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Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults
Authors:Lisa A Jackson  Alejandra Gurtman  Martin van Cleeff  Kathrin U Jansen  Deepthi Jayawardene  Carmel Devlin  Daniel A Scott  Emilio A Emini  William C Gruber  Beate Schmoele-Thoma
Institution:1. Group Health Research Institute, Seattle, Washington, United States;2. Vaccine Research Pfizer Inc, Pearl River, New York, United States;3. Triangle Medical Research Associates, Cary, North Carolina, United States;4. Pfizer GmbH, Berlin, Germany
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:AE  adverse event  CI  confidence interval  CRM197  cross-reactive material 197  GMR  geometric mean ratio  GMT  geometric mean titer  IPD  invasive pneumococcal disease  LLOQ  lower limit of quantitation  LOD  limit of detection  OPA  opsonophagocytic activity  PCV  pneumococcal polysaccharide conjugate vaccine  PCV7  7-valent pneumococcal conjugate vaccine  PCV13  13-valent pneumococcal conjugate vaccine  PPSV23  23-valent polysaccharide vaccine  RCDC  reverse cumulative distribution curve  SAE  serious adverse event
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