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|Title:||A bivalent Neisserie meningitidis recombinant lipidated factor H binding protein vaccine in young adults: results of a randomised, controlled, dose-escalation phase 1 trial|
|Citation:||Vaccine, 2012; 30(43):6163-6174|
|Publisher:||Elsevier Sci Ltd|
|P.C. Richmond, M.D. Nissen, H.S. Marshall, S.B. Lambert, D. Roberton, W.C. Gruber, T.R. Jones and A. Arora|
|Abstract:||Neisseria meningitidis is a leading cause of meningitis and septicaemia, but a broadly-protective vaccine against endemic serogroup B disease is not licensed and available. The conserved, outer-membrane lipoprotein factor H binding protein (fHBP, also known as LP2086) is expressed as one of two subfamily variants in virtually all meningococci. This study investigated the safety, tolerability, and immunogenicity of a recombinant-expressed bivalent fHBP (r-fHBP) vaccine in healthy adults. Participants (N=103) aged 18-25 years were recruited into three ascending dose level cohorts of 20, 60, and 200μg of a bivalent r-fHBP vaccine formulation and randomised to receive vaccine or placebo at 0, 1, and 6 months. The vaccine was well tolerated. Geometric mean titres (GMTs) for r-fHBP subfamily-specific IgG antibodies increased 19-168-fold from pre-vaccination to post-dose 2 in a dose level-dependent manner. In addition, robust serum bactericidal assay using human complement (hSBA) responses for strains expressing both homologous and heterologous fHBP variants were observed. After three vaccinations, 16-52% of the placebo group and 47-90%, 75-100%, and 88-100%, of the 20, 60, and 200μg dose levels, respectively, had seroprotective (≥ 1:4) hSBA titres against six serogroup B strains. The bivalent r-fHBP vaccine was well tolerated and induced robust bactericidal activity against six diverse serogroup B strains in young adults at the 60 and 200μg dose levels.|
|Keywords:||Humans; Neisseria meningitidis, Serogroup B; Meningococcal Infections; Bacterial Proteins; Immunoglobulin G; Vaccines, Synthetic; Meningococcal Vaccines; Antibodies, Bacterial; Antigens, Bacterial; Double-Blind Method; Adult; Complement System Proteins; Female; Male; Young Adult; Serum Bactericidal Antibody Assay|
|Rights:||© 2012 Elsevier Ltd.|
|Appears in Collections:||Paediatrics publications|
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