Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults

Díez-Domingo, Javier; Tinoco, Juan Carlos; Poderc, Airi; Dinleyicid, Ener Cagri; Nelle, Haylene; Cueva, Ignacio Salamanca de la; Inceg, Tolga; Moreira Junior, Edson Duarte; Ahmedi, Khatija; Luzj, Kleber; Kovshirinak, Yulia; Pechl, Carlos Eduardo Medina; Akhundm, Tauseefullah; Romolinin, Valerio; Costantini, Marco; Mzoloo, Thembile; Kunnelp, Barry; Lechevinq, Isabelle; Aggravir, Marianna; Tiberis, Paola; Narendrant, K.; Martínez, Juan Antonio García; Basile, Venere; Fragapanem, Elena; Lattanzi, Maria; Pellegrini, Michele

Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults

Detalhes bibliográficos
Autor(a) principal:	Díez-Domingo, Javier
Data de Publicação:	2021
Outros Autores:	Tinoco, Juan Carlos, Poderc, Airi, Dinleyicid, Ener Cagri, Nelle, Haylene, Cueva, Ignacio Salamanca de la, Inceg, Tolga, Moreira Junior, Edson Duarte, Ahmedi, Khatija, Luzj, Kleber, Kovshirinak, Yulia, Pechl, Carlos Eduardo Medina, Akhundm, Tauseefullah, Romolinin, Valerio, Costantini, Marco, Mzoloo, Thembile, Kunnelp, Barry, Lechevinq, Isabelle, Aggravir, Marianna, Tiberis, Paola, Narendrant, K., Martínez, Juan Antonio García, Basile, Venere, Fragapanem, Elena, Lattanzi, Maria, Pellegrini, Michele
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/49992
Resumo:	MOREIRA JUNIOR, Edson Duarte. Fundação Oswalado Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. aVaccine Research Area, FISABIO-Public Health, Valencia, Spain; bInfectious Disease, Hospital General de Durango, Durango, Mexico; cKliiniliste Uuringute Keskus, Tartu, Estonia; dPediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey; eTiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa; fInstituto Hispalense de Pediatria, Seville, Spain; gFaculty of Medicine, Dokuz Eylul University, Izmir, Turkey; hAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil; iSetshaba Research Centre, Tshwane, and Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa; jCentro de Pesquisas Clinicas de Natal, Rio Grande do Norta, Brazil; kInfectious Diseases and Epidemiology, Siberian State Medical University, Tomsk, Russian Federation; lMedical Care and Research SA de CV, Mérida, Mexico; mClinical Research and Development Centre, GSK, Siena, Italy; nBiostatistics, GSK, Siena, Italy; oBiostatistics, GSK, Amsterdam, The Netherlands; pData Strategy & Management, Global Clinical Operations Development – R&D, GSK, Amsterdam, The Netherlands; qClinical Laboratory Sciences, GSK, Rixensart, Belgium; rTechnical Development, GSK, Siena, Italy; sSafety Evaluation and Risk Management, GSK, Siena, Italy; tGlobal Clinical Operations, GSK, Bangalore, India; uMedical Department, GSK, Madrid, Spain; vGlobal Clinical Delivery, Global Clinical Operations Development, GSK, Siena, Italy

