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Efficacy of primary series AZD1222 (ChAdOx1 nCoV-19) vaccination against SARS-CoV-2 variants of concern: Final analysis of a randomized, placebo-controlled, phase 1b/2 study in South African adults (COV005).
Koen, Anthonet L; Izu, Alane; Baillie, Vicky; Kwatra, Gaurav; Cutland, Clare L; Fairlie, Lee; Padayachee, Sherman D; Dheda, Keertan; Barnabas, Shaun L; Bhorat, Qasim Ebrahim; Briner, Carmen; Ahmed, Khatija; Bhikha, Sutika; Bhiman, Jinal N; du Plessis, Jeanine; Esmail, Aliasgar; Horne, Elizea; Hwa, Shi-Hsia; Oommen-Jose, Aylin; Lambe, Teresa; Laubscher, Matt; Malahleha, Mookho; Benade, Gabriella; McKenzie, Shakeel; Oelofse, Suzette; Patel, Faeezah; Pillay, Sureshnee; Rhead, Sarah; Rodel, Hylton; Taoushanis, Carol; Tegally, Houriiyah; Thombrayil, Asha; Villafana, Tonya L; Gilbert, Sarah; Pollard, Andrew J; Madhi, Shabir A.
Afiliação
  • Koen AL; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Izu A; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Baillie V; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Kwatra G; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Clinical Microbiology, Christian Medical College, Vellore, India.
  • Cutland CL; African Leadership in Vaccinology Expertise (ALIVE), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Fairlie L; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Padayachee SD; Setshaba Research Centre, Tshwane, South Africa.
  • Dheda K; Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute, University of Cape Town, South Africa.
  • Barnabas SL; Family Centre for Research with Ubuntu, Department of Paediatrics, Stellenbosch University, Cape Town, South Africa.
  • Bhorat QE; Soweto Clinical Trials Centre, Soweto, South Africa.
  • Briner C; Perinatal HIV Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
  • Ahmed K; Setshaba Research Centre, Tshwane, South Africa; Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa.
  • Bhikha S; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Bhiman JN; National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS), Johannesburg, South Africa; SAMRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • du Plessis J; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Esmail A; Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town Lung Institute, Cape Town, South Africa.
  • Horne E; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Hwa SH; Africa Health Research Institute, Durban, South Africa; Division of Infection and Immunity, University College London, London, UK.
  • Oommen-Jose A; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Lambe T; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, UK; Chinese Academy of Medical Science, Oxford Institute, University of Oxford, Oxford, UK.
  • Laubscher M; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Malahleha M; Setshaba Research Centre, Tshwane, South Africa; Synergy Biomed Research Institute, East London, Eastern Cape, South Africa.
  • Benade G; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • McKenzie S; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Oelofse S; Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town Lung Institute, Cape Town, South Africa.
  • Patel F; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Pillay S; KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), School of Laboratory Medicine & Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; Centre for Epidemic Response and Innovation (CERI), Stellenbosch University, Stellenbosch, South Africa.
  • Rhead S; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, UK.
  • Rodel H; Africa Health Research Institute, Durban, South Africa; Division of Infection and Immunity, University College London, London, UK.
  • Taoushanis C; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Tegally H; KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), School of Laboratory Medicine & Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; Centre for Epidemic Response and Innovation (CERI), Stellenbosch University, Stellenbosch, South Africa.
  • Thombrayil A; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Villafana TL; Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Gilbert S; Nuffield Department of Medicine, University of Oxford, ORCRB, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
  • Pollard AJ; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
  • Madhi SA; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: shabir.madhi@wits.ac.za.
Vaccine ; 41(23): 3486-3492, 2023 05 26.
Article em En | MEDLINE | ID: mdl-37149443
ABSTRACT
COVID-19 vaccine efficacy (VE) has been observed to vary against antigenically distinct SARS-CoV-2 variants of concern (VoC). Here we report the final analysis of VE and safety from COV005 a phase 1b/2, multicenter, double-blind, randomized, placebo-controlled study of primary series AZD1222 (ChAdOx1 nCoV-19) vaccination in South African adults aged 18-65 years. South Africa's first, second, and third waves of SARS-CoV-2 infections were respectively driven by the ancestral SARS-CoV-2 virus (wild type, WT), and SARS-CoV-2 Beta and Delta VoCs. VE against asymptomatic and symptomatic infection was 90.6% for WT, 6.7% for Beta and 77.1% for Delta. No cases of severe COVID-19 were documented ahead of unblinding. Safety was consistent with the interim analysis, with no new safety concerns identified. Notably, South Africa's Delta wave occurred ≥ 9 months after primary series vaccination, suggesting that primary series AZD1222 vaccination offers a good durability of protection, potentially due to an anamnestic response. Clinical trial identifier CT.gov NCT04444674.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Adult / Humans País/Região como assunto: Africa Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
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Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Adult / Humans País/Região como assunto: Africa Idioma: En Ano de publicação: 2023 Tipo de documento: Article