Evidence map›Paper›PMID 35606235›Full record

Trial reportVaccine2022

Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings.

Satoshi Iwata, Takuhiro Sonoyama, Akari Kamitani, Risa Shibata, Tomoyuki Homma, Shinya Omoto, Kenji Igarashi, Mari Ariyasu

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.9field-weighted citation impact, top 13% 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

10 citing papers in PubMed, 19 citations in OpenAlex.

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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

8 authors at 2 institutions in 1 country.

Satoshi IwataNational Cancer Center Hospital, Department of Infectious Diseases, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
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 ShibataShionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
Tomoyuki HommaShionogi & Co., Ltd., Pharmaceutical Research Division, 1-1, Futaba-cho 3-chome, Toyonaka, Osaka 561-0825, Japan.
Shinya OmotoShionogi & Co., Ltd., Pharmaceutical 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. Electronic address: mari.tatsuno@shionogi.co.jp.
Futaba (Japan) · JPShionogi (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We initiated a randomized, placebo-controlled, phase 1/2 trial to evaluate the safety and immunogenicity of the S-268019-b recombinant protein vaccine, scheduled as 2 intramuscular injections given 21 days apart, in 60 randomized healthy Japanese adults. We evaluated 2 regimens of the S-910823 antigen (5 μg [n = 24] and 10 μg [n = 24]) with an oil-in-water emulsion formulation and compared against placebo (n = 12). Reactogenicity was mild in most participants. No serious adverse events were noted. For both regimens, vaccination resulted in robust IgG and neutralizing antibody production at days 36 and 50 and predominant T-helper 1-mediated immune reaction, as evident through antigen-specific polyfunctional CD4+ T-cell responses with IFN-γ, IL-2, and IL-4 production on spike protein peptides stimulation. Based on the interim analysis, the S-268019-b vaccine is safe, produces neutralizing antibodies titer comparable with that in convalescent serum from COVID-19-recovered patients. However, further evaluation of the vaccine in a large clinical trial is warranted.

Indexed as

COVID-19COVID-19 VaccinesAdultAntibodies, NeutralizingAntibodies, ViralCOVID-19 SerotherapyDouble-Blind MethodHumansImmunization, PassiveImmunogenicity, VaccineJapanSARS-CoV-2Vaccines, SyntheticAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesVaccines, SyntheticCellular immunityClinical trialCOVID-19 vaccineImmunogenicityReactogenicityRecombinant proteinSafety

Identifiers

PMID35606235
PMCPMC9122779
OpenAlexW4280615609

What OpenQuestion holds

Textmetadata
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.