Metadados do item

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oai_identifier_str	oai:www.arca.fiocruz.br:icict/49992
network_acronym_str	CRUZ
network_name_str	Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str	2135
spelling	Díez-Domingo, JavierTinoco, Juan CarlosPoderc, AiriDinleyicid, Ener CagriNelle, HayleneCueva, Ignacio Salamanca de laInceg, TolgaMoreira Junior, Edson DuarteAhmedi, KhatijaLuzj, KleberKovshirinak, YuliaPechl, Carlos Eduardo MedinaAkhundm, TauseefullahRomolinin, ValerioCostantini, MarcoMzoloo, ThembileKunnelp, BarryLechevinq, IsabelleAggravir, MariannaTiberis, PaolaNarendrant, K.Martínez, Juan Antonio GarcíaBasile, VenereFragapanem, ElenaLattanzi, MariaPellegrini, Michele2021-11-23T21:22:10Z2021-11-23T21:22:10Z2021DIEZ-DOMINGO, Javier et al. Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults. Human vaccines and immunotherapeutics, 2021.2164-5515https://www.arca.fiocruz.br/handle/icict/4999210.1080/21645515.2021.1981085MOREIRA JUNIOR, Edson Duarte. Fundação Oswalado Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. aVaccine Research Area, FISABIO-Public Health, Valencia, Spain; bInfectious Disease, Hospital General de Durango, Durango, Mexico; cKliiniliste Uuringute Keskus, Tartu, Estonia; dPediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey; eTiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa; fInstituto Hispalense de Pediatria, Seville, Spain; gFaculty of Medicine, Dokuz Eylul University, Izmir, Turkey; hAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil; iSetshaba Research Centre, Tshwane, and Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa; jCentro de Pesquisas Clinicas de Natal, Rio Grande do Norta, Brazil; kInfectious Diseases and Epidemiology, Siberian State Medical University, Tomsk, Russian Federation; lMedical Care and Research SA de CV, Mérida, Mexico; mClinical Research and Development Centre, GSK, Siena, Italy; nBiostatistics, GSK, Siena, Italy; oBiostatistics, GSK, Amsterdam, The Netherlands; pData Strategy & Management, Global Clinical Operations Development – R&D, GSK, Amsterdam, The Netherlands; qClinical Laboratory Sciences, GSK, Rixensart, Belgium; rTechnical Development, GSK, Siena, Italy; sSafety Evaluation and Risk Management, GSK, Siena, Italy; tGlobal Clinical Operations, GSK, Bangalore, India; uMedical Department, GSK, Madrid, Spain; vGlobal Clinical Delivery, Global Clinical Operations Development, GSK, Siena, ItalyGlaxoSmithKline Biologicals SA, which was involved in all stages of study conduct, including analysis of the data. GlaxoSmithKline Biologicals SA also took in charge all costs associated with the development and publication of this manuscript.“Múltipla – ver em notas”A fully liquid MenACWY-CRM vaccine presentation has been developed, modifying the meningococcal serogroup A (MenA) component from lyophilized to liquid. The safety and immunogenicity of the liquid presentation at the end of the intended shelf-life (aged for 24 or 30 months) were compared to the licensed lyophilized/liquid presentation. This multicenter, randomized (1:1), observer-blind, phase 2b study (NCT03433482) enrolled adolescents and young adults (age 10–40 years). In part 1, 844 participants received one dose of liquid presentation stored for approximately 24 months or licensed presentation. In part 2, 846 participants received one dose of liquid presentation stored for approximately 30 months or licensed presentation. After storage, the MenA free saccharide (FS) level was approximately 25% and O-acetylation was approximately 45%. The primary objective was to demonstrate non-inferiority of the liquid presentation to licensed presentation, as measured by human serum bactericidal assay (hSBA) geometric mean titers (GMTs) against MenA, 1-month post-vaccination. Immune responses against each vaccine serogroup were similar between groups. Between-group ratios of hSBA GMTs for MenA were 1.21 (part 1) and 1.11 (part 2), with two-sided 95% confidence interval lower limits (0.94 and 0.87, respectively) greater than the prespecified non-inferiority margin (0.5), thus meeting the primary study objective. No safety concerns were identified. Despite reduced O-acetylation of MenA and increased FS content, serogroup-specific immune responses induced by the fully liquid presentation were similar to those induced by the licensed MenACWY-CRM vaccine, with non-inferior anti-MenA responses. The safety profiles of the vaccine presentations were similar.engTaylor & FrancisNeisseria meningitidis Sorogrupo ATeste Bactericida do SoroAdolescentesInferioridadeVacinaMenACWY-CRMMeningococcal serogroup AHuman serum bactericidal assayNon-inferiorityAdolescentsImmunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adultsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83097https://www.arca.fiocruz.br/bitstream/icict/49992/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALDomingo, Javier Diez..Immunological....pdfDomingo, Javier Diez..Immunological....pdfapplication/pdf2841361https://www.arca.fiocruz.br/bitstream/icict/49992/2/Domingo%2c%20Javier%20Diez..Immunological....pdfd389f4232f17dd27dda0f3b690ec6787MD52icict/499922023-03-15 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dc.title.pt_BR.fl_str_mv	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults
title	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults
spellingShingle	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults Díez-Domingo, Javier Neisseria meningitidis Sorogrupo A Teste Bactericida do Soro Adolescentes Inferioridade Vacina MenACWY-CRM Meningococcal serogroup A Human serum bactericidal assay Non-inferiority Adolescents
