{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T15:40:30Z","timestamp":1787586030459,"version":"build-2736575974"},"reference-count":33,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2023,3,14]],"date-time":"2023-03-14T00:00:00Z","timestamp":1678752000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Ministry of Health, Labour, and Welfare","award":["JPMH20HA2005"],"award-info":[{"award-number":["JPMH20HA2005"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Life"],"abstract":"<jats:p>Monkeypox (mpox) is an acute exanthematous disease caused by the monkeypox virus (MPXV). Since May 2022, patients with mpox have been reported worldwide, mainly in Europe and the Americas. In Japan, LC16\u201dKMB,\u201d which is a smallpox vaccine derived from a dried cell culture, against mpox, has been approved. Although inoculation with a smallpox vaccine has been recommended to prevent MPXV infection, the immunogenicity of the smallpox vaccine against the MPXV is unclear, and information regarding postvaccination safety is scarce. We present the protocol for a single-arm open-label study to investigate the immunogenicity and safety of LC16\u201dKMB\u201d against the MPXV in healthy Japanese adults. The primary endpoint is the seroconversion rate of neutralizing antibodies against the MPXV on postvaccination day 28. The secondary endpoints are the seroconversion rates against the MPXV on postvaccination days 14 and 168; the seroconversion rates against the vaccinia virus on postvaccination days 14, 28, and 168; the incidence of mpox until day 168; and adverse and serious adverse events until postvaccination days 28 and 168. These results will pave the way for larger comparative studies using other smallpox vaccines to evaluate the test vaccine\u2019s safety and efficacy in preventing mpox.<\/jats:p>","DOI":"10.3390\/life13030787","type":"journal-article","created":{"date-parts":[[2023,3,15]],"date-time":"2023-03-15T06:36:36Z","timestamp":1678862196000},"page":"787","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0093-2540","authenticated-orcid":false,"given":"Noriko","family":"Tomita","sequence":"first","affiliation":[{"name":"Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eriko","family":"Morino","sequence":"additional","affiliation":[{"name":"Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junko","family":"Terada-Hirashima","sequence":"additional","affiliation":[{"name":"Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukari","family":"Uemura","sequence":"additional","affiliation":[{"name":"Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sho","family":"Saito","sequence":"additional","affiliation":[{"name":"Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3165-9062","authenticated-orcid":false,"given":"Tetsuya","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0434-4842","authenticated-orcid":false,"given":"Nobumasa","family":"Okumura","sequence":"additional","affiliation":[{"name":"Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haruka","family":"Iwasaki","sequence":"additional","affiliation":[{"name":"Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2576-9735","authenticated-orcid":false,"given":"Hideki","family":"Ebihara","sequence":"additional","affiliation":[{"name":"National Institute of Infectious Disease, Tokyo 162-8640, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5745-8413","authenticated-orcid":false,"given":"Masayuki","family":"Shimojima","sequence":"additional","affiliation":[{"name":"National Institute of Infectious Disease, Tokyo 162-8640, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wataru","family":"Sugiura","sequence":"additional","affiliation":[{"name":"Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norio","family":"Ohmagari","sequence":"additional","affiliation":[{"name":"Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mugen","family":"Ujiie","sequence":"additional","affiliation":[{"name":"Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo 162-8655, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,3,14]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1086\/427805","article-title":"Evaluation of human-to-human transmission of monkeypox from infected patients to health care workers","volume":"40","author":"Fleischauer","year":"2005","journal-title":"Clin. 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