Evidence map›Paper›PMID 37822891›Full record

ArticleVaccine: X2023

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, Akari Kamitani, Risa Y Shibata, Naomi M Seki, Shinya Omoto, Kenji Igarashi, Mari Ariyasu

Open access · goldAbstract read
In one paragraph

Article in Vaccine: X, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Takuhiro SonoyamaShionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
Akari KamitaniShionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
Risa Y ShibataShionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
Naomi M SekiShionogi & Co., Ltd., Biopharmaceutical Research Division, 1-1, Futaba-cho 3-chome, Toyonaka, Osaka 561-0825, Japan.
Shinya OmotoShionogi & Co., Ltd., Biopharmaceutical Research Division, 1-1, Futaba-cho 3-chome, Toyonaka, Osaka 561-0825, Japan.
Kenji IgarashiShionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
Mari AriyasuShionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
Shionogi (Japan) · JPFutaba (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Booster vaccineCellular immunityClinical trialCOVID-19 vaccineImmunogenicityReactogenicityRecombinant proteinSafety

Identifiers

PMID37822891
PMCPMC10562875
OpenAlexW4386827121

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.