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Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trial

2021; Elsevier BV; Volume: 8; Issue: 8 Linguagem: Inglês

10.1016/s2352-3018(21)00103-x

2405-4704

John Frater, Katie Ewer, Ane Ogbe, Matthew Pace, Sandra Adele, Emily Adland, Jasmini Alagaratnam, Parvinder K. Aley, Mohammad Ali, M. Azim Ansari, Anna Bara, Mustapha Bittaye, Samantha Broadhead, Anthony Brown, Helen Brown, Federica Cappuccini, Enya Cooney, Wanwisa Dejnirattisai, Christina Dold, Cassandra Fairhead, Henry Fok, Pedro M. Folegatti, Jamie Fowler, Charlotte Gibbs, Anna L. Goodman, Daniel Jenkin, Mathew Jones, Rebecca Makinson, Natalie G. Marchevsky, Yama F Mujadidi, Hanna Nguyen, Lucia Parolini, Claire Petersen, Emma Plested, Katrina M. Pollock, Maheshi Ramasamy, Sarah Rhead, Hannah Robinson, Nicola Robinson, Patpong Rongkard, Fiona Ryan, Sonia Serrano, Timothy Tipoe, Merryn Voysey, Anele Waters, Panagiota Zacharopoulou, Eleanor Barnes, Susanna Dunachie, Philip Goulder, Paul Klenerman, Gavin Screaton, Alan Winston, Adrian V. S. Hill, Sarah C. Gilbert, Andrew J. Pollard, Sarah Fidler, Julie Fox, Teresa Lambe, Marion Watson, Rinn Song, Paola Cicconi, Angela M. Minassian, Sagida Bibi, Simon Kerridge, Nisha Singh, Catherine Green, Alexander D. Douglas, Alison M. Lawrie, Elizabeth Clutterbuck,

COVID-19 Impact on Reproduction

BackgroundData on vaccine immunogenicity against SARS-CoV-2 are needed for the 40 million people globally living with HIV who might have less functional immunity and more associated comorbidities than the general population. We aimed to explore safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in people with HIV.MethodsIn this single-arm open-label vaccination substudy within the protocol of the larger phase 2/3 trial COV002, adults aged 18–55 years with HIV were enrolled at two HIV clinics in London, UK. Eligible participants were required to be on antiretroviral therapy (ART), with undetectable plasma HIV viral loads ( 0·05 for all analyses).InterpretationIn this study of people with HIV, ChAdOx1 nCoV-19 was safe and immunogenic, supporting vaccination for those well controlled on ART.FundingUK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.