Immunogenicity and safety of co-administration of adjuvanted respiratory syncytial virus prefusion F protein vaccine with 20-valent pneumococcal conjugate vaccine in adults aged ≥60 years: a randomized, non-inferiority trial.

Abstract

Respiratory syncytial virus (RSV) illness and pneumococcal disease present high disease burden and health risks to older adults. Vaccination against these two illnesses is a key strategy to reduce this burden, and co-administration of the two vaccines could enhance vaccine uptake. This study evaluated the immunogenicity, safety and reactogenicity of co-administration of adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) with 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged ≥60 years. This phase III, open-label, randomized, non-inferiority trial was conducted across 38 centers in Belgium, Poland, Spain and the United States. Participants (N=1112) were randomized 1:1 to receive adjuvanted RSVPreF3 vaccine and PCV20 vaccine either concomitantly (Co-Ad group) or one month apart (Control group). The primary objectives were to assess immunogenicity as measured by RSV-A and RSV-B neutralizing titers, and opsonophagocytic titers for the PCV20 serotypes. Safety and reactogenicity were assessed as secondary objectives. All primary immunogenicity objectives were met. The upper limit of the 95% confidence interval of the geometric mean titer ratios for RSV-A, RSV-B and all twenty PCV20 serotypes were within the pre-defined non-inferiority margins. Safety profiles were similar across both groups, with most adverse events being mild to moderate in severity and of short duration. Serious adverse events and potential immune-mediated diseases were rare and unrelated to vaccination. Co-administration of adjuvanted RSVPreF3 vaccine and PCV20 vaccine in older adults is immunologically non-inferior to their sequential administration, with an acceptable safety profile. These findings support co-administration as a strategy to enhance vaccine uptake.