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Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study
VLPCOV-01 is a lipid nanoparticle-encapsulated self-amplifying RNA (saRNA) vaccine that expresses a membrane-anchored receptor-binding domain (RBD) derived from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. A phase 1 study of VLPCOV-01 is conducted (jRCT2051210164)....
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/PMC10439244/ https://www.ncbi.nlm.nih.gov/pubmed/37586325 http://dx.doi.org/10.1016/j.xcrm.2023.101134 |
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author | Akahata, Wataru Sekida, Takashi Nogimori, Takuto Ode, Hirotaka Tamura, Tomokazu Kono, Kaoru Kazami, Yoko Washizaki, Ayaka Masuta, Yuji Suzuki, Rigel Matsuda, Kenta Komori, Mai Morey, Amber L. Ishimoto, Keiko Nakata, Misako Hasunuma, Tomoko Fukuhara, Takasuke Iwatani, Yasumasa Yamamoto, Takuya Smith, Jonathan F. Sato, Nobuaki |
author_facet | Akahata, Wataru Sekida, Takashi Nogimori, Takuto Ode, Hirotaka Tamura, Tomokazu Kono, Kaoru Kazami, Yoko Washizaki, Ayaka Masuta, Yuji Suzuki, Rigel Matsuda, Kenta Komori, Mai Morey, Amber L. Ishimoto, Keiko Nakata, Misako Hasunuma, Tomoko Fukuhara, Takasuke Iwatani, Yasumasa Yamamoto, Takuya Smith, Jonathan F. Sato, Nobuaki |
author_sort | Akahata, Wataru |
collection | PubMed |
description | VLPCOV-01 is a lipid nanoparticle-encapsulated self-amplifying RNA (saRNA) vaccine that expresses a membrane-anchored receptor-binding domain (RBD) derived from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. A phase 1 study of VLPCOV-01 is conducted (jRCT2051210164). Participants who completed two doses of the BNT162b2 mRNA vaccine previously are randomized to receive one intramuscular vaccination of 0.3, 1.0, or 3.0 μg VLPCOV-01, 30 μg BNT162b2, or placebo. No serious adverse events have been reported. VLPCOV-01 induces robust immunoglobulin G (IgG) titers against the RBD protein that are maintained up to 26 weeks in non-elderly participants, with geometric means ranging from 5,037 (95% confidence interval [CI] 1,272–19,940) at 0.3 μg to 12,873 (95% CI 937–17,686) at 3 μg compared with 3,166 (95% CI 1,619–6,191) with 30 μg BNT162b2. Neutralizing antibody titers against all variants of SARS-CoV-2 tested are induced. VLPCOV-01 is immunogenic following low-dose administration. These findings support the potential for saRNA as a vaccine platform. |
format | Online Article Text |
id | pubmed-10439244 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-104392442023-08-20 Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study Akahata, Wataru Sekida, Takashi Nogimori, Takuto Ode, Hirotaka Tamura, Tomokazu Kono, Kaoru Kazami, Yoko Washizaki, Ayaka Masuta, Yuji Suzuki, Rigel Matsuda, Kenta Komori, Mai Morey, Amber L. Ishimoto, Keiko Nakata, Misako Hasunuma, Tomoko Fukuhara, Takasuke Iwatani, Yasumasa Yamamoto, Takuya Smith, Jonathan F. Sato, Nobuaki Cell Rep Med Article VLPCOV-01 is a lipid nanoparticle-encapsulated self-amplifying RNA (saRNA) vaccine that expresses a membrane-anchored receptor-binding domain (RBD) derived from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. A phase 1 study of VLPCOV-01 is conducted (jRCT2051210164). Participants who completed two doses of the BNT162b2 mRNA vaccine previously are randomized to receive one intramuscular vaccination of 0.3, 1.0, or 3.0 μg VLPCOV-01, 30 μg BNT162b2, or placebo. No serious adverse events have been reported. VLPCOV-01 induces robust immunoglobulin G (IgG) titers against the RBD protein that are maintained up to 26 weeks in non-elderly participants, with geometric means ranging from 5,037 (95% confidence interval [CI] 1,272–19,940) at 0.3 μg to 12,873 (95% CI 937–17,686) at 3 μg compared with 3,166 (95% CI 1,619–6,191) with 30 μg BNT162b2. Neutralizing antibody titers against all variants of SARS-CoV-2 tested are induced. VLPCOV-01 is immunogenic following low-dose administration. These findings support the potential for saRNA as a vaccine platform. Elsevier 2023-08-15 /pmc/articles/PMC10439244/ /pubmed/37586325 http://dx.doi.org/10.1016/j.xcrm.2023.101134 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article Akahata, Wataru Sekida, Takashi Nogimori, Takuto Ode, Hirotaka Tamura, Tomokazu Kono, Kaoru Kazami, Yoko Washizaki, Ayaka Masuta, Yuji Suzuki, Rigel Matsuda, Kenta Komori, Mai Morey, Amber L. Ishimoto, Keiko Nakata, Misako Hasunuma, Tomoko Fukuhara, Takasuke Iwatani, Yasumasa Yamamoto, Takuya Smith, Jonathan F. Sato, Nobuaki Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study |
title | Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study |
title_full | Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study |
title_fullStr | Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study |
title_full_unstemmed | Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study |
title_short | Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study |
title_sort | safety and immunogenicity of sars-cov-2 self-amplifying rna vaccine expressing an anchored rbd: a randomized, observer-blind phase 1 study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10439244/ https://www.ncbi.nlm.nih.gov/pubmed/37586325 http://dx.doi.org/10.1016/j.xcrm.2023.101134 |
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