Trial reportThe Journal of infectious diseases2014
A novel intramuscular bivalent norovirus virus-like particle vaccine candidate--reactogenicity, safety, and immunogenicity in a phase 1 trial in healthy adults.
Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01168401 (Phase 1, Randomized Controlled Dose Escalation, Safety and Immunogenicity Study of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle), which is not on this map. Cited by 86 papers, 2 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, Randomized Controlled Dose Escalation, Safety and Immunogenicity Study of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine Adjuvanted With Monophosphoryl Lipid A (MPL) and Aluminum Hydroxide [Al(OH)3] in Adults
Who cites it
86 citing papers in PubMed, 2 syntheses or guidelines pooled it, 141 citations in OpenAlex.
- Disease burden of norovirus-associated diarrhea among children under 5 years old in China: a meta-analysis.BMC infectious diseases · 2025Pooled 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
- 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
- Safety and immunogenicity of a bivalent norovirus vaccine candidate in infants from 6 weeks to 5 months of age: A phase 2, randomized, double-blind trial.Human vaccines & immunotherapeutics · 2025Trial
- Immunogenicity and tolerability of a bivalent virus-like particle norovirus vaccine candidate in children from 6 months up to 4 years of age: A phase 2 randomized, double-blind trial.Human vaccines & immunotherapeutics · 2023Trial
- Immune responses in healthy adults elicited by a bivalent norovirus vaccine candidate composed of GI.4 and GII.4 VLPs without adjuvant.Frontiers in immunology · 2023Trial
- A randomized, double-blind, placebo-controlled, dose-escalating phase I trial to evaluate safety and immunogenicity of a plant-produced, bivalent, recombinant norovirus-like particle vaccine.Frontiers in immunology · 2022Trial
- 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
- Serological Correlates of Protection against a GII.4 Norovirus.Clinical and vaccine immunology : CVI · 2015Trial
- Norovirus vaccine against experimental human GII.4 virus illness: a challenge study in healthy adults.The Journal of infectious diseases · 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
- Article
- IgA is necessary and sufficient to prevent norovirus infection in mice.Science translational medicine · 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
- Characterization of humoral and cellular immunity induced by mRNA vaccines expressing norovirus VP1 proteins in mice and NHPs.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- Mechanisms of Norovirus Immunity: Implications for Vaccine Design.Annual review of pathology · 2026Review
- Optimized Multi-Epitope Norovirus Vaccines Induce Robust Humoral and Cellular Responses in Mice.Vaccines · 2025Article
26 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 8 institutions in 2 countries.
Funding
Abstract
backgroundNoroviruses are the most important viral causes of gastroenteritis-related morbidity and mortality. A randomized, double-blind, placebo-controlled study evaluated an adjuvanted bivalent intramuscular norovirus virus-like particle (VLP) vaccine.
methodsForty-eight adults aged 18-49 years received either 2 doses containing genotype GI.1 VLP and a consensus GII.4 VLP or 2 doses of placebo. Doses (5 µg, 15 µg, 50 µg, or 150 µg of each VLP) were administered 4 weeks apart in the first stage. Subsequently, 54 adults, aged 18-49 (n=16), 50-64 (n=19), and 65-85 (n=19) years, received 2 doses of vaccine containing 50 µg of each VLP. Total and class-specific antibody responses, as well as histoblood group antigen (HBGA) blocking antibody responses, were measured before and after each dose.
resultsLocal reactions were mainly injection site pain/tenderness, with no reported fever or vaccine-related serious adverse events. One dose of vaccine containing 50 µg of each VLP increased GI.1 geometric mean titers (GMTs) by 118-fold, 83-fold, and 24-fold and increased GII.4 GMTs by 49-fold, 25-fold, and 9-fold in subjects aged 18-49, 50-64, and 65-83 years, respectively. Serum antibody responses peaked at day 7 after the first dose, with no evidence of boosting following a second dose. Most subjects achieved HBGA-blocking antibody titers of ≥200.
conclusionsThe vaccine was well tolerated and immunogenic. Rapid immune response to a single dose may be particularly useful in military personnel and travelers and in the control of outbreaks. Clinical Trials Registration. NCT01168401.
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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.