Evidence map›Paper›PMID 40818478›Full record

Trial reportThe Lancet. Infectious diseases2025

Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial.

Laina D Mercer, Arlene C Seña, E Ross Colgate, Jessica W Crothers, Peter F Wright, Mohamed Al-Ibrahim, Erman Tritama, Annelet Vincent, Bernardo A Mainou, Yiting Zhang and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04529538 (A First-in-human, Phase 1, Randomized, Observer-blind, Controlled Study to Assess the Safety and Immunogenicity of Novel Live Attenuated Type 1 and Type 3 Oral Poliomyelitis Vaccines in Healthy Adults), which is not on this 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.

NCT04529538 phase1completednot on this map

A First-in-human, Phase 1, Randomized, Observer-blind, Controlled Study to Assess the Safety and Immunogenicity of Novel Live Attenuated Type 1 and Type 3 Oral Poliomyelitis Vaccines in Healthy Adults

TypeinterventionalSponsorPATHRan2021 to 2023Enrolled226ConditionsPoliomyelitisArmsNovel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 3 (nOPV3), Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1), Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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.

Laina D MercerCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USA.
Arlene C SeñaUniversity of North Carolina at Chapel Hill, Institute for Global Health and Infectious Diseases, Chapel Hill, NC, USA.
E Ross ColgateThe Vaccine Testing Center, Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT, USA.
Jessica W CrothersThe Vaccine Testing Center, Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT, USA; Department of Pathology and Laboratory Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA.
Peter F WrightGeisel School of Medicine, Dartmouth, Hanover, NH, USA.
Mohamed Al-IbrahimPharmaron CPC, Baltimore, MD, USA.
Erman TritamaPT Bio Farma, Bandung, Indonesia.
Annelet VincentPolio and Picornavirus Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Bernardo A MainouPolio and Picornavirus Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Yiting ZhangPolio and Picornavirus Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jennifer Konopka-AnstadtCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USA.
Ananda S BandyopadhyayBill & Melinda Gates Foundation, Seattle, WA, USA.
Alan FixCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USA.
John O KonzCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USA.
Chris GastCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USA. Electronic address: cgast@path.org.

Funding

Understanding the Development of Mucosal Immunity to Poliovirus: Adjuvants and Modulation of the Enteric MicrobiotaK23AI175660 · NIAID · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI Jessica W. Crothers · 2024 to 2026
$485k
Gates Foundation INV-007007NIAID NIH HHS K23 AI175660
6 · The paper itself

Abstract

backgroundReducing the risks of vaccine-derived polioviruses and vaccine-associated paralytic poliomyelitis motivated the development of novel types 1 and 3 oral poliovirus vaccines (nOPV1 and nOPV3, respectively), designed to have similar safety and immunogenicity and improved genetic stability (to reduce risk of reversion to neurovirulence) relative to types 1 or 3 Sabin-strain OPVs. We aimed to assess the safety and immunogenicity of nOPV1 and nOPV3 in healthy adults.

methodsWe did a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial in healthy adults at four centres in the USA. Participants were block randomised, stratified by site and according to polio vaccination history (inactivated poliovirus vaccine [IPV] only [hereafter IPV participants] or regimens including OPV [hereafter OPV participants]), and randomly assigned to receive either nOPV or homotypic Sabin-strain monovalent OPV (mOPV). IPV participants received a single dose of nOPV1 or mOPV1 (cohort 1) or nOPV3 or mOPV3 (cohort 3) and OPV participants received two doses 28 days apart of nOPV1 or mOPV1 (cohort 2) or nOPV3 or mOPV3 (cohort 4). The primary outcome was safety among vaccinated participants. Secondary outcomes included homotypic serum neutralising antibody responses measured before and 28 days after each dose in a per-protocol population, and faecal viral shedding mainly in IPV participants assessed up to 56 days following each dose among vaccinated participants. This study was registered with ClinicalTrials.gov (NCT04529538) and is complete.

findingsBetween May 6, 2021 and Feb 17, 2023, 377 individuals were assessed for eligibility, 226 were randomly assigned, and 205 receive at least one dose of nOPV1 (n=70), mOPV1 (n=45), nOPV3 (n=54), or mOPV3 (n=36). No serious adverse events were observed. Most adverse events were mild, severe events were rare, and solicited events were balanced across groups. Severe solicited events were predominantly fatigue, occurring in 1-4% of participants across all groups except for mOPV1 recipients in whom no such events were reported, and one case of nausea and vomiting in an mOPV1 recipient, and one case of abdominal pain in an nOPV1 recipient. Two (3%) participants in the nOPV1 groups (one reporting severe fatigue, headache, and myalgia, and one reporting abdominal pain) and one (2%) participant in the mOPV1 groups (kidney infection) reported a severe unsolicited adverse event within 28 days. Homotypic seroprotection was nearly 100% at baseline and was 100% 28 days after the first dose. Homotypic seroconversion rates after a single dose were high and similar for nOPV and mOPV (ranging from 86% to 100% for nOPV and from 86% to 93% for mOPV). Similar rates of viral shedding were observed among participants receiving nOPV or mOPV. Peak viral shedding rate detected via PCR among IPV participants was 100% on day 8 after a dose, across groups.

interpretationnOPV1 and nOPV3 were well tolerated and showed similar immunogenicity and shedding profiles to mOPV1 and mOPV3, respectively, supporting progression of these vaccine candidates to phase 2 studies.

fundingBill & Melinda Gates Foundation.

Indexed as

Immunogenicity, VaccinePoliomyelitisPoliovirusPoliovirus Vaccine, OralAdolescentAdultAntibodies, NeutralizingAntibodies, ViralFemaleHealthy VolunteersHumansMaleMiddle AgedUnited StatesVaccinationVaccines, AttenuatedAntibodies, NeutralizingAntibodies, ViralPoliovirus Vaccine, OralVaccines, Attenuated

Identifiers

PMID40818478
PMCPMC12630075

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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.