Evidence map›Paper›PMID 42379208›Full record

ArticleThe Lancet. Infectious diseases2026

Efficacy of WRSs2, a live-attenuated Shigella sonnei vaccine, against shigellosis in a controlled human infection model in the USA: a phase 2, double-blind, randomised, placebo-controlled trial.

Nadine Rouphael, Shahida Baqar, Michelle Dickey, Christina Quigley, Tena Pham, Josh Adams, Gaurav Kwatra, Sarah Bechnak, Veronica Smith, Erin M Scherer and 13 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet. Infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

23 authors.

Nadine RouphaelHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University, Decatur, GA, USA. Electronic address: nroupha@emory.edu.
Shahida BaqarDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, US National Institutes of Health, Bethesda, MD, USA.
Michelle DickeyDivision of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Christina QuigleyDivision of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Tena PhamDivision of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Josh AdamsDivision of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Gaurav KwatraDivision of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Sarah BechnakHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University, Decatur, GA, USA.
Veronica SmithHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University, Decatur, GA, USA.
Erin M SchererHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University, Decatur, GA, USA.
Daniel S GraciaaHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University, Decatur, GA, USA.
Jill El-KhorazatyThe Emmes Company, Rockville, MD, USA.
Jamie A FraserThe Emmes Company, Rockville, MD, USA.
Susan HeardThe Emmes Company, Rockville, MD, USA.
Krista CatoDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, US National Institutes of Health, Bethesda, MD, USA.
Jorge Mejia-GalvisDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, US National Institutes of Health, Bethesda, MD, USA.
Shoshana BarnoyWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Lakshmi ChandrasekharanWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Chad K PorterNaval Medical Research Command, Silver Spring, MD, USA.
Akamol E SuvarnapunyaWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Malabi M VenkatesanWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Robert W FrenckDivision of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
DMID 17-0112 Study Group

Funding

Statistical Data Coordinating Center: Monkeypox Clinical Research Support75N93021C00012 · NIAID · THE EMMES COMPANY, LLC · PI EWELL, MARIAN · 2021 to 2025
$150.3M
NIAID NIH HHS HHSN272200800006CNIAID NIH HHS HHSN272200800013CNIAID NIH HHS HHSN272201300016CNIAID NIH HHS HHSN272201300016INIAID NIH HHS HHSN272201300018INIH HHS 75N93021C00012
6 · The paper itself

Abstract

backgroundDespite long-standing research, no licensed vaccine exists for shigella, a leading cause of bacterial diarrhoea and dysentery. WRSs2 is a live-attenuated Shigella sonnei vaccine candidate which has previously shown safety and immunogenicity. In this trial, we evaluated its safety and efficacy in a controlled human infection model.

methodsIn this phase 2, double-blind, randomised, placebo-controlled trial at two sites in the USA, healthy adults aged 18-49 years were assigned using a site-stratified permuted-block schedule. The original three-arm design allocated participants 1:1:1 to two-dose WRSs2 (10

findingsBetween Oct 11, 2022, and Jan 9, 2024, 108 participants were enrolled, with 22 assigned to two-dose 10

interpretationIn adults in the USA, WRSs2 provided high-level protection against S sonnei shigellosis. Although protection was substantial, the occurrence of a few self-limiting grade 3 adverse events indicates that further optimisation is needed to better define the safety-efficacy balance. These findings support further clinical development of live-attenuated shigella vaccines.

fundingUS National Institutes of Health with pharmaceutical support from the US Department of Defense.

Identifiers

PMID42379208
PMCPMC13435326

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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.