As determined by serum bactericidal assays using human complement (hSBA) against eight strains, the researchers found that seroconversion occurred in 67.9 to 100 percent of subjects at the two highest doses. The immune response was strong, with many having titers up to 16. The vaccine was generally well tolerated, with mild-to-moderate pain at the injection site being the most common local reaction. Systemic events were generally mild to moderate and included fatigue and headache. There was one serious vaccine-related adverse event, which resolved without sequelae, after the third dose of the highest dose.
"The bivalent recombinant lipoprotein 2086 vaccine is immunogenic and induces robust hSBA activity against diverse invasive meningococcus serogroup B disease strains, and the vaccine is well tolerated," Richmond and colleagues conclude. "Recombinant lipoprotein 2086 vaccine is a promising candidate for broad protection against invasive meningococcus serogroup B disease."
Several authors disclosed financial ties to pharmaceutical companies, including Wyeth and Pfizer, both of which funded the study.