title_short	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults
title_full	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults
title_fullStr	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults
title_full_unstemmed	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults
title_sort	Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults
author	Díez-Domingo, Javier
author_facet	Díez-Domingo, Javier Tinoco, Juan Carlos Poderc, Airi Dinleyicid, Ener Cagri Nelle, Haylene Cueva, Ignacio Salamanca de la Inceg, Tolga Moreira Junior, Edson Duarte Ahmedi, Khatija Luzj, Kleber Kovshirinak, Yulia Pechl, Carlos Eduardo Medina Akhundm, Tauseefullah Romolinin, Valerio Costantini, Marco Mzoloo, Thembile Kunnelp, Barry Lechevinq, Isabelle Aggravir, Marianna Tiberis, Paola Narendrant, K. Martínez, Juan Antonio García Basile, Venere Fragapanem, Elena Lattanzi, Maria Pellegrini, Michele
author_role	author
author2	Tinoco, Juan Carlos Poderc, Airi Dinleyicid, Ener Cagri Nelle, Haylene Cueva, Ignacio Salamanca de la Inceg, Tolga Moreira Junior, Edson Duarte Ahmedi, Khatija Luzj, Kleber Kovshirinak, Yulia Pechl, Carlos Eduardo Medina Akhundm, Tauseefullah Romolinin, Valerio Costantini, Marco Mzoloo, Thembile Kunnelp, Barry Lechevinq, Isabelle Aggravir, Marianna Tiberis, Paola Narendrant, K. Martínez, Juan Antonio García Basile, Venere Fragapanem, Elena Lattanzi, Maria Pellegrini, Michele
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	Díez-Domingo, Javier Tinoco, Juan Carlos Poderc, Airi Dinleyicid, Ener Cagri Nelle, Haylene Cueva, Ignacio Salamanca de la Inceg, Tolga Moreira Junior, Edson Duarte Ahmedi, Khatija Luzj, Kleber Kovshirinak, Yulia Pechl, Carlos Eduardo Medina Akhundm, Tauseefullah Romolinin, Valerio Costantini, Marco Mzoloo, Thembile Kunnelp, Barry Lechevinq, Isabelle Aggravir, Marianna Tiberis, Paola Narendrant, K. Martínez, Juan Antonio García Basile, Venere Fragapanem, Elena Lattanzi, Maria Pellegrini, Michele
dc.subject.other.pt_BR.fl_str_mv	Neisseria meningitidis Sorogrupo A Teste Bactericida do Soro Adolescentes Inferioridade Vacina
topic	Neisseria meningitidis Sorogrupo A Teste Bactericida do Soro Adolescentes Inferioridade Vacina MenACWY-CRM Meningococcal serogroup A Human serum bactericidal assay Non-inferiority Adolescents
dc.subject.en.pt_BR.fl_str_mv	MenACWY-CRM Meningococcal serogroup A Human serum bactericidal assay Non-inferiority Adolescents
description	MOREIRA JUNIOR, Edson Duarte. Fundação Oswalado Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. aVaccine Research Area, FISABIO-Public Health, Valencia, Spain; bInfectious Disease, Hospital General de Durango, Durango, Mexico; cKliiniliste Uuringute Keskus, Tartu, Estonia; dPediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey; eTiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa; fInstituto Hispalense de Pediatria, Seville, Spain; gFaculty of Medicine, Dokuz Eylul University, Izmir, Turkey; hAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil; iSetshaba Research Centre, Tshwane, and Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa; jCentro de Pesquisas Clinicas de Natal, Rio Grande do Norta, Brazil; kInfectious Diseases and Epidemiology, Siberian State Medical University, Tomsk, Russian Federation; lMedical Care and Research SA de CV, Mérida, Mexico; mClinical Research and Development Centre, GSK, Siena, Italy; nBiostatistics, GSK, Siena, Italy; oBiostatistics, GSK, Amsterdam, The Netherlands; pData Strategy & Management, Global Clinical Operations Development – R&D, GSK, Amsterdam, The Netherlands; qClinical Laboratory Sciences, GSK, Rixensart, Belgium; rTechnical Development, GSK, Siena, Italy; sSafety Evaluation and Risk Management, GSK, Siena, Italy; tGlobal Clinical Operations, GSK, Bangalore, India; uMedical Department, GSK, Madrid, Spain; vGlobal Clinical Delivery, Global Clinical Operations Development, GSK, Siena, Italy
publishDate	2021
dc.date.accessioned.fl_str_mv	2021-11-23T21:22:10Z
dc.date.available.fl_str_mv	2021-11-23T21:22:10Z
dc.date.issued.fl_str_mv	2021
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.citation.fl_str_mv	DIEZ-DOMINGO, Javier et al. Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults. Human vaccines and immunotherapeutics, 2021.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/49992
dc.identifier.issn.pt_BR.fl_str_mv	2164-5515
dc.identifier.doi.none.fl_str_mv	10.1080/21645515.2021.1981085
identifier_str_mv	DIEZ-DOMINGO, Javier et al. Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults. Human vaccines and immunotherapeutics, 2021. 2164-5515 10.1080/21645515.2021.1981085
url	https://www.arca.fiocruz.br/handle/icict/49992
dc.language.iso.fl_str_mv	eng
language	eng
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Taylor & Francis
publisher.none.fl_str_mv	Taylor & Francis
dc.source.none.fl_str_mv	reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ
instname_str	Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str	FIOCRUZ
institution	FIOCRUZ
reponame_str	Repositório Institucional da FIOCRUZ (ARCA)
collection	Repositório Institucional da FIOCRUZ (ARCA)
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Immunological non-inferiority of a new fully liquid presentation of the MenACWYCRM vaccine to the licensed vaccine: results from a randomized, controlled, observerblind study in adolescents and young adults

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