The US Food and Drug Administration (FDA) has cleared Vaxcyte’s infant Investigational New Drug (IND) application for VAX-24, its 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).
The company plans to initiate the infant Phase II study in the second quarter of 2023, with topline safety, tolerability and immunogenicity data following the primary three-dose immunisation series expected by 2025.
The FDA decision is based on the positive topline results from the VAX-24 Phase I/II proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age.
Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under. The burden of disease in the pediatric population underscores the need for a broader-spectrum vaccine.
Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte, said, “The 24 serotypes included in VAX-24 cover a significant portion of the IPD currently in circulation that are associated with high case-fatality rates, antibiotic resistance and meningitis.
“Importantly, the nine incremental serotypes in VAX-24 cover an additional 20-25% of strains causing IPD over the current 15-valent standard-of-care PCV in infants. Given the significant burden of disease in young children, there remains a need for broader-spectrum vaccines like VAX-24 and VAX-31, our 31-valent PCV candidate, that are designed to provide greater protection.”