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Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/74034

Type: Journal article
Title: Safety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers aged 18-36 months: A phase 1 randomized-controlled clinical trial
Author: Marshall, H.
Richmond, P.
Nissen, M.
Jiang, Q.
Anderson, A.
Jansen, K.
Reynolds, G.
Ziegler, J.
Harris, S.
Jones, T.
Perez, J.
Citation: Pediatric Infectious Disease Journal, 2012; 31(10):1061-1068
Publisher: Lippincott Williams & Wilkins
Issue Date: 2012
ISSN: 0891-3668
Statement of
Responsibility: 
Helen 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
Abstract: BACKGROUND: 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.
Rights: © 2012 Lippincott Williams & Wilkins, Inc.
RMID: 0020122111
DOI: 10.1097/INF.0b013e31826327e4
Appears in Collections:Paediatrics publications
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