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Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan
Despite the initial success of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in prevention of symptomatic and severe diseases, booster vaccination has become increasingly important with the advent of variants with immune-escaping capacity. Herein, we report the safety and imm...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10562875/ https://www.ncbi.nlm.nih.gov/pubmed/37822891 http://dx.doi.org/10.1016/j.jvacx.2023.100390 |
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author | Sonoyama, Takuhiro Kamitani, Akari Shibata, Risa Y. Seki, Naomi M. Omoto, Shinya Igarashi, Kenji Ariyasu, Mari |
author_facet | Sonoyama, Takuhiro Kamitani, Akari Shibata, Risa Y. Seki, Naomi M. Omoto, Shinya Igarashi, Kenji Ariyasu, Mari |
author_sort | Sonoyama, Takuhiro |
collection | PubMed |
description | Despite the initial success of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in prevention of symptomatic and severe diseases, booster vaccination has become increasingly important with the advent of variants with immune-escaping capacity. Herein, we report the safety and immunogenicity of S-268019-b, comprising SARS-CoV-2 spike protein and a squalene-based adjuvant, as a booster dose. We performed an interim analysis of an open-label, Phase 3 study data until Day 29 following S-268019-b booster in Japanese adults (aged 20–64 years) who had completed primary vaccination with mRNA-1273 and in Japanese elderly (aged ≥ 65 years) who had completed primary vaccination with mRNA-1273 or BNT162b2. Reactogenicity was mild in most participants; no serious treatment-related adverse events were noted. S-268019-b enhanced SARS-CoV-2 neutralizing antibodies, immunoglobulin G antibodies, and predominant T-helper 1-mediated immune reaction in all cohorts, regardless of age, in Japanese participants with prior vaccination with mRNA vaccines. |
format | Online Article Text |
id | pubmed-10562875 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-105628752023-10-11 Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan Sonoyama, Takuhiro Kamitani, Akari Shibata, Risa Y. Seki, Naomi M. Omoto, Shinya Igarashi, Kenji Ariyasu, Mari Vaccine X Regular paper Despite the initial success of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in prevention of symptomatic and severe diseases, booster vaccination has become increasingly important with the advent of variants with immune-escaping capacity. Herein, we report the safety and immunogenicity of S-268019-b, comprising SARS-CoV-2 spike protein and a squalene-based adjuvant, as a booster dose. We performed an interim analysis of an open-label, Phase 3 study data until Day 29 following S-268019-b booster in Japanese adults (aged 20–64 years) who had completed primary vaccination with mRNA-1273 and in Japanese elderly (aged ≥ 65 years) who had completed primary vaccination with mRNA-1273 or BNT162b2. Reactogenicity was mild in most participants; no serious treatment-related adverse events were noted. S-268019-b enhanced SARS-CoV-2 neutralizing antibodies, immunoglobulin G antibodies, and predominant T-helper 1-mediated immune reaction in all cohorts, regardless of age, in Japanese participants with prior vaccination with mRNA vaccines. Elsevier 2023-09-18 /pmc/articles/PMC10562875/ /pubmed/37822891 http://dx.doi.org/10.1016/j.jvacx.2023.100390 Text en © 2023 The Authors https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Regular paper Sonoyama, Takuhiro Kamitani, Akari Shibata, Risa Y. Seki, Naomi M. Omoto, Shinya Igarashi, Kenji Ariyasu, Mari Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan |
title | Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan |
title_full | Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan |
title_fullStr | Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan |
title_full_unstemmed | Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan |
title_short | Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan |
title_sort | safety and immunogenicity of a booster dose of s-268019-b: interim findings of a phase 3, open-label clinical study in japan |
topic | Regular paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10562875/ https://www.ncbi.nlm.nih.gov/pubmed/37822891 http://dx.doi.org/10.1016/j.jvacx.2023.100390 |
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