tetano
Editor, Senior Moderator
Vaccine X
. 2023 Sep 18:15:100390.
doi: 10.1016/j.jvacx.2023.100390. eCollection 2023 Dec. Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan
Takuhiro Sonoyama[SUP] 1 [/SUP], Akari Kamitani[SUP] 1 [/SUP], Risa Y Shibata[SUP] 1 [/SUP], Naomi M Seki[SUP] 2 [/SUP], Shinya Omoto[SUP] 2 [/SUP], Kenji Igarashi[SUP] 1 [/SUP], Mari Ariyasu[SUP] 1 [/SUP]
Affiliations
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.
Keywords: Booster vaccine; COVID-19 vaccine; Cellular immunity; Clinical trial; Immunogenicity; Reactogenicity; Recombinant protein; Safety.
. 2023 Sep 18:15:100390.
doi: 10.1016/j.jvacx.2023.100390. eCollection 2023 Dec. Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan
Takuhiro Sonoyama[SUP] 1 [/SUP], Akari Kamitani[SUP] 1 [/SUP], Risa Y Shibata[SUP] 1 [/SUP], Naomi M Seki[SUP] 2 [/SUP], Shinya Omoto[SUP] 2 [/SUP], Kenji Igarashi[SUP] 1 [/SUP], Mari Ariyasu[SUP] 1 [/SUP]
Affiliations
- PMID: 37822891
- PMCID: PMC10562875
- DOI: 10.1016/j.jvacx.2023.100390
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.
Keywords: Booster vaccine; COVID-19 vaccine; Cellular immunity; Clinical trial; Immunogenicity; Reactogenicity; Recombinant protein; Safety.