31-Valent Pneumococcal Conjugate Vaccine Launches Clinical Trial—Precision Vaccination News

Vaxcyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s adult Investigational New Drug (IND) application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate , designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte expects to initiate a Phase 1/2 clinical study of VAX-31 in 2023 and announce top-line results in the second half of 2024.

“FDA approval of the VAX-31 IND application represents an important step toward our goal of building a best-in-class PCV franchise that includes VAX-31 and VAX-24, a positive development in our 24-valent PCV space. Results from two adult Phase 2 clinical studies,” Vaxcyte CEO and co-founder Grant Pickering said in a press release on October 19, 2023.

“Given that VAX-31 will be the broadest-spectrum PCV to enter the clinic, leveraging the foundation already established with VAX-24, we are very excited about the prospects of this vaccine candidate.”

The VAX-31 Phase 1/2 clinical study is a randomized, observer-blinded, active-controlled, dose-finding clinical study designed to evaluate the safety, tolerability and efficacy of VAX-31 compared with Prevnar 20® (PCV20). Immunogenicity. Approximately 1,000 healthy adults aged 50 and older.

Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can cause IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis.

Pneumococcal pneumonia affects approximately 320,000 people in the United States each year, resulting in an estimated 150,000 hospitalizations and 5,000 deaths.More than 50% of cases of bacterial meningitis in the United States are also caused by pneumococci

As of October 20, 2023, a number of licensed pneumococcal vaccines and vaccine candidates are in clinical trials.