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September 18, 2023Vaccine XOpen Access

Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan

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Key result

A booster dose of S-268019-b was safe and enhanced SARS-CoV-2 neutralizing antibodies, IgG antibodies, and T-helper 1-mediated immune reactions in Japanese adults with prior mRNA vaccination.

Why the study?

Booster vaccination has become increasingly important against SARS-CoV-2 variants with immune-escaping capacity despite the initial success of primary vaccines.

Does S-268019-b booster improve immunogenicity and maintain safety in Japanese adults previously vaccinated with mRNA vaccines?

Population

Japanese adults (aged 20-64 years) and elderly (aged ≥ 65 years) primed with mRNA vaccines

Comparison

S-268019-b booster dose

Design

Phase 3 open-label clinical study

Follow-up

Day 29

Authors

TSTakuhiro SonoyamaAKAkari KamitaniRSR. Shibata

Discussion

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Member takes

Overview

Supports S-268019-b booster immunogenicity in mRNA recipients; leaves open randomized confirmation before practice change.

Structured PICO

Does S-268019-b booster improve immunogenicity and maintain safety in Japanese adults previously vaccinated with mRNA vaccines?

P
Population
Japanese adults and elderly who had completed primary vaccination with mRNA-1273 or BNT162b2, followed until Day 29 after a booster dose.
I
Intervention
S-268019-b (SARS-CoV-2 spike protein and a squalene-based adjuvant) as a booster dose
O
Outcome
Safety and immunogenicity (SARS-CoV-2 neutralizing antibodies, immunoglobulin G antibodies, and T-helper 1-mediated immune reaction) until Day 29safety

S-268019-b as a booster dose is safe and immunogenic in Japanese adults previously vaccinated with mRNA vaccines.

Cite This Study

Sonoyama et al. (2023) studied SARS-CoV-2. S-268019-b was evaluated on Safety and immunogenicity (neutralizing antibodies, immunoglobulin G antibodies, and T-helper 1-mediated immune reaction). A booster dose of S-268019-b was safe and enhanced SARS-CoV-2 neutralizing antibodies, IgG antibodies, and T-helper 1-mediated immune reactions in Japanese adults with prior mRNA vaccination.

synapsesocial.com/papers/6a9db55d2e7adb891e48b508https://doi.org/10.1016/j.jvacx.2023.100390
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Immunogenicity and safety of booster dose of S-268019-b or BNT162b2 in Japanese participants: An interim report of phase 2/3, randomized, observer-blinded, noninferiority study2022 · 21 citations
  2. 2Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b22021 · 829 citations
  3. 3Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial2021 · 699 citations
  4. 4The Vaccine Efficacy Against the SARS-CoV-2 Omicron: A Systemic Review and Meta-Analysis2022 · 57 citations
  5. 5Vaccine-Associated Enhanced Disease and Pathogenic Human Coronaviruses2022 · 75 citations