@article{34af660e305d4c3180bac8b2661fe48e,
title = "Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-na{\"i}ve adults ≥50 years of age",
abstract = "Background: Pneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) was evaluated in adults ≥50 years old (NCT01513551). Methods: 691 adults received one dose of PCV15, PCV13, or 23-valent pneumococcal polysaccharide vaccine (PPV23) and were followed 14 days for safety. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 1-month postvaccination. Results: Safety profiles were comparable across vaccination groups. PCV15 induced comparable levels of IgG GMCs and OPA GMTs to PCV13 and PPV23 for shared serotypes. Serotype-specific antibodies were numerically higher among recipients of PCV15 than PCV13 and PPV23 for 7 and 12 shared serotypes, respectively; and lower for 4 and 1 serotype(s), respectively. PCV15 induced higher IgG and OPA antibodies than PCV13 or PPV23 for serotypes unique to PCV15 (22F and 33F not in PCV13; 6A not in PPV23). Conclusions: PCV15 displayed an acceptable safety profile and induced IgG and OPA to all 15 serotypes included in the vaccine, at levels comparable to PCV13 and PPV23 for shared serotypes with these vaccines. Study identification: V114-002. CLINICALTRIALS.GOV identifier: NCT01513551.",
keywords = "Immunogenicity, Pneumococcal conjugate vaccine, Safety",
author = "Ermlich, {Susan J.} and Andrews, {Charles P.} and Steven Folkerth and Richard Rupp and David Greenberg and McFetridge, {Richard D.} and Jonathan Hartzel and Marchese, {Rocio D.} and Stek, {Jon E.} and Chitrananda Abeygunawardana and Musey, {Luwy K.}",
note = "Funding Information: Funding for this research was provided by Merck & Co., Inc., Kenilworth, NJ, USA (sponsor). Although the sponsor formally reviewed a penultimate draft, the opinions expressed are those of the authors and may not necessarily reflect those of the sponsor. All co-authors approved the final version of the manuscript. No author was paid for their work on this manuscript. CPA, SF, RR, and DG were investigators for the sponsor supported by research grants. SJE, RDM, JH, RDM, JES, CA, and LKM are employees of the sponsors and may hold stock and/or stock options from the sponsors. CPA, SF, RR, and DG: enrollment of subjects and/or data collection, review of the manuscript. SJE, JH, RDM, and JES: analysis and interpretation of data, and preparation of manuscript. RDM, CA, and LKM: study concept and design, analysis and interpretation of data, and preparation of manuscript. Funding Information: Funding for this research was provided by Merck & Co., Inc., Kenilworth, NJ, USA (sponsor). Although the sponsor formally reviewed a penultimate draft, the opinions expressed are those of the authors and may not necessarily reflect those of the sponsor. All co-authors approved the final version of the manuscript. Publisher Copyright: {\textcopyright} 2017 Elsevier Ltd",
year = "2018",
month = oct,
day = "29",
doi = "10.1016/j.vaccine.2018.03.012",
language = "English",
volume = "36",
pages = "6875--6882",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "45",
}
