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Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study
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”KMB,” which is a smallpox vaccine derived from a dried cell culture, against mpox, has been appr...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10059741/ https://www.ncbi.nlm.nih.gov/pubmed/36983942 http://dx.doi.org/10.3390/life13030787 |
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author | Tomita, Noriko Morino, Eriko Terada-Hirashima, Junko Uemura, Yukari Shimizu, Yosuke Saito, Sho Suzuki, Tetsuya Okumura, Nobumasa Iwasaki, Haruka Ebihara, Hideki Shimojima, Masayuki Sugiura, Wataru Ohmagari, Norio Ujiie, Mugen |
author_facet | Tomita, Noriko Morino, Eriko Terada-Hirashima, Junko Uemura, Yukari Shimizu, Yosuke Saito, Sho Suzuki, Tetsuya Okumura, Nobumasa Iwasaki, Haruka Ebihara, Hideki Shimojima, Masayuki Sugiura, Wataru Ohmagari, Norio Ujiie, Mugen |
author_sort | Tomita, Noriko |
collection | PubMed |
description | 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”KMB,” 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”KMB” 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’s safety and efficacy in preventing mpox. |
format | Online Article Text |
id | pubmed-10059741 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-100597412023-03-30 Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study Tomita, Noriko Morino, Eriko Terada-Hirashima, Junko Uemura, Yukari Shimizu, Yosuke Saito, Sho Suzuki, Tetsuya Okumura, Nobumasa Iwasaki, Haruka Ebihara, Hideki Shimojima, Masayuki Sugiura, Wataru Ohmagari, Norio Ujiie, Mugen Life (Basel) Article 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”KMB,” 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”KMB” 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’s safety and efficacy in preventing mpox. MDPI 2023-03-14 /pmc/articles/PMC10059741/ /pubmed/36983942 http://dx.doi.org/10.3390/life13030787 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Tomita, Noriko Morino, Eriko Terada-Hirashima, Junko Uemura, Yukari Shimizu, Yosuke Saito, Sho Suzuki, Tetsuya Okumura, Nobumasa Iwasaki, Haruka Ebihara, Hideki Shimojima, Masayuki Sugiura, Wataru Ohmagari, Norio Ujiie, Mugen Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study |
title | Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study |
title_full | Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study |
title_fullStr | Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study |
title_full_unstemmed | Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study |
title_short | Evaluating the Immunogenicity and Safety of a Smallpox Vaccine to Monkeypox in Healthy Japanese Adults: A Single-Arm Study |
title_sort | evaluating the immunogenicity and safety of a smallpox vaccine to monkeypox in healthy japanese adults: a single-arm study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10059741/ https://www.ncbi.nlm.nih.gov/pubmed/36983942 http://dx.doi.org/10.3390/life13030787 |
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