Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults

Abstract

Background: Streptococcus pneumoniae is a major cause of morbidity and mortality among adults 50 years of age and older in the United States. Pneumococcal conjugate vaccines are efficacious against pneumococcal disease in children and may also offer advantages in adults.

Methods: We performed a randomized, modified double-blind trial that compared a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in 831 pneumococcal vaccine naive adults 60-64 years of age. An additional group of 403 adults 50-59 years of age received open-label PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured at baseline, and at 1 month and 1 year after vaccination.

Results: In the randomized trial, the month 1 post-vaccination OPA geometric mean titers in the PCV13 group were statistically significantly higher than in the PPSV23 group for 8 of the 12 serotypes common to both vaccines and for serotype 6A, a serotype unique to PCV13, and were comparable for the other 4 common serotypes. The immune response to PCV13 was generally greater in adults 50-59 years of age compared to adults 60-64 years of age. OPA titers declined from 1 month to 1 year after PCV13 administration but remained higher than pre-vaccination baseline titers.

Conclusions: PCV13 induces a greater functional immune response than PPSV23 for the majority of serotypes covered by PCV13, suggesting that PCV13 could offer immunological advantages over PPSV23 for prevention of vaccine-type pneumococcal infection.

Keywords: 13-valent pneumococcal conjugate vaccine; 23-valent polysaccharide vaccine; 7-valent pneumococcal conjugate vaccine; AE; Adult; CI; CRM197; GMR; GMT; IPD; LLOQ; LOD; OPA; PCV; PCV13; PCV7; PPSV23; Pneumococcal conjugate vaccine; Pneumonia; RCDC; SAE; adverse event; confidence interval; cross-reactive material 197; geometric mean ratio; geometric mean titer; invasive pneumococcal disease; limit of detection; lower limit of quantitation; opsonophagocytic activity; pneumococcal polysaccharide conjugate vaccine; reverse cumulative distribution curve; serious adverse event.