Vaccine profile of 4CMenB: a four-component Neisseria meningitidis serogroup B vaccine

Abstract

Invasive meningococcal disease is a severe clinical condition which most commonly presents as sepsis or meningitis and can cause death or major long-term sequelae. Neisseria meningitidis serogroup B (MenB) is one of the major causes of invasive meningococcal disease. The availability of the complete genome sequence of a MenB strain led to the development of a four-component vaccine specific for this pathogen (4CMenB), which has been tested in animals and humans. 4CMenB is shown to be immunogenic in pediatric subjects and is effective in vitro for most of the different MenB strains. However, several problems must still be adequately solved before the vaccine can be universally recommended. Further studies are needed to evaluate the vaccine's coverage over time, duration of protection, the immunogenicity of a simplified administration scheme, and the real incidence of severe rare adverse events. In addition, the effect of 4CMenB on MenB carriers and its cost–effectiveness ratio are needed to more completely describe the characteristics of this vaccine.

Keywords::

• invasive meningococcal disease
• MenB vaccine
• meningococcal vaccines
• Neisseria meningitidis

Financial & competing interests disclosure

The authors declare that they have no conflict of interest and have received no payment for preparing this manuscript. This review was supported by a grant from the Italian Ministry of Health (Bando Giovani Ricercatori 2009). The authors' institution received research grants from Novartis, Pfizer, GSK and Roche. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Invasive meningococcal disease (IMD) is a severe clinical condition which most commonly presents as sepsis and/or meningitis and can cause death or major long-term sequelae.

• Neisseria meningitidis serogroup B (MenB) is one of the major causes of IMD.

• Using reverse vaccinology, a four-component vaccine specific for NmB (4CMenB) was developed.

• 4CMenB has been shown to be immunogenic and able to protect against most infections caused by the different MenB strains in in vitro studies.

• More data are needed to evaluate the coverage of 4CMenB over time, its duration of protection, the immunogenicity of a simplified administration scheme, the actual incidence of severe (but rare) adverse events, the vaccine's effect on MenB carriers and its cost–effectiveness ratio.