Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Background: Pneumococcal disease remains a public health priority in adults. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine within three years following receipt of PPV23 was associated with increased reactogenicity and red...
Main Authors: | , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Taylor & Francis Group
2019-03-01
|
Series: | Human Vaccines & Immunotherapeutics |
Subjects: | |
Online Access: | http://dx.doi.org/10.1080/21645515.2018.1532250 |
_version_ | 1797677397486600192 |
---|---|
author | James T. Peterson Helen L. Stacey John E. MacNair Jianing Li Jonathan S. Hartzel Tina M. Sterling Patrice Benner Gretchen M. Tamms Luwy K. Musey |
author_facet | James T. Peterson Helen L. Stacey John E. MacNair Jianing Li Jonathan S. Hartzel Tina M. Sterling Patrice Benner Gretchen M. Tamms Luwy K. Musey |
author_sort | James T. Peterson |
collection | DOAJ |
description | Background: Pneumococcal disease remains a public health priority in adults. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine within three years following receipt of PPV23 was associated with increased reactogenicity and reduced antibody titers in comparison to longer intervals. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) was evaluated in adults ≥ 65 years of age with prior history of PPV23 vaccination (V114-007; NCT02573181). Methods: A total of 250 adults who received PPV23 at least 1 year prior to study entry received a single dose of either PCV15 or PCV13 (125/arm) and were followed for safety for 14 days postvaccination. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 30 days postvaccination. Results: Safety profiles were comparable between PCV15 and PCV13 recipients. Following vaccination, serotype-specific antibody responses for the 13 shared serotypes were generally comparable between recipients of PCV15 and PCV13 for IgG GMCs, OPA GMTs, and geometric mean fold rises (GMFRs) and percentages of subjects with ≥ 4-fold-rise from baseline for both IgG and OPA. Recipients of PCV15 had numerically higher antibody responses than PCV13 for two serotypes unique to PCV15 (22F, 33F). Conclusion: PCV15 was generally well tolerated and induced high levels of IgG and OPA antibodies to all 15 serotypes included in the vaccine when given as a single dose to adults ≥ 65 years of age previously vaccinated with PPV23. |
first_indexed | 2024-03-11T22:44:37Z |
format | Article |
id | doaj.art-3b328c23fcc848fa93e938fb462d2280 |
institution | Directory Open Access Journal |
issn | 2164-5515 2164-554X |
language | English |
last_indexed | 2024-03-11T22:44:37Z |
publishDate | 2019-03-01 |
publisher | Taylor & Francis Group |
record_format | Article |
series | Human Vaccines & Immunotherapeutics |
spelling | doaj.art-3b328c23fcc848fa93e938fb462d22802023-09-22T08:38:24ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2019-03-0115354054810.1080/21645515.2018.15322501532250Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccineJames T. Peterson0Helen L. Stacey1John E. MacNair2Jianing Li3Jonathan S. Hartzel4Tina M. Sterling5Patrice Benner6Gretchen M. Tamms7Luwy K. Musey8Foothill Family ClinicDiablo Clinical ResearchMerck & Co., Inc., Merck Research LaboratoriesMerck & Co., Inc., Merck Research LaboratoriesMerck & Co., Inc., Merck Research LaboratoriesMerck & Co., Inc., Merck Research LaboratoriesMerck & Co., Inc., Merck Research LaboratoriesMerck & Co., Inc., Merck Research LaboratoriesMerck & Co., Inc., Merck Research LaboratoriesBackground: Pneumococcal disease remains a public health priority in adults. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine within three years following receipt of PPV23 was associated with increased reactogenicity and reduced antibody titers in comparison to longer intervals. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) was evaluated in adults ≥ 65 years of age with prior history of PPV23 vaccination (V114-007; NCT02573181). Methods: A total of 250 adults who received PPV23 at least 1 year prior to study entry received a single dose of either PCV15 or PCV13 (125/arm) and were followed for safety for 14 days postvaccination. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 30 days postvaccination. Results: Safety profiles were comparable between PCV15 and PCV13 recipients. Following vaccination, serotype-specific antibody responses for the 13 shared serotypes were generally comparable between recipients of PCV15 and PCV13 for IgG GMCs, OPA GMTs, and geometric mean fold rises (GMFRs) and percentages of subjects with ≥ 4-fold-rise from baseline for both IgG and OPA. Recipients of PCV15 had numerically higher antibody responses than PCV13 for two serotypes unique to PCV15 (22F, 33F). Conclusion: PCV15 was generally well tolerated and induced high levels of IgG and OPA antibodies to all 15 serotypes included in the vaccine when given as a single dose to adults ≥ 65 years of age previously vaccinated with PPV23.http://dx.doi.org/10.1080/21645515.2018.1532250pneumococcal conjugate vaccinesafetyimmunogenicity |
spellingShingle | James T. Peterson Helen L. Stacey John E. MacNair Jianing Li Jonathan S. Hartzel Tina M. Sterling Patrice Benner Gretchen M. Tamms Luwy K. Musey Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine Human Vaccines & Immunotherapeutics pneumococcal conjugate vaccine safety immunogenicity |
title | Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine |
title_full | Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine |
title_fullStr | Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine |
title_full_unstemmed | Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine |
title_short | Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine |
title_sort | safety and immunogenicity of 15 valent pneumococcal conjugate vaccine compared to 13 valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23 valent pneumococcal polysaccharide vaccine |
topic | pneumococcal conjugate vaccine safety immunogenicity |
url | http://dx.doi.org/10.1080/21645515.2018.1532250 |
work_keys_str_mv | AT jamestpeterson safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT helenlstacey safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT johnemacnair safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT jianingli safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT jonathanshartzel safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT tinamsterling safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT patricebenner safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT gretchenmtamms safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine AT luwykmusey safetyandimmunogenicityof15valentpneumococcalconjugatevaccinecomparedto13valentpneumococcalconjugatevaccineinadults65yearsofagepreviouslyvaccinatedwith23valentpneumococcalpolysaccharidevaccine |