Trial reportThe Journal of infection2015
A novel meningococcal outer membrane vesicle vaccine with constitutive expression of FetA: A phase I clinical trial.
Trial report in The Journal of infection, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01640652 (A Phase I, Single Centre, Open-label Dose-escalation Study to Assess the Safety and Immunogenicity of Three Doses of 25µg or 50 µg of Meningococcal Serogroup B Outer Membrane Vesicle Vaccine MenPF-1), which is not on this map. Cited by 32 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.
A Phase I, Single Centre, Open-label Dose-escalation Study to Assess the Safety and Immunogenicity of Three Doses of 25µg or 50 µg of Meningococcal Serogroup B Outer Membrane Vesicle Vaccine MenPF-1
Who cites it
32 citing papers in PubMed, 50 citations in OpenAlex.
- Profiling IgG and IgA antibody responses during vaccination and infection in a high-risk gonorrhoea population.Nature communications · 2024Trial
- Trial
- Pharyngeal carriage of Neisseria species in the African meningitis belt.The Journal of infection · 2016Trial
- Bacterial Extracellular Vesicles in Biomedical Research and Clinical Translation.Microbial biotechnology · 2026Review
- Outer membrane vesicles as a versatile nanoplatform for advanced vaccine development and immunotherapy.Frontiers in immunology · 2026Review
- Review
- Epidemiology of Bacterial Meningitis in the Lombardy Region, Italy, from 2014 to 2024: An Observational, Retrospective Study.Microorganisms · 2025Article
- Bioengineering Outer-Membrane Vesicles for Vaccine Development: Strategies, Advances, and Perspectives.Vaccines · 2025Review
- Genetic and Antigenic Diversity ofPathogens (Basel, Switzerland) · 2025Article
- The global state, trajectory and trends of bacterial extracellular vesicles: a bibliometric and visualized analysis.Frontiers in microbiology · 2025Article
- Dose Determination and Administration of Bacterial Extracellular Vesicles for In Vivo Preclinical Studies.Methods in molecular biology (Clifton, N.J.) · 2024Article
- Genetic, Functional, and Immunogenic Analyses of theJournal of bacteriology · 2023Article
- Emerging role of microbiota derived outer membrane vesicles to preventive, therapeutic and diagnostic proposes.Infectious agents and cancer · 2023Review
- Article
- Viral vectors expressing group B meningococcal outer membrane proteins induce strong antibody responses but fail to induce functional bactericidal activity.The Journal of infection · 2022Article
- Article
- Bioengineering Strategies for Developing Vaccines against Respiratory Viral Diseases.Clinical microbiology reviews · 2022Review
- Extracellular Vesicles as Drug Delivery System for Treatment of Neurodegenerative Disorders: Optimization of the Cell Source.Advanced nanobiomed research · 2021Article
- Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans.Human vaccines & immunotherapeutics · 2021Review
- Surface Engineering ofFrontiers in pharmacology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 4 institutions in 1 country.
Funding
Abstract
objectivesOuter membrane vesicle (OMV) vaccines are used against outbreaks of capsular group B Neisseria meningitidis (MenB) caused by strains expressing particular PorA outer membrane proteins (OMPs). Ferric enterobactin receptor (FetA) is another variable OMP that induces type-specific bactericidal antibodies, and the combination of judiciously chosen PorA and FetA variants in vaccine formulations is a potential approach to broaden protection of such vaccines.
methodsThe OMV vaccine MenPF-1 was generated by genetically modifying N. meningitidis strain 44/76 to constitutively express FetA. Three doses of 25 μg or 50 μg of MenPF-1 were delivered intra-muscularly to 52 healthy adults.
resultsMenPF-1 was safe and well tolerated. Immunogenicity was measured by serum bactericidal assay (SBA) against wild-type and isogenic mutant strains. After 3 doses, the proportion of volunteers with SBA titres ≥1:4 (the putative protective titre) was 98% for the wild-type strain, and 77% for the strain 44/76 FetA(on)PorA(off) compared to 51% in the strain 44/76 FetA(off)PorA(off), demonstrating that vaccination with MenPF-1 simultaneously induced FetA and PorA bactericidal antibodies.
conclusionThis study provides a proof-of-concept for generating bactericidal antibodies against FetA after OMV vaccination in humans. Prevalence-based choice of PorA and FetA types can be used to formulate a vaccine for broad protection against MenB disease.
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What OpenQuestion holds
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.