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   Check publisher's open access policy
ISSN 0264-410X
1873-2518
Publication date 2012-09-21
Sub-type Article (original research)
DOI 10.1016/j.vaccine.2012.07.065
Volume 30
Issue 43
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

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2013 Collection
School of Medicine Publications
Clinical Medical Virology Centre Publications
 
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