Vaxcyte doses first participants in Phase 2 study of VAX-24

Vaxcyte announced that the first participants were dosed in the Phase 2 study of VAX-24 in healthy infants. This study will evaluate the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine candidate designed to prevent invasive pneumococcal disease. The Company expects to share topline data from the primary three-dose immunization series of the Phase 2 study by 2025. Vaxcyte’s Phase 2 infant study is being conducted in two stages and compares VAX-24 to the broadest standard-of-care PCV, which is currently PCV15. Stage 1 of the study, which is now currently underway, is evaluating the safety and tolerability of a single injection of VAX-24 at three dose levels and compared to PCV15 in approximately 48 infants in a dose-escalation approach. The Stage 2 portion will evaluate the safety, tolerability and immunogenicity of VAX-24 at the same three dose levels and compared to PCV15 in approximately 750 infants. The study design includes a primary immunization series consisting of three doses followed by a subsequent booster dose.