Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)

Song JY; Chang CJ; Andrews C; Diez-Domingo J; Oh MD; Dagan R; Hartzel J; Pedley A; Li J; Sterling T; Tamms G; Chiarappa JA; Lutkiewicz J; Musey L; Tu Y; Buchwald UK; V114-016 (PNEU-PATH) study group

Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)

Background: Streptococcus pneumoniae causes pneumococcal disease, and older adults are at an increased risk. Sequential vaccination of 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for broad protection against pneum...

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Autores:	Song JY, Chang CJ, Andrews C, Diez-Domingo J, Oh MD, Dagan R, Hartzel J, Pedley A, Li J, Sterling T, Tamms G, Chiarappa JA, Lutkiewicz J, Musey L, Tu Y, Buchwald UK, V114-016 (PNEU-PATH) study group
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2021
País:	España
Institución:	Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:	r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:	oai:fisabio.fundanetsuite.com:p10718
Acceso en línea:	https://fisabio.portalinvestigacion.com/publicaciones/10718
Access Level:	acceso abierto
Palabra clave:	Pneumococcal conjugate vaccine Sequential vaccination Safety Immunogenicity Pneumococcal disease

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spelling	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)Song JYChang CJAndrews CDiez-Domingo JOh MDDagan RHartzel JPedley ALi JSterling TTamms GChiarappa JALutkiewicz JMusey LTu YBuchwald UKV114-016 (PNEU-PATH) study groupPneumococcal conjugate vaccineSequential vaccinationSafetyImmunogenicityPneumococcal diseaseBackground: Streptococcus pneumoniae causes pneumococcal disease, and older adults are at an increased risk. Sequential vaccination of 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for broad protection against pneumococcal disease in some countries. Methods: This phase III trial evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 12 months later by PPSV23, in healthy adults aged >50 years (NCT03480763). A total of 652 participants were randomized 1:1 to receive either V114 or PCV13, followed by PPSV23. Results: The most common solicited adverse events (AEs) following PCV vaccination included injection-site pain and fatigue. Higher proportions of participants with these events were observed in the V114 group following PCV; however, these differences were not clinically significant. Following PPSV23 vaccination, the most common solicited AEs were injection-site pain and injection-site swelling; the proportions of participants with these events were comparable between both groups. Incidence of serious AEs was low in both groups following PCV and PPSV23, and none were related to study vaccines. No deaths occurred during the study. Serum opsonophagocytic activity geometric mean titers and immunoglobulin G geometric mean concentrations were comparable between both groups for all 15 serotypes in V114 following PPSV23. Immune responses elicited by V114 persisted for at least 12 months. Immune responses at 30 days and 12 months post-vaccination with PCV were comparable between both groups for the 13 shared serotypes and higher in the V114 group for the V114-unique serotypes (22F and 33F). Conclusion: Administration of V114 followed by PPSV23 was well tolerated and induced comparable antibody levels to PCV13 followed by PPSV23 in healthy adults aged >50 years. (c) 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Elsevier BV2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/10718VaccineISSN: 13588745ISSNe: 0264410Xreponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p107182026-06-11T12:45:17Z
dc.title.none.fl_str_mv	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)
title	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)
spellingShingle	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH) Song JY Pneumococcal conjugate vaccine Sequential vaccination Safety Immunogenicity Pneumococcal disease
title_short	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)
title_full	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)
title_fullStr	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)
title_full_unstemmed	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)
title_sort	Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)
dc.creator.none.fl_str_mv	Song JY Chang CJ Andrews C Diez-Domingo J Oh MD Dagan R Hartzel J Pedley A Li J Sterling T Tamms G Chiarappa JA Lutkiewicz J Musey L Tu Y Buchwald UK V114-016 (PNEU-PATH) study group
author	Song JY
author_facet	Song JY Chang CJ Andrews C Diez-Domingo J Oh MD Dagan R Hartzel J Pedley A Li J Sterling T Tamms G Chiarappa JA Lutkiewicz J Musey L Tu Y Buchwald UK V114-016 (PNEU-PATH) study group
author_role	author
author2	Chang CJ Andrews C Diez-Domingo J Oh MD Dagan R Hartzel J Pedley A Li J Sterling T Tamms G Chiarappa JA Lutkiewicz J Musey L Tu Y Buchwald UK V114-016 (PNEU-PATH) study group
author2_role	author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Pneumococcal conjugate vaccine Sequential vaccination Safety Immunogenicity Pneumococcal disease
topic	Pneumococcal conjugate vaccine Sequential vaccination Safety Immunogenicity Pneumococcal disease
description	Background: Streptococcus pneumoniae causes pneumococcal disease, and older adults are at an increased risk. Sequential vaccination of 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for broad protection against pneumococcal disease in some countries. Methods: This phase III trial evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 12 months later by PPSV23, in healthy adults aged >50 years (NCT03480763). A total of 652 participants were randomized 1:1 to receive either V114 or PCV13, followed by PPSV23. Results: The most common solicited adverse events (AEs) following PCV vaccination included injection-site pain and fatigue. Higher proportions of participants with these events were observed in the V114 group following PCV; however, these differences were not clinically significant. Following PPSV23 vaccination, the most common solicited AEs were injection-site pain and injection-site swelling; the proportions of participants with these events were comparable between both groups. Incidence of serious AEs was low in both groups following PCV and PPSV23, and none were related to study vaccines. No deaths occurred during the study. Serum opsonophagocytic activity geometric mean titers and immunoglobulin G geometric mean concentrations were comparable between both groups for all 15 serotypes in V114 following PPSV23. Immune responses elicited by V114 persisted for at least 12 months. Immune responses at 30 days and 12 months post-vaccination with PCV were comparable between both groups for the 13 shared serotypes and higher in the V114 group for the V114-unique serotypes (22F and 33F). Conclusion: Administration of V114 followed by PPSV23 was well tolerated and induced comparable antibody levels to PCV13 followed by PPSV23 in healthy adults aged >50 years. (c) 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
publishDate	2021
dc.date.none.fl_str_mv	2021
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://fisabio.portalinvestigacion.com/publicaciones/10718
url	https://fisabio.portalinvestigacion.com/publicaciones/10718
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Elsevier BV
publisher.none.fl_str_mv	Elsevier BV
dc.source.none.fl_str_mv	Vaccine ISSN: 13588745 ISSNe: 0264410X reponame:r-FISABIO. Repositorio Institucional de Producción Científica instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str	Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str	r-FISABIO. Repositorio Institucional de Producción Científica
collection	r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)

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