Evidence map›Paper›PMID 40318674›Full record

SynthesisThe Lancet. Microbe2025

Intestinal mucosal immune responses induced by novel oral poliovirus vaccine type 2 and Sabin monovalent oral poliovirus vaccine type 2: an analysis of data from four clinical trials.

Audrey Godin, Elizabeth B Brickley, Ruth I Connor, Wendy F Wieland-Alter, Margaret E Ackerman, Joshua A Weiner, John Modlin, Minetaro Arita, Ananda S Bandyopadhyay, Chris Gast and 5 more

3 registry-linked trialsAbstract readComparative StudyMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in The Lancet. Microbe, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02521974 phase4completednot on this map

A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy Children Aged 1 to 5 Years and in bOPV-IPV Vaccinated Healthy Infants

TypeinterventionalSponsorFidec CorporationRan2015 to 2016Enrolled164ConditionsAdverse Event Following ImmunisationArmsSABIN monovalent OPV2
NCT03554798 phase2completednot on this map

A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Novel Oral Polio Type 2 (nOPV2) Vaccine Candidates in Healthy Children Aged 1 to 5 Years and in Healthy Bivalent Oral Polio Vaccine-inactivated Polio Vaccine (bOPV-IPV) Vaccinated Infants

TypeinterventionalSponsorFidec CorporationRan2018 to 2020Enrolled1,025ConditionsPoliomyelitisArmsnOPV2 (monovalent oral polio vaccine)
NCT04544787 phase2completednot on this map

A Phase 2, Partial Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of Two Novel Live Attenuated Serotype 2 Oral Poliovirus Vaccines Candidates, in Healthy Adults Previously Vaccinated With Oral Polio Vaccine (OPV) or Inactivated Polio Vaccine (IPV), Compared With Historical Controls Given Sabin OPV2 or Placebo

TypeinterventionalSponsorPierre Van DammeRan2018 to 2019Enrolled250ConditionsPoliomyelitisArmsNovel OPV2 candidate 1, Novel OPV2 candidate 2, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Intestinal Mucosal Immune Responses to Novel Oral Poliovirus Vaccine Type 2 in Healthy Newborns.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 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

15 authors.

Audrey GodinHealth Equity Action Lab, Department of Infectious Disease Epidemiology and International Health, London School of Hygiene & Tropical Medicine, London, UK.
Elizabeth B BrickleyHealth Equity Action Lab, Department of Infectious Disease Epidemiology and International Health, London School of Hygiene & Tropical Medicine, London, UK.
Ruth I ConnorDepartment of Pediatrics, Geisel School of Medicine at Dartmouth, Dartmouth Health, Lebanon, NH, USA.
Wendy F Wieland-AlterDepartment of Pediatrics, Geisel School of Medicine at Dartmouth, Dartmouth Health, Lebanon, NH, USA.
Margaret E AckermanThayer School of Engineering, Dartmouth College, Hanover, NH, USA.
Joshua A WeinerThayer School of Engineering, Dartmouth College, Hanover, NH, USA.
John ModlinDepartment of Pediatrics, Geisel School of Medicine at Dartmouth, Dartmouth Health, Lebanon, NH, USA.
Minetaro AritaDepartment of Virology II, National Institute of Infectious Diseases, Tokyo, Japan.
Ananda S BandyopadhyayBill & Melinda Gates Foundation, Seattle, WA, USA.
Chris GastPATH Center for Vaccine Innovation and Access, Seattle, WA, USA.
Xavier Sáez-LlorensInfectious Disease Department, Hospital del Niño Dr José Renán Esquivel, Senacyt and Cevaxin Research Centers, Panama City, Panama.
Ricardo W RüttimannFighting Infectious Diseases in Emerging Countries, Miami, FL, USA.
Pierre Van DammeCentre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
Ilse De CosterCentre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
Peter F WrightDepartment of Pediatrics, Geisel School of Medicine at Dartmouth, Dartmouth Health, Lebanon, NH, USA. Electronic address: peter.f.wright@hitchcock.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA novel oral polio vaccine type 2 (nOPV2), which is more genetically stable (ie, lower risks of reverting to neurovirulence) than the Sabin monovalent OPV2 (mOPV2), has been deployed to interrupt circulating vaccine-derived poliovirus type 2 (PV2) outbreaks. This study compares intestinal mucosal immune responses induced by nOPV2 and mOPV2.

methodsIn this analysis, we evaluated intestinal mucosal immune responses in healthy participants of different ages (ie, infants aged 18-22 weeks, children aged 1-4 years, and adults aged 18-50 years) and vaccine backgrounds (ie, OPV2-experienced vs OPV2-naive). Participants were selected from two phase 2 trials of nOPV2, conducted in 2018-19 (infants and children, NCT03554798 [Panama]; adults, EudraCT 2018-001684-22-NCT04544787 [Belgium]), and two phase 4 historical control trials of mOPV2, conducted in 2015-16 (infants and children, NCT02521974 [Panama]; adults, EudraCT 2015-003325-33 [Belgium]). We measured PV2-specific neutralising activity and IgA concentrations in stools collected before and 14 days after vaccination.

findingsWe compared data from 160 participants (ie, 47 infants, 47 children, and 66 adults) in the nOPV2 trials to 188 participants (ie, 42 infants, 46 children, and 100 adults) in the mOPV2 trials. Within each age group, one dose of nOPV2 or mOPV2 induced similar intestinal PV2-specific neutralisation and IgA responses on day 14. Responses diminished with age: among the OPV2-naive participants who received nOPV2, 27 (82%) of 33 infants, 17 (61%) of 28 children, and four (25%) of 16 adults had detectable PV2-specific neutralisation on day 14. Despite having similar median log

interpretationWe found no evidence of differences in the intestinal mucosal immune responses induced by nOPV2 or Sabin mOPV2 and observed the strongest responses in infants.

fundingThe Bill & Melinda Gates Foundation, Japan Agency for Medical Research and Development.

Indexed as

Immunity, MucosalIntestinal MucosaPoliomyelitisPoliovirusPoliovirus Vaccine, OralAdolescentAdultAntibodies, NeutralizingAntibodies, ViralChild, PreschoolClinical Trials, Phase II as TopicClinical Trials, Phase IV as TopicFemaleHumansImmunoglobulin AInfantAntibodies, NeutralizingAntibodies, ViralImmunoglobulin APoliovirus Vaccine, Oral

Identifiers

PMID40318674
PMCPMC12134050

What OpenQuestion holds

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LicenceCC BY
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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.