Durability of ChAdOx1 nCov-19 (AZD1222) vaccination in people living with HIV - responses to SARS-CoV-2, variants of concern and circulating coronaviruses

medrxiv(2021)

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摘要
Duration of protection from SARS-CoV-2 infection in people with HIV (PWH) following vaccination is unclear. In a sub-study of the phase 2/3 the COV002 trial ([NCT04400838][1]), 54 HIV positive male participants on antiretroviral therapy (undetectable viral loads, CD4+ T cells >350 cells/ul) received two doses of ChAdOx1 nCoV-19 (AZD1222) 4-6 weeks apart and were followed for 6 months. Responses to vaccination were determined by serology (IgG ELISA and MesoScale Discovery (MSD)), neutralisation, ACE-2 inhibition, gamma interferon ELISpot, activation-induced marker (AIM) assay and T cell proliferation. We show that 6 months after vaccination the majority of measurable immune responses were greater than pre-vaccination baseline, but with evidence of a decline in both humoral and cell mediated immunity. There was, however, no significant difference compared to a cohort of HIV-uninfected individuals vaccinated with the same regimen. Responses to the variants of concern were detectable, although were lower than wild type. Pre-existing cross-reactive T cell responses to SARS-CoV-2 spike were associated with greater post-vaccine immunity and correlated with prior exposure to beta coronaviruses. These data support the on-going policy to vaccinate PWH against SARS-CoV-2, and underpin the need for long-term monitoring of responses after vaccination. ### Competing Interest Statement Oxford University has entered into a partnership with AstraZeneca for further development of ChAdOx1 nCoV-19 (AZD1222). SCG is cofounder of Vaccitech (a collaborator in the early development of this vaccine candidate) and named as an inventor on a patent covering use of ChAdOx1-vectored vaccines (PCT/GB2012/000467) and a patent application covering this SARS-CoV-2 vaccine. TL is named as an inventor on a patent application covering this SARS-CoV-2 vaccine and was consultant to Vaccitech. PMF is a consultant to Vaccitech and has received research funding from the Brazilian Government. AJP is Chair of the UK Department of Health and Social Care's Joint Committee on Vaccination and Immunisation, but does not participate in policy advice on SARS-CoV-2 vaccines, and is a member of the WHO Strategic Advisory Group of Experts. AVSH is a cofounder of and consultant to Vaccitech and is named as an inventor on a patent covering design and use of ChAdOx1-vectored vaccines (PCT/GB2012/000467). SF is a consultant to Immunocore. GRS has received funding from Schmidt Futures and Wellcome Trust, consulting fees from GSK Vaccines Strategic Advisory Board, has patents on SARS-CoV-2 monoclonal antibodies, has leadership roles on Oxford University Council and Oxford University Hospitals NHS Foundation Trust, and holds stock in GSK. KP reports grants from the UK Medical Research Council UK Research and Innovation and National Institute of Health Research (NIHR) Vaccine Taskforce for RNA vaccine trial, COVAC1, and honoraria for Sanofi strategic advisory boards. All other authors declare no competing interests. ### Clinical Trial NCT04400838 ### Funding Statement We acknowledge support from Thames Valley and South Midland's NIHR Clinical Research Network and the staff and resources of NIHR Southampton Clinical Research Facility and the NIHR Oxford HThis Article reports independent research funded by UK Research and Innovation (MC/PC/19055), Engineering and Physical Sciences Research Council (EP/R013756/1), Coalition for Epidemic Preparedness Innovations, and NIHR. We acknowledge support from Thames Valley and South Midland's NIHR Clinical Research Network and the staff and resources of NIHR Southampton Clinical Research Facility and the NIHR Oxford Health Biomedical Research Centre. PMF received funding from the Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Brazil (finance code 001). ALF was supported by the Chinese Academy of Medical Sciences Innovation Fund for Medical Science, China (grant number 2018/I2M/2/002). MAA is supported by the Wellcome Trust and Royal Society (220171/Z/20/Z). KJE is an NIHR Biomedical Research Centre senior research fellow. AJP and EB are NIHR senior investigators. M.C., S.L. and ToT. are funded by a U.S. Food and Drug Administration Medical Countermeasures Initiative grant 75F40120C00085. The views expressed in this publication are those of the authors and not necessarily those of the NIHR, FDA or the UK Department of Health and Social Care. We thank the volunteers who participated in this study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Study approval in the UK was done by the Medicines and Healthcare products Regulatory Agency (reference 21584/0424/001-0001) and the South Central Berkshire Research Ethics Committee (reference 20/SC/0145) All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes not applicable [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04400838&atom=%2Fmedrxiv%2Fearly%2F2021%2F09%2F29%2F2021.09.28.21264207.atom
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coronaviruses,hiv,vaccination,sars-cov
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