1. 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
- Author
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Federica Cappuccini, P Cicconi, M Pace, Susanna Dunachie, Nishanta Singh, Catherine M. Green, Eleanor Barnes, Matthew Jones, J Fowler, Sarah C. Gilbert, N G Marchevsky, T Tipoe, C Fairhead, Yama F Mujadidi, M A Ansari, Teresa Lambe, S Serrano, P Goulder, P Zacharopoulou, S Broadhead, S Adele, F Ryan, Katie J. Ewer, L Parolini, Simon Kerridge, D Jenkin, Cooney E, Anele Waters, Christina Dold, Hill Avs., Parvinder K. Aley, Anthony Brown, Alison M. Lawrie, R Song, Paul Klenerman, Alexander D. Douglas, M Bittaye, M N Ramasamy, John Frater, Sarah Fidler, H Fok, Hannah Robinson, Mohammed K. Ali, Emily Adland, Angela M. Minassian, Julie Fox, Wanwisa Dejnirattisai, P M Folegatti, P Rongkard, C Petersen, Harriet R. Brown, Elizabeth A. Clutterbuck, Watson Mee., C Gibbs, N Robinson, Merryn Voysey, Emma Plested, J Alagaratnam, A Ogbe, S Bibi, A Bara, Alissa Goodman, Alan Winston, R Makinson, H Nguyen, Andrew J. Pollard, Gavin R. Screaton, S Rhead, Katrina M Pollock, Group, Oxford COVID Vaccine Trial, Imperial College Healthcare NHS Trust- BRC Funding, and Medical Research Council (MRC)
- Subjects
Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,COVID-19 Vaccines ,Epidemiology ,Immunology ,Population ,HIV Infections ,Antibodies, Viral ,03 medical and health sciences ,0302 clinical medicine ,Oxford COVID Vaccine Trial Group ,ChAdOx1 nCoV-19 ,Virology ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,education ,Adverse effect ,11 Medical and Health Sciences ,education.field_of_study ,SARS-CoV-2 ,business.industry ,Immunogenicity ,Comment ,Vaccination ,COVID-19 ,Articles ,Middle Aged ,030112 virology ,CD4 Lymphocyte Count ,Clinical trial ,Infectious Diseases ,Clinical research ,Chills ,medicine.symptom ,business ,Viral load - Abstract
Background: data 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. Methods: in 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). Interpretation: in this study of people with HIV, ChAdOx1 nCoV-19 was safe and immunogenic, supporting vaccination for those well controlled on ART. Funding: UK 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.
- Published
- 2021