Evidence map›Paper›PMID 37435073›Full record

Trial reportFrontiers in immunology2023

Immune responses in healthy adults elicited by a bivalent norovirus vaccine candidate composed of GI.4 and GII.4 VLPs without adjuvant.

Gwenn Waerlop, Yorick Janssens, Bart Jacobs, Franziska Jarczowski, André Diessner, Geert Leroux-Roels, Victor Klimyuk, Isabel Leroux-Roels, Frank Thieme

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05508178 (A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of a Plant-Produced, Bivalent, Recombinant Norovirus-Like Particle Vaccine, Administered Intramuscularly to Healthy Adults Aged 18 to 40 Years), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 20% 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.

NCT05508178 phase1completednot on this map

A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of a Plant-Produced, Bivalent, Recombinant Norovirus-Like Particle Vaccine, Administered Intramuscularly to Healthy Adults Aged 18 to 40 Years

TypeinterventionalSponsorIcon Genetics GmbHRan2020 to 2021Enrolled60ConditionsNorovirusArmsNorovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg), Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg), Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. 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

9 authors at 1 institution in 1 country.

Gwenn WaerlopCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.
Yorick JanssensCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.
Bart JacobsCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.
Franziska JarczowskiIcon Genetics GmbH, a Denka Company, Halle, Germany.
André DiessnerIcon Genetics GmbH, a Denka Company, Halle, Germany.
Geert Leroux-RoelsCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.
Victor KlimyukIcon Genetics GmbH, a Denka Company, Halle, Germany.
Isabel Leroux-RoelsCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.
Frank ThiemeIcon Genetics GmbH, a Denka Company, Halle, Germany.
Ghent University Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development of an efficacious vaccine against norovirus is of paramount importance given its potential to reduce the global burden of norovirus-associated morbidity and mortality. Here, we report a detailed immunological analysis of a phase I, double-blind, placebo-controlled clinical trial performed on 60 healthy adults, ages 18 to 40. Total serum immunoglobulin and serum IgA against vaccine strains and cross-reactive serum IgG against non-vaccine strains were measured by enzyme immunoassays, whereas cell-mediated immune responses were quantified using intracellular cytokine staining by flow cytometry. A significant increase in humoral and cellular responses, e.g., IgA and CD4 Clinical trial registration: https://clinicaltrials.gov, identifier NCT05508178. EudraCT number: 2019-003226-25.

Indexed as

Adjuvants, ImmunologicNorovirusAdjuvants, PharmaceuticAdultHumansImmunoglobulin AImmunoglobulin GVaccines, CombinedAdjuvants, ImmunologicAdjuvants, PharmaceuticImmunoglobulin AImmunoglobulin GVaccines, Combinedclinical trialimmunogenicitynorovirusplant-producedvaccinevirus-like particle

Identifiers

PMID37435073
PMCPMC10331465
OpenAlexW4382135244

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.