eClinical Technology and Industy News

Vaxcyte Doses First Participants in Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants

— Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by 2025 —

— The Nine Incremental Serotypes in VAX-24 Cover an Additional 20-25 Percent of Strains Causing Invasive Pneumococcal Disease Over the Current Standard-of-Care PCV in Infants —

Excerpt from the Press Release:

SAN CARLOS, Calif., March 30, 2023 (GLOBE NEWSWIRE) — Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today 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 (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). 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.

“The initiation of our Phase 2 clinical study in infants is a significant advancement for VAX-24, which we believe has the potential to deliver a best-in-class profile with broader coverage and better immune responses relative to the standard-of-care today,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte.

Click the button below to read the entire Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary EDC Platforms

Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?