Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age

Susan J. Ermlich; Charles P. Andrews; Steven Folkerth; Richard Rupp; David Greenberg; Richard D. McFetridge; Jonathan Hartzel; Rocio D. Marchese; Jon E. Stek; Chitrananda Abeygunawardana; Luwy K. Musey

doi:10.1016/j.vaccine.2018.03.012

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age

Susan J. Ermlich, Charles P. Andrews, Steven Folkerth, Richard Rupp, David Greenberg, Richard D. McFetridge, Jonathan Hartzel, Rocio D. Marchese, Jon E. Stek, Chitrananda Abeygunawardana, Luwy K. Musey

Research output: Contribution to journal › Article › peer-review

32 Scopus citations

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.

Original language	English
Pages (from-to)	6875-6882
Number of pages	8
Journal	Vaccine
Volume	36
Issue number	45
DOIs	https://doi.org/10.1016/j.vaccine.2018.03.012
State	Published - 29 Oct 2018
Externally published	Yes

Keywords

Immunogenicity
Pneumococcal conjugate vaccine
Safety

ASJC Scopus subject areas

Molecular Medicine
Immunology and Microbiology (all)
Veterinary (all)
Public Health, Environmental and Occupational Health
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.vaccine.2018.03.012

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Ermlich, S. J., Andrews, C. P., Folkerth, S., Rupp, R., Greenberg, D., McFetridge, R. D., Hartzel, J., Marchese, R. D., Stek, J. E., Abeygunawardana, C., & Musey, L. K. (2018). Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. Vaccine, 36(45), 6875-6882. https://doi.org/10.1016/j.vaccine.2018.03.012

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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",

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doi = "10.1016/j.vaccine.2018.03.012",

language = "English",

volume = "36",

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TY - JOUR

T1 - Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age

AU - Ermlich, Susan J.

AU - Andrews, Charles P.

AU - Folkerth, Steven

AU - Rupp, Richard

AU - Greenberg, David

AU - McFetridge, Richard D.

AU - Hartzel, Jonathan

AU - Marchese, Rocio D.

AU - Stek, Jon E.

AU - Abeygunawardana, Chitrananda

AU - Musey, Luwy K.

N1 - 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: © 2017 Elsevier Ltd

PY - 2018/10/29

Y1 - 2018/10/29

N2 - 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.

AB - 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.

KW - Immunogenicity

KW - Pneumococcal conjugate vaccine

KW - Safety

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U2 - 10.1016/j.vaccine.2018.03.012

DO - 10.1016/j.vaccine.2018.03.012

M3 - Article

C2 - 29559167

AN - SCOPUS:85043990075

SN - 0264-410X

VL - 36

SP - 6875

EP - 6882

JO - Vaccine

JF - Vaccine

IS - 45

ER -

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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