Bivalent recombinant liopoprotein 2086 vaccine well tolerated, immunogenic against multiple strains
MONDAY, May 7 (HealthDay News) -- A new meningococcus serogroup B vaccine is strongly immunogenic against multiple strains and well tolerated in healthy adolescents, according to a study published online May 7 in The Lancet Infectious Diseases.
Peter C. Richmond, M.B.B.S., from the Princess Margaret Hospital for Children in Subiaco, Australia, and colleagues randomly assigned 511 healthy adolescents to placebo or one of three doses of a vaccine against Neisseria meningitidis serogroup B (recombinant lipoprotein 2086) at zero, two, and six months.
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.
Abstract
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