Trial reportThe Journal of infectious diseases2015
Norovirus vaccine against experimental human GII.4 virus illness: a challenge study in healthy adults.
Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01609257 (Phase 1-2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Safety, Immunogenicity, and Efficacy Study in Healthy Adults of Intramuscular Norovirus Bivalent Virus-like Particle Vaccine in Experimental Human Norovirus GII.4 Disease), which is not on this map. Cited by 142 papers, 3 of them syntheses that pooled 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.
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.
Phase 1-2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Safety, Immunogenicity, and Efficacy Study in Healthy Adults of Intramuscular Norovirus Bivalent Virus-like Particle Vaccine in Experimental Human Norovirus GII.4 Disease
Who cites it
142 citing papers in PubMed, 3 syntheses or guidelines pooled it, 274 citations in OpenAlex.
- Foodborne and Food-Handler Norovirus Outbreaks: A Systematic Review.Foodborne pathogens and disease · 2018Pooled it
- Host Genetic Susceptibility to Enteric Viruses: A Systematic Review and Metaanalysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Pooled it
- A decade of norovirus disease risk among older adults in upper-middle and high income countries: a systematic review.BMC infectious diseases · 2015Pooled it
- Safety, tolerability and immunogenicity of a quadrivalent recombinant norovirus vaccine (Pichia pastoris) in participants six weeks of age or older: Phase I/IIa trial.Emerging microbes & infections · 2025Trial
- A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis.Nature communications · 2020Trial
- Production and Clinical Evaluation of Norwalk GI.1 Virus Lot 001-09NV in Norovirus Vaccine Development.The Journal of infectious diseases · 2020Trial
- Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial.JCI insight · 2018Trial
- Safety and Immunogenicity of Different Formulations of Norovirus Vaccine Candidate in Healthy Adults: A Randomized, Controlled, Double-Blind Clinical Trial.The Journal of infectious diseases · 2018Trial
- B-Cell Responses to Intramuscular Administration of a Bivalent Virus-Like Particle Human Norovirus Vaccine.Clinical and vaccine immunology : CVI · 2017Trial
- Impact of Pre-exposure History and Host Genetics on Antibody Avidity Following Norovirus Vaccination.The Journal of infectious diseases · 2017Trial
- Rapid Responses to 2 Virus-Like Particle Norovirus Vaccine Candidate Formulations in Healthy Adults: A Randomized Controlled Trial.The Journal of infectious diseases · 2016Trial
- Norovirus in symptomatic and asymptomatic individuals: cytokines and viral shedding.Clinical and experimental immunology · 2016Trial
- Serological Correlates of Protection against a GII.4 Norovirus.Clinical and vaccine immunology : CVI · 2015Trial
- Broad blockade antibody responses in human volunteers after immunization with a multivalent norovirus VLP candidate vaccine: immunological analyses from a phase I clinical trial.PLoS medicine · 2015Trial
- A simple and powerful test of vaccine waning.American journal of epidemiology · 2026Article
- IgA is necessary and sufficient to prevent norovirus infection in mice.Science translational medicine · 2026Article
- Kinetics of Enteric Pathogen Quantity During Acute Diarrhea in Children in Resource-Limited Settings.Open forum infectious diseases · 2026Article
- Response of dendritic cells and T cells to virus-like particles formed from norovirus viral protein-1 (VP1N) or chimeric molecules containing a fragment of VP1N and polypeptides of echovirus 30.Medical microbiology and immunology · 2026Article
- Mechanisms of Norovirus Immunity: Implications for Vaccine Design.Annual review of pathology · 2026Review
- Current Perspectives and Future Directions in the Immunogenicity Landscape of Norovirus Vaccines.Journal of microbiology and biotechnology · 2025Review
82 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
19 authors at 10 institutions in 2 countries.
Funding
Abstract
backgroundVaccines against norovirus, the leading cause of acute gastroenteritis, should protect against medically significant illness and reduce transmission.
methodsIn this randomized, double-blind, placebo-controlled trial, 18- to 50-year-olds received 2 injections of placebo or norovirus GI.1/GII.4 bivalent vaccine-like particle (VLP) vaccine with 3-O-desacyl-4'-monophosphoryl lipid A (MPL) and alum. Participants were challenged as inpatients with GII.4 virus (4400 reverse transcription polymerase chain reaction [RT-PCR] units), and monitored for illness and infection.
resultsPer protocol, 27 of 50 (54.0%) vaccinees and 30 of 48 (62.5%) controls were infected. Using predefined illness and infection definitions, vaccination did not meet the primary endpoint, but self-reported cases of severe (0% vaccinees vs. 8.3% controls; P = .054), moderate or greater (6.0% vs. 18.8%; P = .068), and mild or greater severity of vomiting and/or diarrhea (20.0% vs. 37.5%; P = .074) were less frequent. Vaccination also reduced the modified Vesikari score from 7.3 to 4.5 (P = .002). Difficulties encountered were low norovirus disease rate, and inability to define illness by quantitative RT-PCR or further antibody rise in vaccinees due to high vaccine-induced titers. By day 10, 11 of 49 (22.4%) vaccinees were shedding virus compared with 17 of 47 (36.2%) placebo recipients (P = .179).
conclusionsBivalent norovirus VLP vaccine reduced norovirus-related vomiting and/or diarrhea; field efficacy studies are planned. Clinical Trials Registration. NCT01609257.
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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.