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June 20, 2022VaccineOpen Access

Immunogenicity 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 study

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Key result

S-268019-b booster yields noninferior day 29 neutralizing antibody titers compared to BNT162b2.

  • adjusted-GMT ratio 1.14
  • 95% CI 0.94-1.39
  • P<0.0001 for noninferiority
  • n=204

Why the study?

Does S-268019-b booster elicit noninferior neutralizing antibody responses compared to BNT162b2 in Japanese adults previously vaccinated with BNT162b2?

Population

Japanese adults without prior SARS-CoV-2 infection vaccinated with 2-dose BNT162b2 ≥6 months prior

Comparison

S-268019-b booster vs BNT162b2 booster

Design

Phase 2/3 randomized, observer-blinded, noninferiority study

Follow-up

Day 29

Authors

MSMasaharu ShinkaiTSTakuhiro SonoyamaAKAkari Kamitani

Discussion

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Member takes

Overview

Supports S-268019-b as a COVID-19 booster alternative; confirms noninferior neutralizing antibody responses to BNT162b2 in RCT.

Study Design

Type

RCT (n=204)

Blinding

observer-blinded

Randomization

randomized

Structured PICO

Does S-268019-b booster elicit noninferior neutralizing antibody responses compared to BNT162b2 in Japanese adults previously vaccinated with BNT162b2?

P
Population
204 Japanese adults without prior SARS-CoV-2 infection, evaluated for immunogenicity of a booster dose ≥6 months after a 2-dose BNT162b2 regimen.
I
Intervention
S-268019-b (recombinant spike protein vaccine) as a booster dose
C
Comparator
BNT162b2 as a booster dose
O
Outcome
Neutralizing antibodies on day 29 (geometric mean titer and seroresponse rate)surrogate

Main Result

Effect estimate: adjusted-GMT ratio 1.14 (95% CI 0.94-1.39)

Absolute Event Rate: 124.97% vs 109.7%

p-value: p=<0.0001 for noninferiority

S-268019-b is safe and highly immunogenic as a booster dose, demonstrating noninferiority to BNT162b2 in neutralizing antibody responses.

Cite This Study

Shinkai et al. (2022) conducted an RCT in COVID-19 (n=204). S-268019-b vs. BNT162b2 was evaluated on neutralizing antibodies on day 29 (geometric mean titer) (adjusted-GMT ratio 1.14, 95% CI 0.94-1.39, p=<0.0001 for noninferiority). S-268019-b was noninferior to BNT162b2 as a COVID-19 booster for day 29 neutralizing antibody geometric mean titer (adjusted-GMT ratio 1.14; 95% CI 0.94-1.39; P<0.0001 for noninferiority).

synapsesocial.com/papers/6aa93fc511a60bccbd2645d1https://doi.org/10.1016/j.vaccine.2022.06.032
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Also Consider

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

  1. 1Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan2023 · 5 citations
  2. 2Immunogenicity and safety of a SARS-CoV-2 recombinant vaccine S-268024 booster vaccination versus NVX-CoV2373: Interim results from a phase 3, multicenter, randomized, observer-blind, active-controlled study2026 · 1 citations
  3. 3A phase 3 randomized controlled trial of a COVID-19 recombinant vaccine S-268019-b versus ChAdOx1 nCoV-19 in Japanese adults2024 · 6 citations
  4. 4Longitudinal analysis of B- and T-cell responses to SARS-CoV-2 recombinant S-protein vaccine S-268019-b in phase 1/2 priming and booster study2024 · 1 citations
  5. 5A SARS-CoV-2 recombinant spike protein vaccine (S-268019-b) for COVID-19 prevention during the Omicron-dominant period: A phase 3, randomised, placebo-controlled clinical trial2024 · 3 citations