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 journalArticle

6 Citations (Scopus)

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 languageEnglish (US)
JournalVaccine
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Conjugate Vaccines
Pneumococcal Vaccines
serotypes
immune response
vaccines
Safety
Immunoglobulin G
Vaccines
Serogroup
Health Priorities
antibodies
Antibodies
public health
Vaccination
polysaccharides
Public Health
vaccination

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

Cite this

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. / Ermlich, Susan J.; Andrews, Charles P.; Folkerth, Steven; Rupp, Richard; Greenberg, David; McFetridge, Richard D.; Hartzel, Jonathan; Marchese, Rocio D.; Stek, Jon E.; Abeygunawardana, Chitrananda; Musey, Luwy K.

In: Vaccine, 01.01.2018.

Research output: Contribution to journalArticle

Ermlich, SJ, Andrews, CP, Folkerth, S, Rupp, R, Greenberg, D, McFetridge, RD, Hartzel, J, Marchese, RD, Stek, JE, Abeygunawardana, C & Musey, LK 2018, 'Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age', Vaccine. https://doi.org/10.1016/j.vaccine.2018.03.012
Ermlich, Susan J. ; Andrews, Charles P. ; Folkerth, Steven ; Rupp, Richard ; Greenberg, David ; McFetridge, Richard D. ; Hartzel, Jonathan ; Marchese, Rocio D. ; Stek, Jon E. ; Abeygunawardana, Chitrananda ; Musey, Luwy K. / Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. In: Vaccine. 2018.
@article{fbc6cbab8699449d8ad4257c05786b8c,
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.}",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.vaccine.2018.03.012",
language = "English (US)",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",

}

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.

PY - 2018/1/1

Y1 - 2018/1/1

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

UR - http://www.scopus.com/inward/record.url?scp=85043990075&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85043990075&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2018.03.012

DO - 10.1016/j.vaccine.2018.03.012

M3 - Article

JO - Vaccine

JF - Vaccine

SN - 0264-410X

ER -