930 Safety, Tolerability and Immunogenicity of 15-Valent Pneumococcal Conjugate Vaccine + ppv23 12 months Later in Healthy Adults ≥ 50

Abstract

Background Older adults are at increased risk of pneumococcal disease (PD). V114, an investigational 15-valent Pneumococcal Conjugate Vaccine (PCV), contains all serotypes in 13-valent PCV (PCV13) plus serotypes 22F and 33F. This phase 3 trial evaluated the safety, tolerability and immunogenicity of V114 or PCV13 followed 12 months later by PPSV23 in healthy adults aged ≥50 years. Materials/Method 652 eligible adults were randomised 1:1 to receive V114 or PCV13 followed by PPSV23 12 months later. Solicited and non-solicited adverse events (AEs) were collected after each vaccination. Serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were measured at Day 1, Day 30, Month 12 and Month 13. Results The most common solicited AEs following PCV were injection-site pain, fatigue and myalgia; higher proportions of participants with solicited AEs were observed in the V114 group; however, the differences were not clinically significant, as most AEs were mild and of short duration. The most common solicited AEs following PPSV23 were injection-site pain, injection-site swelling, fatigue and myalgia; these events were comparable across both intervention groups. The proportion of participants with serious AEs were low in both groups and none reported to be vaccine related. No deaths occurred during the study. Serotype-specific OPA geometric mean titres (GMTs) and IgG geometric mean concentrations (GMCs) were comparable between the groups for all 15 serotypes 30 days post-vaccination with PPSV23. OPA GMTs and IgG GMCs were comparable between PCV groups for the 13 shared serotypes and higher in V114 than PCV13 for serotypes 22F and 33F 30 days and 12 months post-vaccination with PCV. V114 elicited an immune response that persisted for at least 12 months. Conclusion Sequential administration of V114 and PPSV23 is well tolerated, immunogenic and generally comparable to PCV13 followed by PPSV23 in healthy adults ≥50 years of age.