Broad meningitis vaccine on the horizon
A new vaccine could prevent around 90% of meningitis cases, results of an international randomised placebo-controlled phase II trial indicate.
When tested in more than 500 healthy adolescents, the bivalent recombinant lipoprotein 2086 vaccine was immunogenic, induced robust activity against diverse strains of meningococcal serogroup B, and was well tolerated.
"Our data suggest that this vaccine is a promising and broadly protective meningococcal serogroup B vaccine candidate," write Dr Peter Richmond (Princess Margaret Hospital for Children, Subiaco, Australia) and co-authors in The Lancet Infectious Diseases. "Future and ongoing clinical trials will define the reactogenicity, breadth of coverage, and robustness of immunological protection afforded by the vaccine."
The vaccine was designed to protect against Neisseria meningitides serogroup B, which is responsible for 87% of bacterial meningitis cases in England and Wales. Currently available vaccines protect against other serogroups, but there is a "major unmet need" for a broadly protective vaccine, says the team.
The researchers recruited 539 healthy adolescents from 25 sites in Australia, Poland and Spain and randomly assigned them to receive ascending doses of vaccine (60, 120 or 200 µg) or placebo at 0, 2 and 6 months.
The vaccine had an "acceptable" safety profile and the most common reaction was mild-to-moderate injection site pain. There was also one anaphylactic reaction, which the researchers say warrants further investigation. With regard to immunogenicity, between 80% and 100% of participants achieved assay titres that correlated with protection after the third dose. There was no dose-response relationship, however.
"The choice of the strains for future serum bactericidal assays should also account for global and local epidemiological distributions of the alleles that encode factor H binding protein," the researchers conclude. "These data would be crucial for future recommendations for the use of the vaccine because genetically diverse isolates might circulate in different regions."
GP News is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012
By Joanna Lyford