Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine |
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Authors: | Lisa A. Jackson Alejandra Gurtman Kathryn Rice Karlis Pauksens Richard N. Greenberg Thomas R. Jones Daniel A. Scott Emilio A. Emini William C. Gruber Beate Schmoele-Thoma |
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Affiliation: | 1. The Group Health Research Institute, Group Health, Seattle, WA, USA;2. Vaccine Research, Pfizer Inc., Pearl River, New York, USA;3. VA Medical Center, Minneapolis, MN, USA;4. Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Akademiska sjukhuset, Uppsala, Sweden;5. University of Kentucky Medical Center, Lexington, KY, USA;6. Pfizer GmbH, Berlin, Germany |
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Abstract: | BackgroundThe currently recommended single dose of the 23-valent pneumococcal free polysaccharide vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent polysaccharide conjugate vaccine (PCV13).MethodsWe performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination.ResultsFollowing the enrollment vaccination, OPA titers were significantly greater in the PCV13 group compared to the PPSV23 group for 10 of the 12 serotypes common to both vaccines and to serotype 6A which is unique to PCV13. Responses were noninferior for the other 2 common serotypes. Responses to PCV13 given at 1 year were generally lower in the group that received PPSV23 at enrollment.ConclusionIn adults aged 70 years and older previously vaccinated with PPSV23, PCV13 was significantly more immunogenic than PPSV23 for most of the common serotypes and for serotype 6A. The OPA responses after a follow-on dose of PCV13 one year later indicate that a prior dose of PPSV23, but not PCV13, diminishes the response to the subsequent administration of PCV13. |
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Keywords: | ACIP, United States Advisory Committee on Immunization Practices AE, adverse event CI, confidence interval CRM197, cross-reactive material 197 GMR, geometric mean ratio GMT, geometric mean titer ITP, idiopathic thrombocytopenic purpura OPA, opsonophagocytic activity PCV, pneumococcal polysaccharide 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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