Vaxcyte Advances 31-Valent Pneumococcal Vaccine to Phase 3 Trials Following Positive Phase 1/2 Results

VAX-31 Phase 1/2 Study Results:
Vaxcyte has announced positive topline data from the Phase 1/2 study of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) designed to prevent invasive pneumococcal disease (IPD) in adults aged 50 and older.

Safety and Immunogenicity:
The vaccine was well-tolerated across all doses, with a safety profile comparable to Prevnar 20. It elicited strong immune responses for all 31 serotypes, surpassing regulatory immunogenicity benchmarks at middle and high doses.

Phase 3 Trials:
Based on these results, VAX-31 will advance to a pivotal Phase 3 study in adults, expected to initiate by mid-2025, with topline data anticipated in 2026.

Pediatric Studies:
A pediatric Phase 2 study for VAX-31 is planned to commence in early 2025 following regulatory approval.

Vaccine Coverage:
VAX-31 is designed to provide coverage for approximately 95% of IPD circulating in the U.S. adult population, addressing a significant public health need.

Vaxcyte’s Pipeline:
The company is also progressing with VAX-24, another pneumococcal vaccine candidate, and has other vaccines in development for Group A Strep, periodontitis, and Shigella.