Vaxcyte – a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases – recently announced that the ongoing Phase 2 study of VAX-24 in healthy infants is advancing to the second and final stage of the study. The independent Data Safety Monitoring Board approved moving to the second stage of the study following the review of the safety and tolerability results from the first stage. The Phase 2 study evaluates 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). Vaxcyte expects to share topline data from the primary three-dose immunization series of the study by 2025, followed by topline data from the booster dose approximately nine months later.
Vaxcyte’s Phase 2 infant study is being conducted in two stages and compares VAX-24 to the broadest-spectrum standard-of-care PCVs currently available. Stage 1 of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels in a dose-escalation approach compared to VAXNEUVANCE (PCV15) in 48 infants. And the Stage 2 portion evaluates the safety, tolerability, and immunogenicity of VAX-24 at the same three dose levels compared to PCV20 in approximately 750 infants.
The participants from Stage 1 will continue the standard dosing regimen as part of Stage 2. The Company anticipates dosing new subjects in Stage 2 by the end of July. In agreement with the U.S. Food and Drug Administration (FDA), Vaxcyte amended the study protocol for Stage 2 and changed the study comparator to PCV20, which is currently the broadest-spectrum PCV recommended by the Advisory Committee on Immunization Practices (ACIP).
VAX-24 Phase 2 Infant Study: This Phase 2, randomized, observer-blind, dose-finding two-stage clinical study evaluates the safety, tolerability, and immunogenicity of VAX-24 in healthy infants. The Stage 1 portion of the study assessed the safety and tolerability of a single injection of VAX-24 at three dose levels (low dose/1.1mcg, middle dose/2.2mcg, mixed dose/2.2mcg or 4.4mcg) and compared to PCV15 in 48 infants in a dose-escalation approach. The Stage 2 portion evaluates the safety, tolerability, and immunogenicity of VAX-24 at the same three dose levels and compared to PCV20, currently the broadest-spectrum PCV recommended by the ACIP, in approximately 750 infants.
KEY QUOTES:
“Today’s news illustrates the steady momentum of our VAX-24 infant clinical program and underscores our commitment to progressing the evaluation of VAX-24 relative to the broadest-spectrum standard-of-care PCV available for this vulnerable population. We designed VAX-24 to deliver broader coverage and improved immune responses and we look forward to sharing topline data from the primary three-dose immunization series by 2025.”
— Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte
“The public health community has continued to affirm the need for broader-spectrum PCVs given the burden of disease in the pediatric population, and VAX-24 includes serotypes that cover a significant portion of IPD currently in circulation that are associated with high case-fatality rates, antibiotic resistance and meningitis. We believe the findings from our Phase 2 infant study will provide valuable insights into the potential utility of VAX-24, the broadest-spectrum PCV in U.S. clinics today.”
— Jim Wassil, Executive Vice President and Chief Operating Officer
