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Type: Journal article
Title: A randomized, controlled, phase 1/2 trial of a Neisseria meningitidis serogroup B bivalent rLP2086 vaccine in healthy children and adolescents
Author: Nissen, M.
Marshall, H.
Richmond, P.
Jiang, Q.
Harris, S.
Jones, T.
Jansen, K.
Perez, J.
Citation: Pediatric Infectious Disease Journal, 2013; 32(4):364-371
Publisher: Lippincott Williams & Wilkins
Issue Date: 2013
ISSN: 0891-3668
Statement of
Michael D. Nissen, Helen S. Marshall, Peter C. Richmond, Qin Jiang, Shannon L. Harris, Thomas R. Jones, Kathrin U. Jansen and John L. Perez
Abstract: <h4>Background</h4>Neisseria meningitidis serogroup B (MnB) is a significant cause of invasive meningococcal disease. Factor H binding protein (also known as LP2086) is a conserved outer membrane neisserial lipoprotein that has emerged as a strong candidate protein antigen for MnB vaccination. This study examined the safety, tolerability and immunogenicity of an initial formulation of a bivalent recombinant LP2086 (rLP2086) vaccine in healthy children and adolescents.<h4>Methods</h4>In this randomized, observer-blinded, parallel-group, multicenter trial conducted at 6 centers in Australia, 127 healthy participants aged 8-14 years were assigned to receive 20, 60 or 200 µg of the bivalent rLP2086 vaccine (n = 16, 45 and 45, respectively) or active control (Twinrix, n = 21) at 0, 1 and 6 months. Immunogenicity was assessed before the first dose and 1 month after doses 2 and 3. Local reactions, systemic events and other adverse events were recorded. The primary immunogenicity endpoint was the rate of seroconversion (≥4-fold rise in human complement serum bactericidal assay titer) against MnB strains expressing the homologous A05 or heterologous B02 LP2086 variants.<h4>Results</h4>The bivalent rLP2086 vaccine was generally well-tolerated, with mostly mild to moderate local reactions. The most common adverse events, headache and upper respiratory tract infection, occurred with similar frequency in each group. Post-dose 3 seroconversion rates against strains expressing B02 and A05 variants were 68.8-95.3% for rLP2086 recipients and 0% for Twinrix recipients.<h4>Conclusions</h4>The bivalent rLP2086 vaccine was well-tolerated and immunogenic in healthy children and adolescents, supporting further evaluation as a broadly protective MnB vaccine.
Keywords: meningococcal vaccines; Neisseria meningitidis serogroup B; factor H binding protein; children; adolescents
Rights: © 2013 Lippincott Williams & Wilkins, Inc.
RMID: 0020126428
DOI: 10.1097/INF.0b013e31827b0d24
Appears in Collections:Paediatrics publications

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