Evidence map›Paper›PMID 36732164›Full record

Trial reportVaccine2023

Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan.

Yumi Tsuchiya, Hiroshi Tamura, Koji Fujii, Hirotaka Numaguchi, Kiichiro Toyoizumi, Tina Liu, Mathieu Le Gars, Vicky Cárdenas, Takashi Eto

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase I
In one paragraph

Trial report in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04509947 (A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 19% 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.

NCT04509947 phase1completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults

TypeinterventionalSponsorJanssen Pharmaceutical K.K.Ran2020 to 2021Enrolled250ConditionsHealthyArmsAd26.COV2.S, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. 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

9 authors at 5 institutions in 5 countries.

Yumi TsuchiyaResearch and Development, Janssen Pharmaceutical K.K., Tokyo, Japan. Electronic address: ytsuchi3@its.jnj.com.
Hiroshi TamuraResearch and Development, Janssen Pharmaceutical K.K., Tokyo, Japan.
Koji FujiiResearch and Development, Janssen Pharmaceutical K.K., Tokyo, Japan.
Hirotaka NumaguchiResearch and Development, Janssen Pharmaceutical K.K., Tokyo, Japan.
Kiichiro ToyoizumiStatistics and Decision Sciences, Janssen Pharmaceutical K.K., Tokyo, Japan.
Tina LiuClinical and Statistical Programming, Janssen China Research and Development, Beijing, China.
Mathieu Le GarsJanssen Vaccines and Prevention, Leiden, the Netherlands.
Vicky CárdenasJanssen Research and Development, Spring House, USA.
Takashi EtoSouseikai Hakata Clinic, Fukuoka-city, Fukuoka, Japan.
Development Research Center · CNJanssen (Belgium) · BEJanssen (Netherlands) · NLJanssen (United States) · USSOUSEIKAI Global Clinical Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated safety, reactogenicity, and immunogenicity of a 2-month homologous booster regimen of Ad26.COV2.S in Japanese adults.

methodsIn this multicenter, placebo-controlled, Phase 1 trial, adults (Cohort 1, aged 20-55 years, N = 125; Cohort 2, aged ≥ 65 years, N = 125) were randomized 2:2:1 to receive Ad26.COV2.S 5 × 10

resultsTwo hundred participants received Ad26.COV2.S and 50 received placebo. The most frequent solicited local adverse event (AE) was vaccination-site pain, and the most frequent solicited systemic AEs were fatigue, myalgia, and headache. After primary vaccination, neutralizing and binding antibody levels increased through Day 57 (post-prime) in both cohorts. Fourteen days after boosting (Day 71), neutralizing antibody geometric mean titers (GMTs) had almost reached their peak value in Cohort 1 (5 × 10

conclusionA single dose and homologous Ad26.COV2.S booster increased antibody responses with an acceptable safety profile in Japanese adults (ClinicalTrials.gov Identifier: NCT04509947).

Indexed as

COVID-19COVID-19 VaccinesAd26COVS1AdultAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodHumansImmunogenicity, VaccineJapanAd26COVS1Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesAd26.COV2.SCOVID-19Phase 1 clinical trialSARS-CoV-2VaccineVirus neutralization assay

Identifiers

PMID36732164
PMCPMC9812825
OpenAlexW4313550246

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.