STRIDE-8 Study Results Highlight CAPVAXIVE’s Efficacy in Pneumococcal Disease Prevention
CAPVAXIVE Demonstrates Strong Immune Response and Coverage Against Major Serotypes
RAHWAY, N.J. — Merck (NYSE: MRK), known as MSD outside of the U.S. and Canada, presented promising results from the STRIDE-8 Phase 3 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) at IDWeek 2024 in Los Angeles. This latest study builds upon the established clinical profile of CAPVAXIVE, showcasing its ability to generate robust immune responses in adults.
CAPVAXIVE is designed to protect against serotypes responsible for approximately 84% of invasive pneumococcal disease (IPD) cases in adults aged 50 and older.
Study Overview
The STRIDE-8 trial assessed the immunogenicity, safety, and tolerability of CAPVAXIVE compared to PCV15 (pneumococcal 15-valent conjugate vaccine) in conjunction with PPSV23 (pneumococcal 23-valent polysaccharide vaccine) among vaccine-naïve adults aged 18-64 with specific chronic conditions that increase their risk for pneumococcal disease.
Key Findings from STRIDE-8:
- Immunogenicity: CAPVAXIVE showed strong immune responses across all 21 serotypes in the vaccine, measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) at Day 30.
- Comparative Response: The immune response from CAPVAXIVE was comparable to that of PCV15 followed by PPSV23 for the 13 common serotypes, and it exceeded responses for the eight serotypes unique to CAPVAXIVE.
- Safety Profile: Adverse events (AEs), including injection-site reactions and systemic AEs, were numerically lower in the CAPVAXIVE group than in the PCV15 + PPSV23 group.
Dr. Walter Orenstein, professor emeritus at Emory University and member of Merck’s Scientific Advisory Committee, emphasized the importance of these findings for adults with chronic medical conditions, stating, “The broad serotype coverage CAPVAXIVE provides can help prevent invasive disease among vulnerable adults.”
Indications and Safety Information
CAPVAXIVE is indicated for active immunization against invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes for individuals 18 years and older. Notably, the approval for pneumonia prevention is based on immune responses measured by OPA, with continued approval dependent on further confirmation of clinical benefits.
Safety Considerations: CAPVAXIVE should not be administered to individuals with a history of severe allergic reactions to any components of the vaccine. Common side effects reported in clinical trials include injection-site pain, fatigue, and headache.
Addressing Health Disparities
At IDWeek, Merck also discussed findings from a targeted literature review and a modeling study assessing the burden of pneumococcal disease among U.S. adults. The review highlighted significant disparities in disease burden and vaccination rates among Black adults and those in rural areas with lower socioeconomic status.
The modeling study projected that CAPVAXIVE could lead to a 33.9% reduction in IPD incidence over ten years, equating to approximately 14,000 fewer cases compared to PCV20.
About CAPVAXIVE
CAPVAXIVE is designed to address serotypes primarily responsible for adult IPD, including eight unique serotypes. Administered as a single dose, it aims to enhance protection against pneumococcal disease.
Merck’s Commitment: For over four decades, Merck has prioritized pneumococcal disease prevention through vaccination. The company remains dedicated to developing options that meet the needs of various populations, recognizing the different serotype risks faced by adults and children.
For more information about Merck’s pipeline and their commitment to health solutions, visit www.merck.com.
About Merck
Merck, known as MSD outside of the U.S. and Canada, leverages advanced science to improve lives globally. With a legacy of innovation, the company aims to be a leader in biopharmaceuticals, focusing on research that addresses critical health challenges across populations.
