Pfizer announced positive results from two Phase II studies of its investigational recombinant vaccine candidate for the prevention of invasive meningococcal disease.
In both studies, the vaccine bivalent rLP2086 was shown to generate bactericidal responses in 10 to 25 year olds against a variety of meningococcal serogroup B test strains following either two or three doses. In the study investigating co-administration of the vaccine and dTaP-IPV (diphtheria, tetanus, pertussis and inactivated polio vaccine), no adverse impact was demonstrated on dTaP-IPV vaccine’s immune response.
Neisseria meningitidis causes an estimated half million cases of meningococcal disease around the world every year. A majority of invasive meningococcal disease worldwide can be attributed to five N. meningitidis serogroups. Between 10 and 15 percent of affected patients die of the disease in spite of available antibiotic treatments and 11 to 19 percent of those who survive experience long-term disabilities.
The investigational meningococcal B vaccine bivalent rLP2086 targets LP2086, or factor H binding protein, found on the bacteria’s surface. A previous Phase II study demonstrated efficacy in inducing bactericidal antibodies broadly active against meningococcal B bacteria in patients 11 to 18 years old. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy status to the investigational vaccine in March 2014.
Dr. Emilio Emini, SVP of Vaccine R&D for Pfizer, said that meningococcus disease remains deadly and indeterminable. A preventive approach in treatment remains crucial to maximize positive patient outcomes. “We are encouraged by the safety and tolerability data for our investigational vaccine candidate, bivalent rLP2086, and its potential to help prevent this devastating disease. We look forward to continuing the development of this critically-needed vaccine and working with regulatory authorities to make it available to adolescents and young adults.”
The company presented study results at the 32nd Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID 2014).