Meningitis B Vaccine Shows Promise
- By BSTQ Staff
Researchers have concluded a Phase II study of an investigational vaccine against group B Neisseria meningitidis, which shows promising results. The bivalent vaccine uses lipoprotein 2086, a surface-exposed and immunogenetic factor H binding protein that is present in at least 98 percent of all meningococcal group B strains, as well as in an equal number of variants from families A and B.
In the study, 589 adolescents from 25 sites across Australia, Poland and Spain were randomly assigned to receive one of three vaccine doses (60 μg, 120 μg, or 200 μg) or a placebo injection administered at zero, two and six months; 511 participants received all three doses. Results showed that all three doses produced an immune response in 80 percent to 100 percent of participants, depending on the dose and strain tested. The 120-μg and 200-μg vaccine doses were similarly effective. Mild to moderate injection site pain was common and occurred more frequently among participants receiving the vaccine, lasting a mean of two to three days. The most common systemic events were mild to moderate fatigue, fever and headache that lasted one to three days. However, adverse event incidence and severity did not increase with subsequent vaccinations. Only one serious adverse event was considered related to the study vaccine: A boy aged 13 years experienced a sudden severe headache and vomiting within an hour of the third dose.
“Our data suggest that this vaccine is a promising and broadly protective meningococcal serogroup B vaccine candidate…. If additional studies show similar immunogenicity and tolerability, this vaccine might help to reduce the global burden of invasive meningococcal disease,” wrote lead author Peter Richmond, MBBS, from the University of Western Australia School of Paediatrics and Child Health, Vaccine Trials Group, Telethon Institute for Child Health Research, Princess Margaret Hospital for Children, Subiaco and colleagues. The study was published online on May 7, 2012, in the journal The Lancet.
