FDA clears investigational NDA for VAX-31 to prevent invasive pneumococcal disease

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The initiation of a phase 2 study of the investigational 31-valent pneumococcal conjugate vaccine is expected by the end of January 2025.

FDA clears investigational NDA for VAX-31 to prevent invasive pneumococcal disease | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

FDA clears investigational NDA for VAX-31 to prevent invasive pneumococcal disease | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

VAX-31 (Vaxcyte), an infant and adult investigational 31-valent pneumococcal conjugate vaccine (PCV) candidate to prevent invasive pneumococcal disease (IPD), has received infant Investigational New Drug (IND) application clearance from the FDA according to an announcement from Vaxcyte.1

The potential broad-spectrum PCV candidate is being studied to prevent IPD in both the pediatric and adult populations, and is designed to cover approximately 94% of IPD in US children under 5 years of age. With this acceptance, Vaxcyte plans to initiate a phase 2 VAX-31 infant study—a randomized, double-blind, active-controlled, dose-finding trial—by the end of January 2025.1

The study, according to Vaxcyte, will include a primary immunization series made up of 3 doses at 2, 4, and 6 months of age, respectively, followed by a subsequent booster at 12 to 15 months of age. The vaccine company expects topline safety, tolerability, and immunogenicity data from the study to be available in mid-2026, with topline data from the booster dose to follow approximately 9 months later.1

Clearance of the IND for the pediatric population was supported by safety, tolerability, and immunogenicity data from the VAX-31 phase 1/2 study in adults. VAX-31 has potential to provide protection against currently circulating and historically prevalent serotypes. VAX-31 was designed to cover approximately 86% of acute otitis media in children under the age of 5 years in the United States.1

Results from the phase 1/2 adult study was announced on September 3, 2024, in which data from 1015 healthy adults aged 50 years and older were included. The vaccine candidate was well tolerated and demonstrated a safety profile at all doses studied through the 6-month evaluation period. "At the middle and high doses, VAX-31 met or exceeded the OPA response non-inferiority criteria(1) for all 20 serotypes common with PCV20," stated Vaxcyte in a September announcement of the phase 1/2 adult data.2

Approximately 300,000 children younger than 5 years of age die each year across the globe because of Streptococcus pneumoniae, the leading cause of vaccine-preventable fatalities in this age group, per Vaxcyte.1

According to the Centers for Disease Control and Prevention, vaccination is recommended for all children younger than 5 years of age, and those aged 5 to 18 years with risk conditions.3

"We are incredibly proud of the significant progress we continue to make with VAX-31, underscored by the clearance of the infant IND application and receipt of the Breakthrough Therapy designation for adults,” Jim Wassil, executive vice president, CEO, Vaxcyte, said in a statement. "The body of positive evidence generated by the VAX-31 and VAX-24 adult studies validates the potential of our site-specific, carrier-sparing platform to deliver best-in-class, broad-spectrum PCVs designed to provide protection against both currently circulating and historically prevalent serotypes while raising the bar for immunogenicity."1

References:

1. Vaxcyte provides positive regulatory updates on VAX-31 pediatric and adult programs. Vaxcyte Inc. Press release. November 12, 2024. Accessed November 12, 2024. https://investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-provides-positive-regulatory-updates-vax-31-pediatric

2. Vaxcyte Reports Positive Topline Data from Phase 1/2 Study of VAX-31, its 31-Valent Pneumococcal Conjugate Vaccine Candidate, in Adults Aged 50 and Older. Press release. September 3, 2024. Accessed November 12, 2024. https://investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-reports-positive-topline-data-phase-12-study-vax-31-its

3. Pneumococcal vaccination. CDC. Updated October 26, 2024. https://www.cdc.gov/pneumococcal/vaccines/index.html

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