Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study

Detalhes bibliográficos
Autor(a) principal: Clemens, Sue Ann Costa
Data de Publicação: 2022
Outros Autores: Weckx, Lily, Clemens, Ralf, Mendes, Ana Verena Almeida, Souza, Alessandra Ramos, Silveira, Mariana B V, Guarda, Suzete Nascimento Farias da, Nobrega, Maristela Miyamoto de, Pinto, Maria Isabel de Moraes, Gonzalez, Isabela G S, Salvador, Natalia, Franco, Marilia Miranda, Mendonça, Renata Navis de Avila, Oliveira, Isabelle Silva Queiroz, Souza, Bruno Solano de Freitas, Fraga, Mayara, Aley, Parvinder, Bibi, Sagida, Cantrell, Liberty, Dejnirattisai, Wanwisa, Liu, Xinxue, Mongkolsapaya, Juthathip, Supasa, Piyada, Screaton, Gavin R, Lambe, Teresa, Voysey, Merryn, Pollard, Andrew J
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/51617
Resumo: Oxford Vaccine Group, Department of Paediatrics. University of Oxford. Oxford, UK / Institute of Global Health. University of Siena. Siena, Italy. Universidade Federal de São Paulo. Departamento de Pediatria. São Paulo, SP, Brasil. International Vaccine Institute. Seoul, Korea. Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brasil / Hospital São Rafael. Medicina Geral. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Hospital São Rafael. Medicina Geral. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil / Universidade Federal da Bahia. Departamento de Pediatria, Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK / Chinese Academy of Medical Science Oxford Institute. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK / Chinese Academy of Medical Science Oxford Institute. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK / NIHR Oxford Biomedical Research Centre. Oxford, UK. NIHR Oxford Biomedical Research Centre. Oxford, UK.
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spelling Clemens, Sue Ann CostaWeckx, LilyClemens, RalfMendes, Ana Verena AlmeidaSouza, Alessandra RamosSilveira, Mariana B VGuarda, Suzete Nascimento Farias daNobrega, Maristela Miyamoto dePinto, Maria Isabel de MoraesGonzalez, Isabela G SSalvador, NataliaFranco, Marilia MirandaMendonça, Renata Navis de AvilaOliveira, Isabelle Silva QueirozSouza, Bruno Solano de FreitasFraga, MayaraAley, ParvinderBibi, SagidaCantrell, LibertyDejnirattisai, WanwisaLiu, XinxueMongkolsapaya, JuthathipSupasa, PiyadaScreaton, Gavin RLambe, TeresaVoysey, MerrynPollard, Andrew J2022-03-08T15:31:46Z2022-03-08T15:31:46Z2022Clemens, Sue Ann Costa et al. Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study. Lancet, v. 399, p. 521-29, 2022.474-547xhttps://www.arca.fiocruz.br/handle/icict/5161710.1016/S0140-6736(22)00094-0Oxford Vaccine Group, Department of Paediatrics. University of Oxford. Oxford, UK / Institute of Global Health. University of Siena. Siena, Italy. Universidade Federal de São Paulo. Departamento de Pediatria. São Paulo, SP, Brasil. International Vaccine Institute. Seoul, Korea. Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brasil / Hospital São Rafael. Medicina Geral. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Hospital São Rafael. Medicina Geral. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil / Universidade Federal da Bahia. Departamento de Pediatria, Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK / Chinese Academy of Medical Science Oxford Institute. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK / Chinese Academy of Medical Science Oxford Institute. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK / NIHR Oxford Biomedical Research Centre. Oxford, UK. NIHR Oxford Biomedical Research Centre. Oxford, UK.Ministério da Saúde, Brasil."Múltipla ver em Notas"Introduction: The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods: RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in São Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer-BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18-60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Clínicos, number RBR-9nn3scw. Findings: Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8-30·1) in adults aged 18-60 years and 8·9% (4·2-16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67-88) for Ad26.COV2-S, 152 (134-173) for BNT162b2, 90 (77-104) for ChAdOx1 nCoV-19, and 12 (11-14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8-7·7) for Ad26.COV2-S, 13·4 (11·6-15·3) for BNT162b2, and 7·0 (6·1-8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9-12·9) for Ad26.COV2-S vaccine, 21·5 (14·5-31·9) for BNT162b2, and 10·6 (7·2-15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation: Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protectionengElsevierCOVID-19VacinasImunidade HeterólogaCOVID-19VaccinesImmunity, HeterologousCOVID-19VacunasInmunidad HeterólogaHeterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised studyinfo: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-82991https://www.arca.fiocruz.br/bitstream/icict/51617/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALCosta, C. Heterologous....pdfCosta, C. 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dc.title.pt_BR.fl_str_mv Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
title Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
