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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.
Frater, John; Ewer, Katie J; Ogbe, Ane; Pace, Mathew; Adele, Sandra; Adland, Emily; Alagaratnam, Jasmini; Aley, Parvinder K; Ali, Mohammad; Ansari, M Azim; Bara, Anna; Bittaye, Mustapha; Broadhead, Samantha; Brown, Anthony; Brown, Helen; Cappuccini, Federica; Cooney, Enya; Dejnirattisai, Wanwisa; Dold, Christina; Fairhead, Cassandra; Fok, Henry; Folegatti, Pedro M; Fowler, Jamie; Gibbs, Charlotte; Goodman, Anna L; Jenkin, Daniel; Jones, Mathew; Makinson, Rebecca; Marchevsky, Natalie G; Mujadidi, Yama F; Nguyen, Hanna; Parolini, Lucia; Petersen, Claire; Plested, Emma; Pollock, Katrina M; Ramasamy, Maheshi N; Rhead, Sarah; Robinson, Hannah; Robinson, Nicola; Rongkard, Patpong; Ryan, Fiona; Serrano, Sonia; Tipoe, Timothy; Voysey, Merryn; Waters, Anele; Zacharopoulou, Panagiota; Barnes, Eleanor; Dunachie, Susanna; Goulder, Philip; Klenerman, Paul.
  • Frater J; Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: john.frater@ndm.ox.ac.uk.
  • Ewer KJ; The Jenner Institute, University of Oxford, Oxford, UK.
  • Ogbe A; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Pace M; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Adele S; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Adland E; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK; Department of Paediatrics, University of Oxford, Oxford, UK.
  • Alagaratnam J; Department of Infectious Disease, Faculty of Medicine, Imperial College London, London, UK; Department of HIV Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.
  • Aley PK; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Ali M; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Ansari MA; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Bara A; NIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
  • Bittaye M; The Jenner Institute, University of Oxford, Oxford, UK.
  • Broadhead S; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Brown A; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Brown H; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Cappuccini F; The Jenner Institute, University of Oxford, Oxford, UK.
  • Cooney E; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Dejnirattisai W; Wellcome Centre for Human Genetics, University of Oxford, Oxford, UK.
  • Dold C; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Fairhead C; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Fok H; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Folegatti PM; The Jenner Institute, University of Oxford, Oxford, UK.
  • Fowler J; The Jenner Institute, University of Oxford, Oxford, UK.
  • Gibbs C; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Goodman AL; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Jenkin D; The Jenner Institute, University of Oxford, Oxford, UK.
  • Jones M; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Makinson R; The Jenner Institute, University of Oxford, Oxford, UK.
  • Marchevsky NG; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Mujadidi YF; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Nguyen H; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Parolini L; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Petersen C; Department of Infectious Disease, Faculty of Medicine, Imperial College London, London, UK; Department of HIV Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.
  • Plested E; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Pollock KM; NIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
  • Ramasamy MN; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Rhead S; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Robinson H; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Robinson N; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
  • Rongkard P; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Ryan F; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Serrano S; NIHR Guy's and St Thomas' Biomedical Research Centre, London, UK.
  • Tipoe T; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Voysey M; Nuffield Department of Clinical Medicine and Oxford Vaccine Group, University of Oxford, Oxford, UK.
  • Waters A; Department of Infection, Harrison Wing and NIHR Clinical Research Facility, Guys and St Thomas' NHS Trust, London, UK.
  • Zacharopoulou P; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Barnes E; Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK; The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
  • Dunachie S; Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok,
  • Goulder P; Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK; Department of Paediatrics, University of Oxford, Oxford, UK.
  • Klenerman P; Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Lancet HIV ; 8(8): e474-e485, 2021 08.
Article in English | MEDLINE | ID: covidwho-1275800
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 (<50 copies per mL), and CD4 counts of more than 350 cells per µL. A prime-boost regimen of ChAdOx1 nCoV-19, with two doses was given 4-6 weeks apart. The primary outcomes for this substudy were safety and reactogenicity of the vaccine, as determined by serious adverse events and solicited local and systemic reactions. Humoral responses were measured by anti-spike IgG ELISA and antibody-mediated live virus neutralisation. Cell-mediated immune responses were measured by ex-vivo IFN-γ enzyme-linked immunospot assay (ELISpot) and T-cell proliferation. All outcomes were compared with an HIV-uninfected group from the main COV002 study within the same age group and dosing strategy and are reported until day 56 after prime vaccination. Outcomes were analysed in all participants who received both doses and with available samples. The COV002 study is registered with ClinicalTrials.gov, NCT04400838, and is ongoing.

FINDINGS:

Between Nov 5 and Nov 24, 2020, 54 participants with HIV (all male, median age 42·5 years [IQR 37·2-49·8]) were enrolled and received two doses of ChAdOx1 nCoV-19. Median CD4 count at enrolment was 694·0 cells per µL (IQR 573·5-859·5). No serious adverse events occurred. Local and systemic reactions occurring during the first 7 days after prime vaccination included pain at the injection site (26 [49%] of 53 participants with available data), fatigue (25 [47%]), headache (25 [47%]), malaise (18 [34%]), chills (12 [23%]), muscle ache (19 [36%]), joint pain (five [9%]), and nausea (four [8%]), the frequencies of which were similar to the HIV-negative participants. Anti-spike IgG responses by ELISA peaked at day 42 (median 1440 ELISA units [EUs; IQR 704-2728]; n=50) and were sustained until day 56 (median 941 EUs [531-1445]; n=49). We found no correlation between the magnitude of the anti-spike IgG response at day 56 and CD4 cell count (p=0·93) or age (p=0·48). ELISpot and T-cell proliferative responses peaked at day 14 and 28 after prime dose and were sustained to day 56. Compared with participants without HIV, we found no difference in magnitude or persistence of SARS-CoV-2 spike-specific humoral or cellular responses (p>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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: HIV Infections / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans / Male / Middle aged Language: English Journal: Lancet HIV Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: HIV Infections / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans / Male / Middle aged Language: English Journal: Lancet HIV Year: 2021 Document Type: Article