Trial reportJournal of the Pediatric Infectious Diseases Society2016
Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents.
Trial report in Journal of the Pediatric Infectious Diseases Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
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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
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020Guideline
- Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine - Advisory Committee on Immunization Practices, 2016.MMWR. Morbidity and mortality weekly report · 2017Guideline
- Trial
- Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study.Pediatric research · 2023Trial
- Modular assembly and immunological evaluation of a promising bioconjugate nanovaccine against Klebsiella pneumoniae O2 serotype.NPJ vaccines · 2025Article
- Engineering strategies and biomedical applications of bacterial extracellular vesicles.Biomaterials translational · 2025Review
- Serum bactericidal activity against circulating and reference strains of meningococcal serogroup B in the United States: A review of the strain coverage of meningococcal serogroup B (MenB) vaccines in adolescents and young adults.Human vaccines & immunotherapeutics · 2023Review
- Review
- Why the Anti-Meningococcal B Vaccination during Adolescence Should Be Implemented in Italy: An Overview of Available Evidence.Microorganisms · 2020Review
- Cost-effectiveness of alternative strategies for vaccination of adolescents against serogroup B IMD with the MenB-FHbp vaccine in Canada.Canadian journal of public health = Revue canadienne de sante publique · 2020Article
- [Health Technology Assessment of meningococcal B vaccine (TrumenbaJournal of preventive medicine and hygiene · 2019Article
- Meningococcal Group B Vaccine For The Prevention Of Invasive Meningococcal Disease Caused ByInfection and drug resistance · 2019Article
- A physician's guide to the 2-dose schedule of MenB-FHbp vaccine.Human vaccines & immunotherapeutics · 2019Review
- A new meningococcal B vaccine for adolescents and adults: characteristics and methods of use.Journal of preventive medicine and hygiene · 2018Article
- Global epidemiology of serogroup B meningococcal disease and opportunities for prevention with novel recombinant protein vaccines.Human vaccines & immunotherapeutics · 2018Review
- Review
- Breadth and Duration of Meningococcal Serum Bactericidal Activity in Health Care Workers and Microbiologists Immunized with the MenB-FHbp Vaccine.Clinical and vaccine immunology : CVI · 2017Article
- Recent Progress in the Prevention of Serogroup B Meningococcal Disease.Clinical and vaccine immunology : CVI · 2017Review
- Meningococcal serogroup B vaccines: Estimating breadth of coverage.Human vaccines & immunotherapeutics · 2017Review
- Article
Corrections and comments
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Authors and funding
15 authors at 8 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNeisseria meningitidis serogroup B (MnB) is a leading cause of invasive meningococcal disease in adolescents and young adults. A recombinant factor H binding protein (fHBP) vaccine (Trumenba(®); bivalent rLP2086) was recently approved in the United States in individuals aged 10-25 years. Immunogenicity and safety of 2- or 3-dose schedules of bivalent rLP2086 were assessed in adolescents.
methodsHealthy adolescents (11 to <19 years) were randomized to 1 of 5 bivalent rLP2086 dosing regimens (0,1,6-month; 0,2,6-month; 0,2-month; 0,4-month; 0,6-month). Immunogenicity was assessed by serum bactericidal antibody assay using human complement (hSBA). Safety assessments included local and systemic reactions and adverse events.
resultsBivalent rLP2086 was immunogenic when administered as 2 or 3 doses; the most robust hSBA responses occurred with 3 doses. The proportion of subjects with hSBA titers ≥1:8 after 3 doses ranged from 91.7% to 95.0%, 98.9% to 99.4%, 88.4% to 89.0%, and 86.1% to 88.5% for MnB test strains expressing vaccine--heterologous fHBP variants A22, A56, B24, and B44, respectively. After 2 doses, responses ranged from 90.8% to 93.5%, 98.4% to 100%, 69.1% to 81.1%, and 70.1% to 77.5%. Geometric mean titers (GMTs) were highest among subjects receiving 3 doses and similar between the 2- and 3-dose regimens. After 2 doses, GMTs trended numerically higher among subjects with longer intervals between the first and second dose (6 months vs 2 and 4 months). Bivalent rLP2086 was well tolerated.
conclusionsBivalent rLP2086 was immunogenic and well tolerated when administered in 2 or 3 doses. Three doses yielded the most robust hSBA response rates against MnB strains expressing vaccine-heterologous subfamily B fHBPs.
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