A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: results of a randomised, controlled, dose-escalation phase-1 trial

Richmond, P. C., Nissen, M. D., Marshall, H. S., Lambert, S. B., Roberton, D., Gruber, W. C., Jones, T. R. and Arora, A. (2012) A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: results of a randomised, controlled, dose-escalation phase-1 trial. Vaccine, 30 43: 6163-6174.


Author Richmond, P. C.
Nissen, M. D.
Marshall, H. S.
Lambert, S. B.
Roberton, D.
Gruber, W. C.
Jones, T. R.
Arora, A.
Total Author Count Override 8
Title A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: results of a randomised, controlled, dose-escalation phase-1 trial
Formatted title A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: results of a randomised, controlled, dose-escalation phase-1 trial
Journal name Vaccine  (ERA 2012 Listed)    (ERA 2010 Rank A)   Check publisher's open access policy
Publication date 2012-09-21
Sub-type Article
DOI 10.1016/j.vaccine.2012.07.065
Volume number 30
Issue number 43
ISSN 0264-410X
1873-2518
Start page 6163
End page 6174
Total pages 12
Place of publication London, United Kingdom
Publisher Elsevier
Collection year 2013
Language eng
Formatted 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 200 μg 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 200 μg 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 200 μg dose levels.
Keyword Meningococcal vaccines
Neisseria meningitidis serogroup B
Bacterial outer membrane proteins
Bactericidal antibodies
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

 
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