Trial reportPLoS medicine2015
Broad blockade antibody responses in human volunteers after immunization with a multivalent norovirus VLP candidate vaccine: immunological analyses from a phase I clinical trial.
Trial report in PLoS medicine, 2015. 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 90 papers.
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
90 citing papers in PubMed.
- Production and Clinical Evaluation of Norwalk GI.1 Virus Lot 001-09NV in Norovirus Vaccine Development.The Journal of infectious diseases · 2020Trial
- Analyzing the Human Serum Antibody Responses to a Live Attenuated Tetravalent Dengue Vaccine Candidate.The Journal of infectious diseases · 2018Trial
- 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
- Symmetry-breaking antibody binding reveals extensive capsid malleability in pandemic human norovirus.Research square · 2026Article
- Antigenic mapping of H2 influenza viruses recognized by ferret and human sera and predicting antigenically significant sites.mSphere · 2026Article
- Sustained persistence of blockade antibodies against emerging GII.4 and GII.17 noroviruses revealed by a 5-year community-based serological study.Frontiers in cellular and infection microbiology · 2026Article
- Profiling Norovirus Antibody Specificity and Function Using Luciferase Immunoprecipitation System (LIPS) Assays.Methods in molecular biology (Clifton, N.J.) · 2026Article
- Article
- Antigenic Mapping of H2 Influenza Viruses recognized by Ferret and Human Sera and Predicting Antigenically Significant Sites.bioRxiv : the preprint server for biology · 2025Article
- Highly variable antigenic site located at the apex of GII.4 norovirus capsid protein induces cross-reactive blocking antibodies in a variant-specific manner.Journal of virology · 2025Article
- Norovirus replication, host interactions and vaccine advances.Nature reviews. Microbiology · 2025Review
- Integrated in-silico design and in vivo validation of multi-epitope vaccines for norovirus.Virology journal · 2025Article
- Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults.Vaccines · 2025Article
- Bivalent norovirus mRNA vaccine elicits cellular and humoral responses protecting human enteroids from GII.4 infection.NPJ vaccines · 2024Article
- Development of a broad-spectrum therapeutic Fc-nanobody for human noroviruses.Journal of virology · 2024Article
- Current trends and new approaches for human norovirus replication in cell culture: a literature review.Archives of virology · 2024Review
- Mapping human norovirus antigens during infection reveals the breadth of the humoral immune response.NPJ vaccines · 2023Article
- An Overview of the Public Health Challenges in Diagnosing and Controlling Human Foodborne Pathogens.Vaccines · 2023Review
- Emergent variant modeling of the serological repertoire to norovirus in young children.Cell reports. Medicine · 2023Article
30 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
12 authors.
Funding
Abstract
backgroundHuman noroviruses (NoVs) are the primary cause of acute gastroenteritis and are characterized by antigenic variation between genogroups and genotypes and antigenic drift of strains within the predominant GII.4 genotype. In the context of this diversity, an effective NoV vaccine must elicit broadly protective immunity. We used an antibody (Ab) binding blockade assay to measure the potential cross-strain protection provided by a multivalent NoV virus-like particle (VLP) candidate vaccine in human volunteers. METHODS AND
findingsSera from ten human volunteers immunized with a multivalent NoV VLP vaccine (genotypes GI.1/GII.4) were analyzed for IgG and Ab blockade of VLP interaction with carbohydrate ligand, a potential correlate of protective immunity to NoV infection and illness. Immunization resulted in rapid rises in IgG and blockade Ab titers against both vaccine components and additional VLPs representing diverse strains and genotypes not represented in the vaccine. Importantly, vaccination induced blockade Ab to two novel GII.4 strains not in circulation at the time of vaccination or sample collection. GII.4 cross-reactive blockade Ab titers were more potent than responses against non-GII.4 VLPs, suggesting that previous exposure history to this dominant circulating genotype may impact the vaccine Ab response. Further, antigenic cartography indicated that vaccination preferentially activated preexisting Ab responses to epitopes associated with GII.4.1997. Study interpretations may be limited by the relevance of the surrogate neutralization assay and the number of immunized participants evaluated.
conclusionsVaccination with a multivalent NoV VLP vaccine induces a broadly blocking Ab response to multiple epitopes within vaccine and non-vaccine NoV strains and to novel antigenic variants not yet circulating at the time of vaccination. These data reveal new information about complex NoV immune responses to both natural exposure and to vaccination, and support the potential feasibility of an efficacious multivalent NoV VLP vaccine for future use in human populations.
trial registrationClinicalTrials.gov NCT01168401.
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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.