Trial reportClinical and vaccine immunology : CVI2009
Phase I safety and immunogenicity study of a candidate meningococcal disease vaccine based on Neisseria lactamica outer membrane vesicles.
Trial report in Clinical and vaccine immunology : CVI, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.
- Acinetobacter baumannii as a Model for the Study and Application of Gram-Negative Outer Membrane Vesicles: A Systematic Review.Microbial biotechnology · 2025Pooled it
- Three doses of an experimental detoxified L3-derived lipooligosaccharide meningococcal vaccine offer good safety but low immunogenicity in healthy young adults.Clinical and vaccine immunology : CVI · 2010Trial
- Controlled Human Infection of Healthy Adults With LyophilizedOpen forum infectious diseases · 2026Article
- Bioengineering Outer-Membrane Vesicles for Vaccine Development: Strategies, Advances, and Perspectives.Vaccines · 2025Review
- A novel outer membrane vesicle adjuvant improves vaccine protection against Bordetella pertussis.NPJ vaccines · 2024Article
- Emerging role of microbiota derived outer membrane vesicles to preventive, therapeutic and diagnostic proposes.Infectious agents and cancer · 2023Review
- Review
- A recombinant commensal bacteria elicits heterologous antigen-specific immune responses during pharyngeal carriage.Science translational medicine · 2021Article
- Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans.Human vaccines & immunotherapeutics · 2021Review
- Article
- Genomic characterization of novel Neisseria species.Scientific reports · 2019Article
- Mechanistic research holds promise for bacterial vaccines and phage therapies forDrug design, development and therapy · 2019Review
- Tongue Coating Microbiota Community and Risk Effect on Gastric Cancer.Journal of Cancer · 2018Article
- Article
- 16S rRNA amplicon sequencing identifies microbiota associated with oral cancer, human papilloma virus infection and surgical treatment.Oncotarget · 2016Article
- An antibacterial vaccination strategy based on a glycoconjugate containing the core lipopolysaccharide tetrasaccharide Hep2Kdo2.Nature chemistry · 2016Article
- Outer membrane vesicles as platform vaccine technology.Biotechnology journal · 2015Review
- Seroprevalence of Antibody-Mediated, Complement-Dependent Opsonophagocytic Activity against Neisseria meningitidis Serogroup B in England.Clinical and vaccine immunology : CVI · 2015Article
- Routine vaccination against MenB: considerations for implementation.Human vaccines & immunotherapeutics · 2014Article
- Pseudomonas aeruginosa outer membrane vesicles modulate host immune responses by targeting the Toll-like receptor 4 signaling pathway.Infection and immunity · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Natural immunity to meningococcal disease in young children is associated epidemiologically with carriage of commensal Neisseria species, including Neisseria lactamica. We have previously demonstrated that outer membrane vesicles (OMVs) from N. lactamica provide protection against lethal challenge in a mouse model of meningococcal septicemia. We evaluated the safety and immunogenicity of an N. lactamica OMV vaccine in a phase I placebo-controlled, double-blinded clinical trial. Ninety-seven healthy young adult male volunteers were randomized to receive three doses of either an OMV vaccine or an Alhydrogel control. Subsequently, some subjects who had received the OMV vaccine also received a fourth dose of OMV vaccine, 6 months after the third dose. Injection site reactions were more frequent in the OMV-receiving group, but all reactions were mild or moderate in intensity. The OMV vaccine was immunogenic, eliciting rises in titers of immunoglobulin G (IgG) against the vaccine OMVs, together with a significant booster response, as determined by an enzyme-linked immunosorbent assay. Additionally, the vaccine induced modest cross-reactive immunity to six diverse strains of serogroup B Neisseria meningitidis, including IgG against meningococcal OMVs, serum bactericidal antibodies, and opsonophagocytic activity. The percentages of subjects showing > or =4-fold rises in bactericidal antibody titer obtained were similar to those previously reported for the Norwegian meningococcal OMV vaccine against the same heterologous meningococcal strain panel. In conclusion, this N. lactamica OMV vaccine is safe and induces a weak but broad humoral immune response to N. meningitidis.
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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.