20-Valent Pneumococcal Conjugate Vaccine Candidate Posts Positive Phase 2 Data
Pfizer Inc. announced positive data from a Phase 2 clinical study of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077.
The PF-06482077 20vPnC vaccine candidate includes the 13 serotypes contained in Prevnar 13, plus 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).
The 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in adults in the U.S. and globally, says Pfizer in a press release.
The 7 new serotypes included in 20vPnC are global causes of invasive pneumococcal disease and are associated with high case-fatality rates, antibiotic resistance and/or meningitis.
This 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 vaccine.
Robust opsonophagocytic activity (OPA) responses were observed for all 20 vaccine serotypes in the 20vPnC group.
The OPA geometric mean fold-rises from baseline ranged from 6.1 to 68.6 for the serotypes in common with Prevnar 13, and 9 to 112.2 for the seven additional serotypes not included in Prevnar 13.
No deaths or serious AEs considered related to the vaccine were reported in the study. The overall safety profile of 20vPnC in this study was consistent with historical experience with Prevnar 13.
“The safety and immunogenicity results from this study suggest that our 20vPnC candidate could potentially offer comprehensive coverage of additional serotypes causing pneumococcal disease,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.
Pfizer has begun enrollment in three Phase 3 trials (NCT03828617, NCT03835975, and NCT03760146) evaluating 20vPnC in adults. Combined, these three trials will enroll more than 6,000 adult subjects, including populations of vaccine-naïve adults and adults with prior pneumococcal vaccination.
On September 20, 2018, Pfizer announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for 20vPnC for the prevention of invasive disease and pneumonia in adults age 18 years and older.
Previously, the FDA granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years and older.
Additionally, in May 2017 the FDA granted Fast Track status for a pediatric indication for 20vPnC and clinical development is in progress.
Recent pneumococcal vaccine news:
- 15-Valent Pneumococcal Conjugate Vaccine Granted Breakthrough Status
- Switching to PCV13 Delivered Positive Benefits
Pneumococcal infections can range from ear and sinus infections to pneumonia and bloodstream infections. Children younger than 2 years old and adults 65 years or older are among those most at risk for disease, says the Centers for Disease Control and Prevention.
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