Safety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers aged 18-36 months: A phase 1 randomized-controlled clinical trial

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dc.contributor.authorMarshall, H.
dc.contributor.authorRichmond, P.
dc.contributor.authorNissen, M.
dc.contributor.authorJiang, Q.
dc.contributor.authorAnderson, A.
dc.contributor.authorJansen, K.
dc.contributor.authorReynolds, G.
dc.contributor.authorZiegler, J.
dc.contributor.authorHarris, S.
dc.contributor.authorJones, T.
dc.contributor.authorPerez, J.
dc.date.issued2012
dc.description.abstractBACKGROUND: A bivalent, recombinant, factor H–binding protein (rLP2086) vaccine was developed to protect against invasive Neisseria meningitidis serogroup B (MnB) in children and adolescents. METHODS: Healthy toddlers (N = 99) were enrolled to 3 ascending dose-level cohorts (20, 60 or 200 μg). Within each cohort (n = 33), subjects were randomized to receive an initial formulation of the bivalent rLP2086 vaccine at 0, 1 and 6 months or hepatitis A vaccine/placebo control (2:1 ratio). Reactogenicity was assessed by parental reporting of local and systemic reactions using electronic diaries and reports of unsolicited adverse events. Immunogenicity was assessed by serum bactericidal activity assay using human complement and rLP2086-specific IgG binding. RESULTS: The vaccine was considered to be well tolerated. Tenderness was the most frequently reported local reaction. Upper respiratory tract infection was the most commonly reported adverse event and occurred more frequently in the control group. Three cases (200 μg dose) of severe erythema that did not interfere with limb movement were reported. Four toddlers developed fever >40.0°C, 3 in the 200 μg group and 1 in the 60 μg group. Postdose 3, seroconversion (serum bactericidal activity assay using human complement ≥4-fold rise from baseline) was observed in 61.1–88.9% of participants against MnB strains expressing LP2086 variants homologous or nearly homologous to vaccine antigens and 11.1–44.4% against MnB strains expressing heterologous LP2086 variants. Seroconversion was observed in 77.8–100% of participants against additional, exploratory MnB strains expressing vaccine-homologous or heterologous LP2086 variants. CONCLUSIONS: This study shows that the bivalent rLP2086 vaccine is well tolerated and immunogenic in toddlers.
dc.description.statementofresponsibilityHelen S. Marshall, Peter C. Richmond, Michael D. Nissen, Qin Jiang, Annaliesa S. Anderson, Kathrin U. Jansen, Graham Reynolds, John B. Ziegler, Shannon L. Harris, Thomas R. Jones and John L. Perez
dc.identifier.citationThe Pediatric Infectious Disease Journal, 2012; 31(10):1061-1068
dc.identifier.doi10.1097/INF.0b013e31826327e4
dc.identifier.issn0891-3668
dc.identifier.issn1532-0987
dc.identifier.orcidMarshall, H. [0000-0003-2521-5166]
dc.identifier.urihttp://hdl.handle.net/2440/74034
dc.language.isoen
dc.publisherLippincott Williams & Wilkins
dc.rights© 2012 Lippincott Williams & Wilkins, Inc.
dc.source.urihttps://doi.org/10.1097/inf.0b013e31826327e4
dc.subjectHumans
dc.subjectNeisseria meningitidis, Serogroup B
dc.subjectMeningococcal Infections
dc.subjectBacterial Proteins
dc.subjectImmunoglobulin G
dc.subjectVaccines, Synthetic
dc.subjectMeningococcal Vaccines
dc.subjectAntibodies, Bacterial
dc.subjectAntigens, Bacterial
dc.subjectPlacebos
dc.subjectVaccination
dc.subjectBlood Bactericidal Activity
dc.subjectChild, Preschool
dc.subjectInfant
dc.subjectComplement System Proteins
dc.subjectFemale
dc.subjectMale
dc.subjectDrug-Related Side Effects and Adverse Reactions
dc.titleSafety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers aged 18-36 months: A phase 1 randomized-controlled clinical trial
dc.typeJournal article
pubs.publication-statusPublished

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