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Neisseria meningitidis serogroup B bivalent factor H binding protein vaccine
Nathan James Brendish1, Robert Charles Read
1NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Mailpoint 218, West Wing, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK.
Abstract:
With the successful development of meningococcal vaccines against other serogroups, disease caused by Neisseria meningitidis serogroup B now accounts for a disproportionate frequency compared with other serogroups, particularly in the US and Europe. Infants and adolescents bear the highest incidence of disease, which typically manifests as meningitis and septicemia. This vaccine profile article examines a bivalent factor H binding protein (fHbp; also known as LP2086) vaccine that has now been approved by the US FDA for use in 10- to 25-year olds. The manufacturer has shelved plans for further investigation of its use in infants because of high rates of fever in Phase I and II trials in that age group.
Insights
A new meningococcal serogroup B vaccine targeting factor H binding protein (fHbp) is approved for 10- to 25-year-olds. Further infant trials were halted due to high fever rates.
Area of Science:
- Microbiology and Immunology
- Vaccine Development and Public Health
Background:
- Neisseria meningitidis serogroup B is a leading cause of bacterial meningitis and septicemia, particularly in adolescents and young adults in the US and Europe.
- Existing meningococcal vaccines have successfully reduced disease from other serogroups, making serogroup B a disproportionate concern.
Purpose of the Study:
- To review the profile of a newly approved bivalent factor H binding protein (fHbp) vaccine against Neisseria meningitidis serogroup B.
- To discuss the vaccine's indication and the reasons for discontinuing infant trials.
Main Methods:
- Review of clinical trial data and regulatory approval information for the fHbp vaccine (LP2086).
- Analysis of safety and efficacy data, focusing on adverse events in different age groups.
Main Results:
- The bivalent fHbp vaccine has received US FDA approval for individuals aged 10 to 25 years.
- Phase I and II trials in infants showed high rates of fever, leading to the discontinuation of further development in this age group.
Conclusions:
- The fHbp vaccine represents a significant advancement in controlling Neisseria meningitidis serogroup B disease in adolescents and young adults.
- The safety concerns regarding fever in infants highlight the need for age-specific vaccine development and evaluation.
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