Trial reportThe Journal of infectious diseases2018
Safety and Immunogenicity of Different Formulations of Norovirus Vaccine Candidate in Healthy Adults: A Randomized, Controlled, Double-Blind Clinical Trial.
Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02038907 (A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults), which is not on this map. Cited by 42 papers, 1 of them a synthesis 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.
A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults
Who cites it
42 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Population-Level Human Secretor Status Is Associated With Genogroup 2 Type 4 Norovirus Predominance.The Journal of infectious diseases · 2020Pooled 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
- 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
- Norovirus replication, host interactions and vaccine advances.Nature reviews. Microbiology · 2025Review
- Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults.Vaccines · 2025Article
- Article
- A quadrivalent norovirus vaccine based on a chimpanzee adenovirus vector induces potent immunity in mice.Virologica Sinica · 2024Article
- Development of a broad-spectrum therapeutic Fc-nanobody for human noroviruses.Journal of virology · 2024Article
- Noroviruses: Evolutionary Dynamics, Epidemiology, Pathogenesis, and Vaccine Advances-A Comprehensive Review.Vaccines · 2024Review
- The Impact of Norovirus on Children and Adolescents: Implications for Ongoing Vaccine Development.Current pediatrics reports · 2024Review
- Structures of honeybee-infecting Lake Sinai virus reveal domain functions and capsid assembly with dynamic motions.Nature communications · 2023Article
- Unraveling the interplay between norovirus infection, gut microbiota, and novel antiviral approaches: a comprehensive review.Frontiers in microbiology · 2023Review
- 6-Valent Virus-Like Particle-Based Vaccine Induced Potent and Sustained Immunity Against Noroviruses in Mice.Frontiers in immunology · 2022Article
- Norovirus Vaccines: Current Clinical Development and Challenges.Pathogens (Basel, Switzerland) · 2021Review
- Review
- Norovirus Protease Structure and Antivirals Development.Viruses · 2021Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: We investigated safety and immunogenicity of 1-2 doses of different bivalent virus-like particle (VLP) norovirus vaccine candidate (NoV) formulations in healthy 18- to 64-year-olds. Methods: On days 1 and 28, participants (n = 420) randomized to 14 equal groups received intramuscular control vaccine (hepatitis A) or 1 of 11 NoV formulations containing varying dosages of GI.1 and GII.4c genotype VLP antigens with aluminum hydroxide [Al(OH)3], and 0 μg, 15 μg, or 50 μg monophosphoryl lipid A (MPL). Immunogenicity was assessed on days 1, 28, 56, 208 and 393. Solicited local and systemic reactions were recorded for 7 days, unsolicited adverse events (AEs) until day 56, and serious AEs throughout the trial. Results: All NoV formulations induced similar increases in pan-immunoglobulin, immunoglobulin A, and histo-blood group binding antigen-blocking antibodies by day 56, mostly after 1 dose, that persisted above baseline to day 393. Higher GI.1 content interfered with GII.4c responses, and responses did not benefit from MPL. Overall reactogenicity consisted of mainly mild injection site pain, headache, and fatigue. No vaccine-related serious AEs were reported. Conclusions: All candidate NoV formulations were well tolerated. Overall, 15 μg GI.1/50 μg GII.4c elicited the best balance of immunogenicity with no clear benefit of MPL, and is the candidate formulation being taken forward in clinical development. Clinical Trials Registration: NCT02038907.
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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.