413612000_ref2","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1080\/14760584.2020.1732215","article-title":"The potential role of using vaccine patches to induce immunity: platform and pathways to innovation and commercialization","volume":"19","author":"Badizadegan","year":"2020","journal-title":"Expert Rev Vaccines"},{"key":"2026022001413612000_ref3","doi-asserted-by":"publisher","first-page":"4807","DOI":"10.1016\/j.vaccine.2012.05.011","article-title":"Survey of the prevalence of immunization non-compliance due to needle fears in children and adults","volume":"30","author":"Taddio","year":"2012","journal-title":"Vaccine"},{"key":"2026022001413612000_ref4","doi-asserted-by":"publisher","first-page":"1547","DOI":"10.1016\/j.addr.2012.04.005","article-title":"Microneedles for drug and vaccine delivery","volume":"64","author":"Kim","year":"2012","journal-title":"Adv Drug Deliv Rev"},{"key":"2026022001413612000_ref5","doi-asserted-by":"publisher","first-page":"3396","DOI":"10.1016\/j.vaccine.2012.11.027","article-title":"Dose sparing and enhanced immunogenicity of inactivated rotavirus vaccine administered by skin vaccination using a microneedle patch","volume":"31","author":"Moon","year":"2013","journal-title":"Vaccine"},{"key":"2026022001413612000_ref6","doi-asserted-by":"crossref","first-page":"868","DOI":"10.1007\/s11095-015-1833-9","article-title":"Enhanced stability of inactivated influenza vaccine encapsulated in dissolving microneedle patches","volume":"33","author":"Chu","year":"2016","journal-title":"Pharm Res"},{"key":"2026022001413612000_ref7","doi-asserted-by":"crossref","first-page":"1705","DOI":"10.3389\/fimmu.2018.01705","article-title":"Enhanced immune responses conferring cross-protection by skin vaccination with a tri-component influenza vaccine using a microneedle patch","volume":"9","author":"Zhu","year":"2018","journal-title":"Front Immunol"},{"key":"2026022001413612000_ref8","doi-asserted-by":"publisher","first-page":"135","DOI":"10.1016\/j.jconrel.2015.11.019","article-title":"Microneedle patches for vaccination in developing countries","volume":"240","author":"Arya","year":"2016","journal-title":"J Control Release"},{"key":"2026022001413612000_ref9","doi-asserted-by":"publisher","first-page":"1856","DOI":"10.1016\/j.vaccine.2014.01.076","article-title":"Microneedle patches: usability and acceptability for self-vaccination against influenza","volume":"32","author":"Norman","year":"2014","journal-title":"Vaccine"},{"key":"2026022001413612000_ref10","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1016\/S0140-6736(17)30575-5","article-title":"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","volume":"390","author":"Rouphael","year":"2017","journal-title":"Lancet"},{"key":"2026022001413612000_ref11","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines7040189","article-title":"Efficient delivery of dengue virus subunit vaccines to the skin by microprojection arrays","volume":"7","author":"Muller","year":"2019","journal-title":"Vaccines (Basel)"},{"key":"2026022001413612000_ref12","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1093\/infdis\/jiy139","article-title":"A microneedle patch for measles and rubella vaccination is immunogenic and protective in infant rhesus macaques","volume":"218","author":"Joyce","year":"2018","journal-title":"J Infect Dis"},{"key":"2026022001413612000_ref13","doi-asserted-by":"publisher","first-page":"1879","DOI":"10.1016\/S0140-6736(24)00532-4","article-title":"A measles and rubella vaccine microneedle patch in The Gambia: a phase 1\/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial","volume":"403","author":"Adigweme","year":"2024","journal-title":"Lancet"},{"key":"2026022001413612000_ref14","doi-asserted-by":"publisher","first-page":"4435","DOI":"10.1016\/j.vaccine.2019.02.079","article-title":"End-user acceptability study of the nanopatch; a microarray patch (MAP) for child immunization in low and middle-income countries","volume":"37","author":"Guillermet","year":"2019","journal-title":"Vaccine"},{"key":"2026022001413612000_ref15","doi-asserted-by":"crossref","first-page":"4896","DOI":"10.1016\/j.vaccine.2017.07.083","article-title":"Acceptability of microneedle-patch vaccines: a qualitative analysis of the opinions of parents","volume":"35","author":"Marshall","year":"2017","journal-title":"Vaccine"},{"key":"2026022001413612000_ref16","doi-asserted-by":"crossref","first-page":"676","DOI":"10.1016\/j.jconrel.2021.08.012","article-title":"Immediate detachment of microneedles by interfacial fracture for sustained delivery of a contraceptive hormone in the skin","volume":"337","author":"Lee","year":"2021","journal-title":"J Control