Evidence map›Paper›PMID 41746067›Full record

ArticleVaccines2026

Immunogenicity and Safety of the ExPEC9V

Isabel Leroux-Roels, Tracey A Day, Sofie Deleu, Chelsea McLean, Oscar Go, Todd A Davies, Jeroen N Stoop, Monika Peeters, Maria G Pau, Bart Spiessens and 3 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06134804 (A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older), 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
–field-weighted citation impact
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.

NCT06134804 phase3completednot on this map

A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

TypeinterventionalSponsorJanssen Research & Development, LLCRan2023 to 2024Enrolled959ConditionsInvasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) PreventionArmsExPEC9V, Placebo, HD quadrivalent influenza vaccine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Research Progress on perinatalFrontiers in microbiology · 2026
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Isabel Leroux-RoelsCenter for Vaccinology, Ghent University and Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium.ORCID 0000-0002-5084-4696
Tracey A DayJohnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium.
Sofie DeleuJohnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium.
Chelsea McLeanJohnson & Johnson, Archimedesweg 4, 2333CN Leiden, The Netherlands.ORCID 0000-0002-3548-3482
Oscar GoJohnson & Johnson, 920 US-202, Raritan, NJ 08869, USA.
Todd A DaviesJohnson & Johnson, 920 US-202, Raritan, NJ 08869, USA.
Jeroen N StoopJohnson & Johnson, Archimedesweg 4, 2333CN Leiden, The Netherlands.
Monika PeetersJohnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium.
Maria G PauJohnson & Johnson, Archimedesweg 4, 2333CN Leiden, The Netherlands.
Bart SpiessensJohnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium.
Michal SarneckiJohnson & Johnson, Rehhagstrasse 79, 3018 Bern, Switzerland.ORCID 0000-0001-7035-0020
Keira A CohenJohnson & Johnson, 1125 Bear Tavern Rd, New Brunswick, NJ 08560, USA.ORCID 0000-0002-4521-397X
E.ngage Study Team

Funding

Johnson & Johnson Not applicableSanofi Not applicable
6 · The paper itself

Abstract

backgroundExPEC9V is a 9-valent vaccine candidate designed to prevent invasive

methodsThis Phase 3, double-blind, placebo-controlled study (NCT06134804) randomized 959 adults (≥65 years) to receive co-administration of ExPEC9V and HD quadrivalent seasonal influenza vaccine (CoAd) or each vaccine alone, 29 days apart (Control). Co-primary objectives were non-inferiority of co-administration versus separate administration following predefined criteria based on influenza strain-specific hemagglutination inhibition (HAI) antibody titers and ExPEC9V O-serotype binding antibody levels (multiplex electrochemiluminescence-based immunoassay), 29 days post vaccination. Reactogenicity and safety were assessed.

resultsCo-administration of ExPEC9V with HD influenza vaccine demonstrated non-inferiority (upper bound of 2-sided 95% confidence interval [CI] < 1.5 for HAI geometric mean ratio [Control/CoAd]) for all influenza strains. Non-inferiority for ExPEC9V O-serotype antibody levels was not demonstrated (upper bound 95% CI > 1.5). One of nine serotypes met the non-inferiority criterion; eight did not, with four narrowly failing to meet the non-inferiority criterion. ExPEC9V immunogenicity was similar regardless of urinary tract infection history. ExPEC9V was safe and well tolerated, with no serious adverse events related to ExPEC9V. Reactogenicity rate was higher with co-administration.

conclusionsCo-administration of ExPEC9V with HD influenza vaccine met non-inferiority criteria of humoral immune responses for influenza antigens, but not for ExPEC9V O-serotype antigens. ExPEC9V, administered alone or with HD influenza vaccine, was safe and well tolerated, with an acceptable reactogenicity profile.

Indexed as

clinical trialEscherichia coliExPEC9Vhigh-dose influenza vaccineinvasive E. coli diseaseO-serotypesvaccinevaccine co-administration

Identifiers

PMID41746067
PMCPMC12944986

What OpenQuestion holds

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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.