Pfizer's (PFE -1.1%) recombinant meningococcal B vaccine bivalent rLP2086 shows positive top-line results in two Phase 2 clinical trials. In both studies, the vaccine generated bactericidal responses against meningococcal serogroup B test strains following two or three doses. In the trial evaluating the co-administration of the vaccine with dTaP-IPV, no effect was observed regarding the immune response to dTaP-IPV.
One Phase 2 trial assessed the safety, tolerability and immunogenicity of bivalent rLP2086 in healthy adolescents aged 11 to 18 years in two- and three-dose regimens. The other Phase 2 evaluated the effects of co-administration of bivalent rLP2086 with a dTaP-IPV vaccine in healthy adolescents aged 11 - 18 years.
In March 2014 the FDA designated rLP2086 a Breakthrough Therapy. Pfizer plans to submit its BLA for the product within the next several months.