Evidence map›Paper›PMID 20979455›Full record

Trial reportThe Journal of infectious diseases2010

Adjuvanted intranasal Norwalk virus-like particle vaccine elicits antibodies and antibody-secreting cells that express homing receptors for mucosal and peripheral lymphoid tissues.

Samer S El-Kamary, Marcela F Pasetti, Paul M Mendelman, Sharon E Frey, David I Bernstein, John J Treanor, Jennifer Ferreira, Wilbur H Chen, Richard Sublett, Charles Richardson and 3 more

Erratum issuedOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 121 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
121citing papers in PubMed, 1 pooled it
9.5field-weighted citation impact, top 1% 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.

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

121 citing papers in PubMed, 1 synthesis or guideline pooled it, 221 citations in OpenAlex.

  1. Mucosal immunity and vaccine development.Signal transduction and targeted therapy · 2026
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  16. Frontiers in immunology · 2025
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61 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Samer S El-KamaryDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. selkamar@epi.umaryland.edu
Marcela F Pasetti
Paul M Mendelman
Sharon E Frey
David I Bernstein
John J Treanor
Jennifer Ferreira
Wilbur H Chen
Richard Sublett
Charles Richardson
Robert F Bargatze
Marcelo B Sztein
Carol O Tacket
University of Maryland, Baltimore · USUniversity of Rochester Medical Center · USCincinnati Children's Hospital Medical Center · USSaint Louis University · US

Funding

Zonulin Antibodies in Intestinal Permeabilitiy in IDDMM01RR016500 · NCRR · UNIVERSITY OF MARYLAND BALTIMORE · PI OSWALD, LYNN M · 2002 to 2009
$20.2M
NCRR NIH HHS M01 RR016500
6 · The paper itself

Abstract

backgroundNoroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide.

methodsWe conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18-49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50- and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors.

resultsThe most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8- and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50- or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues.

conclusionsThe intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study.

Indexed as

Viral VaccinesAdjuvants, ImmunologicAdministration, IntranasalAdolescentAdultAntibodies, ViralAntibody-Producing CellsCaliciviridae InfectionsChitosanDouble-Blind MethodGastroenteritisHemagglutination Inhibition TestsHumansLipid ALymphoid TissueMiddle AgedAdjuvants, ImmunologicAntibodies, ViralChitosanLipid Amonophosphoryl lipid AReceptors, Lymphocyte HomingViral Vaccines

Identifiers

PMID20979455
PMCPMC3722871
OpenAlexW2116486619

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.