MSD’s CAPVAXIVE vaccine has demonstrated promising results from the STRIDE-8 Phase III trial, which showed positive immune responses in adults at increased risk for pneumococcal disease.
The double-blind, randomised, active comparator-controlled trial contained 518 participants.
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It assessed the safety, immunogenicity and tolerability of CAPVAXIVE compared to the PCV15 vaccine along with PPSV23 in vaccine-naive adults aged 18 to 64 with certain chronic conditions.
CAPVAXIVE was found to be immunogenic for all 21 serotypes included in the vaccine, with immune responses comparable or higher than PCV15 followed by PPSV23 for the 13 common serotypes.
The proportions of participants with adverse events were numerically lower in the CAPVAXIVE group compared to those who received PCV15 and PPSV23 in the trial. The results suggest that CAPVAXIVE could offer broader protection against pneumococcal disease.
Merck Scientific Advisory Committee member Dr Walter Orenstein said: “Adults with chronic medical conditions, such as kidney disease or diabetes, are particularly vulnerable to invasive pneumococcal disease (IPD), which may increase their risk of severe illness.
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By GlobalData“These data further demonstrate that the broad serotype coverage CAPVAXIVE provides can help prevent invasive disease among vulnerable adults.”
CAPVAXIVE received accelerated approval from the US Food and Drug Administration in June 2024 for active immunisation to prevent invasive disease and pneumonia caused by specific streptococcus pneumoniae serotypes in adults.
A modelling study suggested that the introduction of CAPVAXIVE could reduce the incidence of IPD by 33.9% over ten years in the US.
The vaccine is designed to protect against the majority of serotypes causing IPD, covering approximately 84% of cases in adults over 50 and 85% in those over 65, based on Centers for Disease Control and Prevention data.
The comprehensive Phase III programme for CAPVAXIVE includes multiple studies, with STRIDE-8 being part of a series that spans STRIDE-3 to STRIDE-10.