Release"},{"key":"2026022001413612000_ref17","doi-asserted-by":"publisher","first-page":"573","DOI":"10.1021\/acs.molpharmaceut.4c01207","article-title":"Highly water-soluble microneedle patch for short wear time and rapid drug delivery","volume":"22","author":"Wood-Yang","year":"2025","journal-title":"Mol Pharm"},{"key":"2026022001413612000_ref18","article-title":"Immunization coverage","author":"World Health Organization"},{"key":"2026022001413612000_ref19","doi-asserted-by":"publisher","first-page":"68","DOI":"10.1001\/jamapediatrics.2021.4251","article-title":"Association of the COVID-19 pandemic with routine childhood vaccination rates and proportion up to date with vaccinations across 8 US health Systems in the Vaccine Safety Datalink","volume":"176","author":"DeSilva","year":"2022","journal-title":"JAMA Pediatr"},{"key":"2026022001413612000_ref20","doi-asserted-by":"publisher","first-page":"561","DOI":"10.15585\/mmwr.mm7116a1","article-title":"Vaccination coverage with selected vaccines and exemption rates among children in kindergarten - United States, 2020-21 school year","volume":"71","author":"Seither","year":"2022","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2026022001413612000_ref21","doi-asserted-by":"publisher","first-page":"522","DOI":"10.1016\/S0140-6736(21)01337-4","article-title":"Estimating global and regional disruptions to routine childhood vaccine coverage during the COVID-19 pandemic in 2020: a modelling study","volume":"398","author":"Causey","year":"2021","journal-title":"Lancet"},{"key":"2026022001413612000_ref22","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1038\/s41541-021-00353-0","article-title":"Immunologic mechanisms of seasonal influenza vaccination administered by microneedle patch from a randomized phase I trial","volume":"6","author":"Rouphael","year":"2021","journal-title":"NPJ Vaccines"},{"key":"2026022001413612000_ref23","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics16121631","article-title":"Development and evaluation of five-in-one vaccine microneedle Array patch for diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b: immunological efficacy and long-term stability","volume":"16","author":"Choi","year":"2024","journal-title":"Pharmaceutics"},{"key":"2026022001413612000_ref24","doi-asserted-by":"publisher","DOI":"10.1007\/s13346-025-01964-z","article-title":"Development of a microneedle patch for delivery of mRNA-lipid nanoparticles","author":"Sakers","year":"2025","journal-title":"Drug Deliv Transl Res"},{"key":"2026022001413612000_ref25","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1007\/s40268-016-0144-x","article-title":"Assessing the potential cost-effectiveness of microneedle patches in childhood measles vaccination programs: the case for further research and development","volume":"16","author":"Adhikari","year":"2016","journal-title":"Drugs R D"},{"key":"2026022001413612000_ref26","doi-asserted-by":"publisher","first-page":"4727","DOI":"10.1016\/j.vaccine.2015.02.076","article-title":"An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine","volume":"33","author":"Lee","year":"2015","journal-title":"Vaccine"},{"key":"2026022001413612000_ref27","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines9040320","article-title":"Dissolvable microneedle patches to enable increased access to vaccines against SARS-CoV-2 and future pandemic outbreaks","volume":"9","author":"O'Shea","year":"2021","journal-title":"Vaccines (Basel)"},{"key":"2026022001413612000_ref28","doi-asserted-by":"crossref","first-page":"127038","DOI":"10.1016\/j.vaccine.2025.127038","article-title":"Perceptions of non-needle-based vaccination devices in the state of Georgia","volume":"55","author":"Melot","year":"2025","journal-title":"Vaccine"}],"container-title":["Journal of the Pediatric Infectious Diseases Society"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jpids\/advance-article-pdf\/doi\/10.1093\/jpids\/piag007\/66706286\/piag007.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jpids\/article-pdf\/15\/2\/piag007\/66706286\/piag007.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jpids\/article-pdf\/15\/2\/piag007\/66706286\/piag007.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T06:41:43Z","timestamp":1771569703000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jpids\/article\/doi\/10.1093\/jpids\/piag007\/8454610"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2]]},"references-count":28,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2,3]]}},"URL":"https:\/\/doi.org\/10.1093\/jpids\/piag007","relation":{},"ISSN":["2048-7207"],"issn-type":[{"value":"2048-7207","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,2]]},"published":{"date-parts":[[2026,2]]},"article-number":"piag007"}}