Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18-49 years of age, naive to 23-valent pneumococcal polysaccharide vaccine.

摘要: Abstract Background Based on the success of vaccination with pneumococcal conjugate vaccines (PCVs) in children, recent studies have focused PCVs adults. Data from a randomized, double-blind study comparing immunogenicity, tolerability, and safety 13-valent PCV (PCV13) 23-valent polysaccharide vaccine (PPSV23) PPSV23-naive adults 60–64 years age been published. The same also included cohort aged 18–49 that received open-label PCV13. purpose this was to examine safety, tolerability PCV13 adult subjects compared for whom is approved. Methods Adults naive PPSV23 were grouped by into 2 cohorts: (n = 899; further stratified 3 subgroups 18–29, 30–39, 40–49 years) (n = 417). All 1 dose In both groups, immunogenicity assessed antipneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) IgG concentrations (GMCs) month after vaccination. Safety evaluated. Results years, OPA GMTs GMCs noninferior all 13 serotypes statistically significantly higher except serotype (OPA GMT) 5 (IgG GMCs) years. Immune responses highest youngest subgroup (18–29 years). Local reactions systemic events more common self-limited. Conclusion are robust ≥18 age, observed subgroup. its immunologic profile, may serve an important therapeutic role younger adults, particularly those underlying medical conditions who increased risk serious infections.