Evidence map›Paper›PMID 41519137›Full record

Trial reportThe Lancet. Infectious diseases2026

Safety and immunogenicity of PanChol, a single-dose live-attenuated oral cholera vaccine: results from a phase 1a, double-blind, randomised, placebo-controlled trial.

Deborah R Leitner, Stephen R Walsh, Masataka Suzuki, Michaël Desjardins, Alisse Hannaford, Amy C Sherman, Hannah Levine, Lena Carr, Elliot Hammerness, Akina Osaki and 13 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Applied and environmental microbiology · 2026
    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

23 authors.

Deborah R LeitnerDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA.
Stephen R WalshDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.
Masataka SuzukiDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA.
Michaël DesjardinsDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Alisse HannafordDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.
Amy C ShermanDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.
Hannah LevineDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA.
Lena CarrDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA.
Elliot HammernessDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA.
Akina OsakiDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA.
Emily SullivanDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA.
Bryan WangDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA.
George I BalazsDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA.
Jun Bai Park ChangDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA.
Damien M SlaterDivision of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Department of Pediatrics, Harvard Medical School, Boston, MA, USA.
Nirajan PuriCenter for Clinical Investigation, Brigham and Women's Hospital, Boston, MA, USA.
Carole J KuehlDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA.
Wilbur H ChenCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MA, USA.
Jason B HarrisDivision of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Department of Pediatrics, Harvard Medical School, Boston, MA, USA.
Steven PiantadosiDepartment of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Lindsey R BadenDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA. Electronic address: lbaden@bwh.harvard.edu.
Matthew K WaldorDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA; Department of Microbiology, Harvard Medical School, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA; Howard Hughes Medical Institute, Boston, MA, USA. Electronic address: mwaldor@bwh.harvard.edu.
PanChol study group

Funding

Vibrio cholerae intestinal colonization and vaccine developmentR01AI042347 · NIAID · TUFTS UNIVERSITY BOSTON · PI WALDOR, MATTHEW K · 1998 to 2025
$7.3M
Defining vaccine immunogenicity and adoptive transfer in hematopoietic stem cell transplant recipientsK23AI185318 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Amy Caryn Sherman · 2025 to 2026
$389k
NIAID NIH HHS K23 AI185318NIAID NIH HHS R01 AI042347
6 · The paper itself

Abstract

backgroundKilled whole-cell oral cholera vaccines can be used to prevent cholera but require multiple doses and have limited efficacy in young children. PanChol is a single-dose, live-attenuated, oral cholera vaccine derived from a current seventh pandemic Vibrio cholerae O1 strain. It co-expresses Inaba and Ogawa antigens, over-expresses the non-toxic cholera toxin B subunit, and is designed to minimise reactogenicity and be incapable of toxigenic reversion. We aimed to assess safety and immunogenicity of PanChol in a first-in-human trial.

methodsThis phase 1a trial was conducted at the Brigham and Women's Hospital (Boston, MA, USA) and involved an open-label fixed dose-escalation module, followed by a randomised, double-blind, placebo-controlled dose-expansion module. Eligible participants were healthy adults aged 18-55 years without a previous V cholerae infection or cholera vaccination or a history of gastrointestinal disorders. In the open-label dose-escalation phase, eligible participants were enrolled into one of five cohorts receiving one dose of oral 10

findingsBetween Dec 13, 2022, and Feb 7, 2025, 57 healthy adults were enrolled, including 15 in the dose-escalation module (three in each group), six in the dose de-escalation module (three in each group), and 36 in the dose-expansion module (14 assigned to 10

interpretationA single oral dose of PanChol was safe and well tolerated at all doses and induced 100% vibriocidal seroconversion over a 100 000-fold dose range. These findings support the progression of PanChol into later phase clinical trials, including studies in endemic settings and in children.

fundingWellcome Trust.

Indexed as

CholeraCholera VaccinesImmunogenicity, VaccineVibrio cholerae O1Administration, OralAdolescentAdultAntibodies, BacterialDouble-Blind MethodFemaleHumansMaleMiddle AgedVaccines, AttenuatedYoung AdultAntibodies, BacterialCholera VaccinesVaccines, Attenuated

Identifiers

PMID41519137
PMCPMC13103297

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Registered trials

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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.