Pfizer Posts Immunogenicity Data For Meningococcal B+HPV4 Vaccine
Pfizer will present the results of a Phase 2 study investigating the co-administration of its meningococcal group B vaccine, bivalent recombinant LP2086 (rLP2086), together with a quadrivalent human papillomavirus (HPV4) vaccine, at IDWeek 2014 taking place until this weekend in Philadelphia.
The investigational men B group vaccine comprises two recombinant LP2086 antigens or factor H binding proteins (fHBP). The vaccine carries antigens from both subfamilies A and B to provide broader coverage against most of men B strains. Pfizer conducted Phase 2 and 3 trials investigating the vaccine in over 20,000 trial participants. Additional safety and immunogenicity studies are currently in progress. The vaccine received Breakthrough Therapy status as well as Priority Review from the U.S. Food and Drug Administration (FDA).
Data from the randomized Phase 2 study showed that both vaccines elicited immune response after concomitant administration to patients. The trial measured primary immunogenicity endpoints including geometric mean titers (GMTs) against HPV antigens and human complement serum bactericidal assay (hSBA) GMTs. Secondary immunogenicity endpoints included safety and rate of seroconversion to HPV antigens. Criteria for non-inferiority were achieved for bivalent rLP2086 antigens as well as for three out of four HPV4 antigens. Seroconversion rate was reported to be at 99 percent for groups that received the HPV4 vaccine concomitantly with bivalent rLP2086 or with saline.
Dr. Emilio Emini, SVP of Vaccine Research and Development for Pfizer, said, “We are pleased to present data on our investigational meningococcal group B vaccine at IDWeek 2014. We look forward to sharing additional data from the ongoing Phase 2 and Phase 3 clinical studies of our vaccine candidate.”
Meningococcal disease can lead to life-changing, long term, and permanent medical disabilities, including brain damage, hearing loss, limb amputations, or learning disabilities. The disease affects all age groups in the U.S. but it is most prevalent among infants less than one year old, adolescents and young adults, and the elderly.