Vaxcyte Publishes Positive Results of VAX-31 Clinical Study
The company states: "Vaxcyte announced the publication of results from the positive VAX-31 adult Phase 1/2 clinical study in the journal The Lancet Infectious Diseases. The study evaluated the safety, tolerability and immunogenicity of VAX-31, the Company's next-generation 31-valent pneumococcal conjugate vaccine candidate, for the prevention of invasive pneumococcal disease and pneumonia compared to one of the current standard-of-care vaccines, Prevnar 20, in healthy adults aged 50 years and older. Based on the positive results of this Phase 1/2 study, VAX-31 is currently being evaluated in the OPUS Phase 3 adult program. The study results showed that VAX-31 was observed to be well tolerated and demonstrated a safety profile similar to PCV20 through the full six-month evaluation period at all doses studied. At all doses studied, VAX-31 demonstrated robust opsonophagocytic activity and immunoglobulin G (IgG) immune responses, with high geometric mean concentrations across all 31 serotypes. The VAX-31 High Dose, which is currently being evaluated in the OPUS Phase 3 program, met or exceeded the OPA response non-inferiority criteria for all 20 serotypes common with PCV20 and met the superiority criteria for the 11 incremental serotypes unique to VAX-31 and not in PCV20. The VAX-31 High Dose average OPA immune responses were greater for 18 of 20 serotypes compared to PCV20 (geometric mean ratio greater than 1.0), with seven of these serotypes achieving statistically higher immune responses3 compared to PCV20."
