Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2021 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/51175 |
Resumo: | Bruno Solano de Freitas Souza - Fundação Oswaldo Cruz. Instituto Gonçalo Muniz. Salvador, BA, Brasil. |
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Clemens, Sue Ann CostaWeck, LilyClemen, RalfMendes, Ana Verena AlmeidaSouza, Alessandra RamosSilveira, Mariana B. V.Guarda, Suzete Nascimento Farias daNobrega, Maristela Miyamoto dePinto, Maria Isabel de MoraesGonzalez, Isabela G. S.Salvador, NataliaFranco, Marilia MirandaMendonça, Renata Navis de AvilaOliveira, Isabelle Silva QueirozSouza, Bruno Solano de FreitasFraga, MayaraAley, ParvinderBibi, SagidaCantrell, LibertyLambe, TeresaVoysey, MerrynPollard, Andrew J.2022-02-14T15:01:18Z2022-02-14T15:01:18Z2021CLEMENS, Sue Ann Costa. Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine. The Lancet, p. 1-32, 2021.https://www.arca.fiocruz.br/handle/icict/51175Bruno Solano de Freitas Souza - Fundação Oswaldo Cruz. Instituto Gonçalo Muniz. Salvador, BA, Brasil.Oxford Vaccine Group. Department of Paediatrics. University of Oxford, Oxford, UK / Institute of Global Health. University of 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. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, BA, Brasil. Universidade Federal de São Paulo. São Paulo, BA, Brasil. Hospital São Rafael. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil / Universidade Federal da Bahia. Salvador, BA, Brasil. Universidade Federal de São Paulo. São Paulo, BA, Brasil. Universidade Federal de São Paulo. São Paulo, BA, Brasil. Universidade Federal de São Paulo. São Paulo, BA, Brasil. Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Hospital São Rafael. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Hospital São Rafael. Salvador, BA, Brasil / Instituto D'Or de Pesquisa e Ensino. Salvador, BA, Brasil. Hospital São Rafael. 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. 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. Oxford Vaccine Group. Department of Paediatrics. University of Oxford, Oxford, UK / NIHR Oxford Biomedical Research Centre. Oxford, UK.Ministério da Saúde do Brasil.Múltipla - ver em Notas.The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) is one of the most widely used COVID-19 vaccines and is administered in a two-dose schedule. A third dose of the homologous or a different vaccine may boost waning immunity and provide improved protection particularly against new coronavirus variants. Methods: We conducted a phase 4 randomised single-blind two-centre safety and immunogenicity study of a third heterologous booster dose of either the recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), an mRNA vaccine (BNT162b2, Pfizer/BioNTech), or a recombinant adenoviral vectored vaccine (AD26.COV2-S, Janssen), compared with a third homologous booster dose of CoronaVac in Brazilian adults who had received two doses of CoronaVac 6 months previously. 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. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events and serious adverse events. Results: Between 16 August 2021 and 1 September 2021, 1240 participants were randomised in São Paulo and Salvador, of whom 1239 were vaccinated. 1205 returned for their Day 28 visit and were eligible for inclusion in the primary analysis. Antibody levels were low prior to administration of a booster dose with 20.4 % (CI) of adults aged 18-60 years and 8.9% (CI) of older adults (aged more than 60 years) having detectable neutralising antibodies. At Day 28 after the booster vaccine all groups had a substantial rise in IgG antibody levels. The geometric fold-rise from baseline to day 28 was 90 (95%CI 77, 104) for ChAdOx1 nCoV-19, 12 (95%CI 11, 14) for CoronaVac, 77 (95%CI 67, 88) for AD26.COV2-S, and 152 (95%CI 134, 173) for BNT162b2. All heterologous regimes had anti-spike IgG responses at Day 28 that were superior to homologous booster responses. Geometric mean ratios (heterologous vs homologous) were 7.0 (95%CI 6.1, 8.1) for ChAdOx1 nCoV-19, 6.7 (95% CI 5.8, 7.7) for AD26.COV2-S vaccine, and 13.4 (95% CI 11.6, 15.3) for BNT162b2. All heterologous boost regimens induced high levels of pseudovirus neutralising antibodies with 100% seropositivity in all groups except for the homologous boost in older adults which achieved 66.7% seropositivity. Geometric mean ratios (heterologous vs homologous) were 10.6 (95%CI 7.2, 15.6) for ChAdOx1 nCoV-19, 8.7 (95% CI 5.9, 12.9) for AD26.COV2-S vaccine, and 21.5 (95% CI 14.5, 31.9) for BNT162b2. Conclusion: Antibody responses were low at 6 months after prior immunisation with two doses of CoronaVac, However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibody, which may improve protection against infection.engElsevierImunogenicidade da VacinaCOVID-19PandemiaProteçãoImmunogenicity, VaccineCOVID-19PandemicProtectionRandomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccineinfo: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/51175/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALClemens Sue Ann etal - Randomized immunogenicity and safety study of heterologous versus.pdfClemens Sue Ann etal - Randomized immunogenicity and safety study of heterologous versus.pdfapplication/pdf1123273https://www.arca.fiocruz.br/bitstream/icict/51175/2/Clemens%20Sue%20Ann%20etal%20-%20Randomized%20immunogenicity%20and%20safety%20study%20of%20heterologous%20versus.pdf3f87486e1f343e772d1ad8a4f8ee9238MD52icict/511752022-03-25 22:26:35.182oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352022-03-26T01:26:35Repositório Institucional da FIOCRUZ (ARCA) - 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| dc.title.pt_BR.fl_str_mv |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine |
| title |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine |
| spellingShingle |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine Clemens, Sue Ann Costa Imunogenicidade da Vacina COVID-19 Pandemia Proteção Immunogenicity, Vaccine COVID-19 Pandemic Protection |
| title_short |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine |
| title_full |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine |
| title_fullStr |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine |
| title_full_unstemmed |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine |
| title_sort |
Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine |
| author |
Clemens, Sue Ann Costa |
| author_facet |
Clemens, Sue Ann Costa Weck, Lily Clemen, 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 Lambe, Teresa Voysey, Merryn Pollard, Andrew J. |
| author_role |
author |
| author2 |
Weck, Lily Clemen, 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 Lambe, Teresa Voysey, Merryn Pollard, Andrew J. |
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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 Weck, Lily Clemen, 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 Lambe, Teresa Voysey, Merryn Pollard, Andrew J. |
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Imunogenicidade da Vacina COVID-19 Pandemia Proteção |
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Imunogenicidade da Vacina COVID-19 Pandemia Proteção Immunogenicity, Vaccine COVID-19 Pandemic Protection |
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Immunogenicity, Vaccine COVID-19 Pandemic Protection |
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Bruno Solano de Freitas Souza - Fundação Oswaldo Cruz. Instituto Gonçalo Muniz. Salvador, BA, Brasil. |
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2021 |
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2021 |
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2022-02-14T15:01:18Z |
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2022-02-14T15:01:18Z |
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CLEMENS, Sue Ann Costa. Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine. The Lancet, p. 1-32, 2021. |
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https://www.arca.fiocruz.br/handle/icict/51175 |
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CLEMENS, Sue Ann Costa. Randomized immunogenicity and safety study of heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine. The Lancet, p. 1-32, 2021. |
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