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https://hdl.handle.net/2440/80219
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dc.contributor.author | Nissen, M. | - |
dc.contributor.author | Marshall, H. | - |
dc.contributor.author | Richmond, P. | - |
dc.contributor.author | Jiang, Q. | - |
dc.contributor.author | Harris, S. | - |
dc.contributor.author | Jones, T. | - |
dc.contributor.author | Jansen, K. | - |
dc.contributor.author | Perez, J. | - |
dc.date.issued | 2013 | - |
dc.identifier.citation | The Pediatric Infectious Disease Journal, 2013; 32(4):364-371 | - |
dc.identifier.issn | 0891-3668 | - |
dc.identifier.issn | 1532-0987 | - |
dc.identifier.uri | http://hdl.handle.net/2440/80219 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | Michael D. Nissen, Helen S. Marshall, Peter C. Richmond, Qin Jiang, Shannon L. Harris, Thomas R. Jones, Kathrin U. Jansen and John L. Perez | - |
dc.language.iso | en | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.rights | © 2013 Lippincott Williams & Wilkins, Inc. | - |
dc.source.uri | http://dx.doi.org/10.1097/inf.0b013e31827b0d24 | - |
dc.subject | meningococcal vaccines | - |
dc.subject | Neisseria meningitidis serogroup B | - |
dc.subject | factor H binding protein | - |
dc.subject | children | - |
dc.subject | adolescents | - |
dc.title | A randomized, controlled, phase 1/2 trial of a Neisseria meningitidis serogroup B bivalent rLP2086 vaccine in healthy children and adolescents | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1097/INF.0b013e31827b0d24 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Marshall, H. [0000-0003-2521-5166] | - |
Appears in Collections: | Aurora harvest Paediatrics publications |
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