Merck, known as MSD outside the US and Canada, announced new positive results from a late-stage trial of Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) in adults with certain chronic conditions.
Capvaxive (V116) is an approved 21-valent pneumococcal conjugate vaccine. It is indicated for active immunisation to prevent invasive disease and pneumonia in adults aged 18 and older.
In June this year, the US Food and Drug Administration (FDA) approved the vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in individuals 18 years of age and older.
The STRIDE-8 Phase 3 trial evaluated the immunogenicity, safety, and tolerability of Capvaxive.
The study compared this vaccine to PCV15 (pneumococcal 15-valent conjugate vaccine) in combination with PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in vaccine-naïve adults aged 18-64 with specific chronic conditions. These conditions increase the risk of pneumococcal disease.
Key findings from the STRIDE-8 trial highlight the effectiveness of Capvaxive. The vaccine showed strong immunogenicity for all 21 strains included in the vaccine at Day 30.
Immune responses from the vaccines were comparable to those of PCV15 followed by PPSV23 for the 13 common serotypes. The response was found higher for the eight serotypes unique to V116.
Additionally, the rates of adverse events, including injection-site and systemic reactions, were lower in the V116 + placebo group compared to the PCV15 + PPSV23 group.
Merck Research Laboratories vaccines clinical research therapeutic area head Macaya Douoguih said: “The data presented during IDWeek build on the robust clinical profile of Capvaxive and illustrate the importance of improving equitable access for those at high risk for invasive pneumococcal disease.
“Our commitment to prioritising research and advancements that benefit populations at highest risk of invasive pneumococcal disease remains critical.”
Merck also shared data from a modelling study assessing the health impact of introducing Capvaxive in US adults.
The study found that using the vaccine could reduce invasive pneumococcal disease (IPD) incidence by 33.9% over ten years, alongside continued paediatric PCV vaccination.
