Evidence map›Paper›PMID 36746739›Full record

Trial reportVaccine2023

Safety, tolerability, and immunogenicity of inactivated poliovirus vaccine with or without E.coli double mutant heat-labile toxin (dmLT) adjuvant in healthy adults; a phase 1 randomized study.

Rahsan Erdem, Ilse De Coster, Kanchanamala Withanage, Laina D Mercer, Arnaud Marchant, Martin Taton, Nathalie Cools, Eva Lion, Fred Cassels, Deborah Higgins and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04232943 (A Phase 1 Randomized Study to Examine the Safety, Tolerability, and Immunogenicity of Inactivated Poliovirus Vaccine), 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
1.1field-weighted citation impact, top 22% of its field
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.

NCT04232943 phase1completednot on this map

A Phase 1 Randomized Study to Examine the Safety, Tolerability, and Immunogenicity of Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat Labile Toxin (dmLT) and Impact on Poliovirus Shedding Post-bOPV Challenge in Healthy IPV-Primed Adult Subjects

TypeinterventionalSponsorPATHRan2020 to 2021Enrolled87ConditionsPolioArmsInactivated Poliomyelitis Vaccine (IPV), E.coli Double Mutant Heat-Labile Toxin (dmLT) (adjuvant), Bivalent Oral Polio Vaccine (bOPV)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Recent advances in enterotoxin vaccine adjuvants.Current opinion in immunology · 2023
    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

20 authors at 5 institutions in 2 countries.

Rahsan ErdemPATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Ilse De CosterVaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, University of Antwerp, Edegem, Belgium. Electronic address: ilse.decoster@uantwerpen.be.
Kanchanamala WithanageVaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, University of Antwerp, Edegem, Belgium.
Laina D MercerPATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Arnaud MarchantInstitute for Medical Immunology, Université libre de Bruxelles, Brussels, Belgium.
Martin TatonInstitute for Medical Immunology, Université libre de Bruxelles, Brussels, Belgium.
Nathalie CoolsVaccine & Infectious Disease Institute, Laboratory of Experimental Hematology, University of Antwerp, Wilrijk, Belgium.
Eva LionVaccine & Infectious Disease Institute, Laboratory of Experimental Hematology, University of Antwerp, Wilrijk, Belgium.
Fred CasselsPATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Deborah HigginsPATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Karen IvinsonPATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Emily LockePATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Kutub MahmoodPATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Peter F WrightDartmouth College, Lebanon, NH, USA.
Chris GastPATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Jessica A WhitePATH, Center for Vaccine Innovation and Access, Seattle, WA, USA.
Margaret E AckermanDartmouth College, Lebanon, NH, USA.
Jennifer L Konopka-AnstadtDivision of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Bernardo A MainouDivision of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Pierre Van DammeVaccine & Infectious Disease Institute, Centre for the Evaluation of Vaccination, University of Antwerp, Edegem, Belgium.
Program for Appropriate Technology in Health · USUniversity of Antwerp · BECenters for Disease Control and Prevention · USDartmouth College · USUniversité Libre de Bruxelles · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInactivated trivalent poliovirus vaccine (IPV) induces humoral immunity, which protects against paralytic poliomyelitis but does not induce sufficient mucosal immunity to block intestinal infection. We assessed the intestinal immunity in healthy adults in Belgium conferred by a co-formulation of IPV with the mucosal adjuvant double mutant Labile Toxin (dmLT) derived from Escherichia coli.

methodsHealthy fully IPV-vaccinated 18-45-year-olds were randomly allocated to three groups: on Day 1 two groups received one full dose of IPV (n = 30) or IPV + dmLT (n = 30) in a blinded manner, and the third received an open-label dose of bivalent live oral polio vaccine (bOPV types 1 and 3, n = 20). All groups received a challenge dose of bOPV on Day 29. Participants reported solicited and unsolicited adverse events (AE) using study diaries. Mucosal immune responses were measured by fecal neutralization and IgA on Days 29 and 43, with fecal shedding of challenge viruses measured for 28 days. Humoral responses were measured by serum neutralizing antibody (NAb).

resultsSolicited and unsolicited AEs were mainly mild-to-moderate and transient in all groups, with no meaningful differences in rates between groups. Fecal shedding of challenge viruses in both IPV groups exceeded that of the bOPV group but was not different between IPV and IPV + dmLT groups. High serum NAb responses were observed in both IPV groups, alongside modest levels of fecal neutralization and IgA.

conclusionsAddition of dmLT to IPV administered intramuscularly neither affected humoral nor intestinal immunity nor decreased fecal virus shedding following bOPV challenge. The tolerability of the dose of dmLT used in this study may allow higher doses to be investigated for impact on mucosal immunity. Registered on ClinicalTrials.gov - NCT04232943.

Indexed as

PoliomyelitisPoliovirus Vaccine, InactivatedAdjuvants, ImmunologicAdultAntibodies, NeutralizingHot TemperatureHumansImmunoglobulin APoliovirus Vaccine, OralAdjuvants, ImmunologicAntibodies, NeutralizingImmunoglobulin APoliovirus Vaccine, InactivatedPoliovirus Vaccine, OraldmLTinactivated poliovirus vaccine (IPV)intestinal immunityPoliovirusvaccine

Identifiers

PMID36746739
PMCPMC9996288
OpenAlexW4319223663

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.