Richmond, P.Nissen, M.Marshall, H.Lambert, S.Roberton, D.Gruber, W.Jones, T.Arora, A.2012-10-262012-10-262012Vaccine, 2012; 30(43):6163-61740264-410X0264-410Xhttp://hdl.handle.net/2440/73741Neisseria 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.en© 2012 Elsevier Ltd.HumansNeisseria meningitidis, Serogroup BMeningococcal InfectionsBacterial ProteinsImmunoglobulin GVaccines, SyntheticMeningococcal VaccinesAntibodies, BacterialAntigens, BacterialDouble-Blind MethodAdultComplement System ProteinsFemaleMaleYoung AdultSerum Bactericidal Antibody AssayJournal article002012190910.1016/j.vaccine.2012.07.0650003096167000092-s2.0-8486578974823207Marshall, H. [0000-0003-2521-5166]