Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
Pfizer Inc. (NYSE: PFE) announced today the presentation of data from a Phase 2 study of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes contained in the vaccine in adults aged 18 years and older. The presentation was delivered at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, Netherlands. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).
“The safety and immunogenicity results from this study suggest that our 20vPnC candidate, which initiated Phase 3 development in adults last year, could potentially offer comprehensive coverage of additional serotypes causing pneumococcal disease globally and in the U.S. as substantiated by the receipt of FDA’s Breakthrough Therapy Designation,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We believe the full extent of Prevenar 13 protection of adults has yet to be fulfilled. At the same time, there continues to be a global health need to protect against the potential effects of invasive pneumococcal disease and pneumonia caused by additional serotypes not yet covered by existing conjugate vaccines.”
The Phase 2 study was a randomized, active-controlled, double-blinded trial that enrolled 444 adult subjects age 60 to 64. Subjects received a single injection of 20vPnC or Prevnar 13 (Vaccination 1). One month later subjects receiving 20vPnC were given an injection of saline placebo, and subjects receiving Prevnar 13 were given 23-valent polysaccharide vaccine (Vaccination 2). Local reactions and systemic events were recorded for 10 and 7 days respectively after Vaccination 1 and data on adverse events (AEs) were collected for one month following each vaccination. Immunogenicity was assessed by measuring antibody associated with serotype-specific bacterial killing (opsonophagocytic activity [OPA]) prior to vaccination and one month after each vaccination. The study was designed to describe safety and immunogenicity data with 20vPnC in a population of older adults. Given the stage of the study there was no hypothesis testing and data were summarized.