spellingShingle Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
Clemens, Sue Ann Costa
COVID-19
Vacinas
Imunidade Heteróloga
COVID-19
Vaccines
Immunity, Heterologous
COVID-19
Vacunas
Inmunidad Heteróloga
title_short Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
title_full Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
title_fullStr Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
title_full_unstemmed Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
title_sort Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study
author Clemens, Sue Ann Costa
author_facet Clemens, Sue Ann Costa
Weckx, Lily
Clemens, Ralf
Mendes, Ana Verena Almeida
Souza, Alessandra Ramos
Silveira, Mariana B V
Guarda, Suzete Nascimento Farias da
Nobrega, Maristela Miyamoto de
Pinto, Maria Isabel de Moraes
Gonzalez, Isabela G S
Salvador, Natalia
Franco, Marilia Miranda
Mendonça, Renata Navis de Avila
Oliveira, Isabelle Silva Queiroz
Souza, Bruno Solano de Freitas
Fraga, Mayara
Aley, Parvinder
Bibi, Sagida
Cantrell, Liberty
Dejnirattisai, Wanwisa
Liu, Xinxue
Mongkolsapaya, Juthathip
Supasa, Piyada
Screaton, Gavin R
Lambe, Teresa
Voysey, Merryn
Pollard, Andrew J
author_role author
author2 Weckx, Lily
Clemens, Ralf
Mendes, Ana Verena Almeida
Souza, Alessandra Ramos
Silveira, Mariana B V
Guarda, Suzete Nascimento Farias da
Nobrega, Maristela Miyamoto de
Pinto, Maria Isabel de Moraes
Gonzalez, Isabela G S
Salvador, Natalia
Franco, Marilia Miranda
Mendonça, Renata Navis de Avila
Oliveira, Isabelle Silva Queiroz
Souza, Bruno Solano de Freitas
Fraga, Mayara
Aley, Parvinder
Bibi, Sagida
Cantrell, Liberty
Dejnirattisai, Wanwisa
Liu, Xinxue
Mongkolsapaya, Juthathip
Supasa, Piyada
Screaton, Gavin R
Lambe, Teresa
Voysey, Merryn
Pollard, Andrew J
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
author
dc.contributor.author.fl_str_mv Clemens, Sue Ann Costa
Weckx, Lily
Clemens, Ralf
Mendes, Ana Verena Almeida
Souza, Alessandra Ramos
Silveira, Mariana B V
Guarda, Suzete Nascimento Farias da
Nobrega, Maristela Miyamoto de
Pinto, Maria Isabel de Moraes
Gonzalez, Isabela G S
Salvador, Natalia
Franco, Marilia Miranda
Mendonça, Renata Navis de Avila
Oliveira, Isabelle Silva Queiroz
Souza, Bruno Solano de Freitas
Fraga, Mayara
Aley, Parvinder
Bibi, Sagida
Cantrell, Liberty
Dejnirattisai, Wanwisa
Liu, Xinxue
Mongkolsapaya, Juthathip
Supasa, Piyada
Screaton, Gavin R
Lambe, Teresa
Voysey, Merryn
Pollard, Andrew J
dc.subject.other.pt_BR.fl_str_mv COVID-19
Vacinas
Imunidade Heteróloga
topic COVID-19
Vacinas
Imunidade Heteróloga
COVID-19
Vaccines
Immunity, Heterologous
COVID-19
Vacunas
Inmunidad Heteróloga
dc.subject.en.pt_BR.fl_str_mv COVID-19
Vaccines
Immunity, Heterologous
dc.subject.es.pt_BR.fl_str_mv COVID-19
Vacunas
Inmunidad Heteróloga
description Oxford Vaccine Group, Department of Paediatrics. University of Oxford. Oxford, UK / Institute of Global Health. University of Siena. Siena, Italy. Universidade Federal de São Paulo. Departamento de Pediatria. São Paulo, SP, Brasil. International Vaccine Institute. Seoul, Korea. Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brasil / Hospital São Rafael. Medicina Geral. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Hospital São Rafael. Medicina Geral. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil / Universidade Federal da Bahia. Departamento de Pediatria, Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Universidade Federal de São Paulo. São Paulo, SP, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Hospital São Rafael. General Medicine. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino, Salvador, BA, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK. Wellcome Centre for Human Genetics. Nuffield Department of Medicine. University of Oxford. Oxford, UK / Chinese Academy of Medical Science Oxford Institute. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK / Chinese Academy of Medical Science Oxford Institute. University of Oxford. Oxford, UK. Oxford Vaccine Group. Department of Paediatrics. University of Oxford. Oxford, UK / NIHR Oxford Biomedical Research Centre. Oxford, UK. NIHR Oxford Biomedical Research Centre. Oxford, UK.
publishDate 2022
dc.date.accessioned.fl_str_mv 2022-03-08T15:31:46Z
dc.date.available.fl_str_mv 2022-03-08T15:31:46Z
dc.date.issued.fl_str_mv 2022
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv Clemens, Sue Ann Costa et al. Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study. Lancet, v. 399, p. 521-29, 2022.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/51617
dc.identifier.issn.pt_BR.fl_str_mv 474-547x
dc.identifier.doi.none.fl_str_mv 10.1016/S0140-6736(22)00094-0
identifier_str_mv Clemens, Sue Ann Costa et al. Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study. Lancet, v. 399, p. 521-29, 2022.
474-547x
10.1016/S0140-6736(22)00094-0
url https://www.arca.fiocruz.br/handle/icict/51617
dc.language.iso.fl_str_mv eng
language eng
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dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/51617/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/51617/2/Costa%2c%20C.%20Heterologous....pdf
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