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Vaxcyte Completes Enrollment of OPUS-1 and OPUS-2 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults
OPUS-1 Phase 3 Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines (PCVs) Through Head-to-Head Safety, Tolerability and
About this update from Vaxcyte, Inc.
[{"type":"text","content":"OPUS-1 Phase 3 Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines (PCVs) Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive® (PCV21) and Prevnar 20® (PCV20), the Current Standard-of-Care PCVs Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Phase 3 Study Expected in Fourth Quarter of 2026 OPUS-2 Phase 3 Study Evaluating Concomitant Administration of VAX-31 and Seasonal Influenza Vaccine Designed to Provide Real-World Performance Insights in Adults; Results Expected in First Half of 2027 OPUS-3 Phase 3 Study Enrollment Ongoing in Adults Previously Vaccinated with Pneumococcal Vaccines; Results Expected in First Half of 2027 SAN CARLOS, Calif., March 23, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced the completion of enrollment in the VAX-31 OPUS-1 Phase 3 pivotal, noninferiority trial with approximately 4,000 participants and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine in approximately 1,300 participants. The Phase 3 program evaluating VAX-31, the Company’s next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate, for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults was finalized in consultation and alignment with the U.S. Food and Drug Administration (FDA) and is intended to generate a broad and robust dataset to support a planned Biologics License Application (BLA) submission. “Completing enrollment in the Phase 3 OPUS-1 and OPUS-2 trials represents two important milestones in the development of VAX-31 and reflects the disciplined execution of our comprehensive clinical program,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “With VAX-31, we are aiming to expand the breadth of disease and serotype coverage while ensuring immunogenicity levels remain high to support durable protection. Based on the strength of the unprecedented results from our VAX-31 Phase 1/2 study in adults and our carrier-sparing platform, we believe VAX-31 has the potential to set a new standard-of-care as a best-in-class, next-generation pneumococcal conjugate vaccine for both adults and children. We look forward to announcing topline data from the OPUS-1 trial i...