Antibody Response After the Third SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients and People Living With HIV (COVERALL-2).

Autor: Griessbach A; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland., Chammartin F; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland., Abela IA; Institute of Medical Virology, University of Zurich, Zurich, Switzerland.; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Amico P; Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland., Stoeckle MP; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, University of Basel, Basel, Switzerland., Eichenberger AL; Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Hasse B; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Braun DL; Institute of Medical Virology, University of Zurich, Zurich, Switzerland.; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Schuurmans MM; Division of Pulmonology, University Hospital Zurich, Zurich, Switzerland., Müller TF; Nephrology Clinic, University Hospital Zurich, Zurich, Switzerland., Tamm M; Clinic of Respiratory Medicine and Pulmonary Cell Research, University Hospital Basel, Basel, Switzerland., Audigé A; Institute of Medical Virology, University of Zurich, Zurich, Switzerland., Mueller NJ; Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland., Rauch A; Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Günthard HF; Institute of Medical Virology, University of Zurich, Zurich, Switzerland.; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Koller MT; Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.; Swiss Transplant Cohort Study, University Hospital Basel, Basel, Switzerland., Trkola A; Institute of Medical Virology, University of Zurich, Zurich, Switzerland., Epp S; Institute of Medical Virology, University of Zurich, Zurich, Switzerland., Amstutz A; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland., Schönenberger CM; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland., Taji Heravi A; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland., Papadimitriou-Olivgeris M; Infectious Diseases Service and Transplantation Center, Lausanne University Hospital, Lausanne, Switzerland., Casutt A; Division of Pulmonology, Department of Medicine, University Hospital of Lausanne, Lausanne, Switzerland., Manuel O; Infectious Diseases Service and Transplantation Center, Lausanne University Hospital, Lausanne, Switzerland., Kusejko K; Institute of Medical Virology, University of Zurich, Zurich, Switzerland.; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Bucher HC; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, University of Basel, Basel, Switzerland., Briel M; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada., Speich B; Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2023 Nov 03; Vol. 10 (11), pp. ofad536. Date of Electronic Publication: 2023 Nov 03 (Print Publication: 2023).
DOI: 10.1093/ofid/ofad536
Abstrakt: Background: After basic immunization with 2 mRNA SARS-CoV-2 vaccine doses, only a small proportion of patients who are severely immunocompromised generate a sufficient antibody response. Hence, we assessed the additional benefit of a third SARS-CoV-2 vaccine in patients with different levels of immunosuppression.
Methods: In this observational extension of the COVERALL trial (Corona Vaccine Trial Platform), we recruited patients from the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study (ie, lung and kidney transplant recipients). We collected blood samples before and 8 weeks after the third SARS-CoV-2 vaccination with either mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech). The primary outcome was the proportion of participants showing an antibody response (Elecsys Anti-SARS-CoV-2 S test; threshold ≥100 U/mL) 8 weeks after the third SARS-CoV-2 vaccination. We also compared the proportion of patients who reached the primary outcome from basic immunization (the first and second vaccines) to the third vaccination.
Results: Nearly all participants (97.2% [95% CI, 95.9%-98.6%], 564/580) had an antibody response. This response was comparable between mRNA-1273 (96.1% [95% CI, 93.7%-98.6%], 245/255) and BNT162b2 (98.2% [95% CI, 96.7%-99.6%], 319/325). Stratification by cohort showed that 99.8% (502/503) of people living with HIV and 80.5% (62/77) of recipients of solid organ transplants achieved the primary endpoint. The proportion of patients with an antibody response in solid organ transplant recipients improved from the second vaccination (22.7%, 15/66) to the third (80.5%, 62/77).
Conclusions: People living with HIV had a high antibody response. The third vaccine increased the proportion of solid organ transplant recipients with an antibody response. Clinical Trials Registration.  NCT04805125 (ClinicalTrials.gov).
Competing Interests: Potential conflicts of interest. H. C. B. has received, in the 36 months prior to the submission of this manuscript, grants, support for traveling, consultancy fees, and honorarium from Gilead, BMS, ViiV Healthcare, Roche, and Pfizer that were not related to this project. He served as the president of the Association contre le HIV et autres infections transmissibles from 2007 to June 2022. In this function, he received support for the Swiss HIV Cohort Study from ViiV Healthcare, Gilead, BMS, and MSD. A. T. received a consultant fee from Roche and unrestricted research funding from Gilead and Roche not related to this study. D. L. B. received honoraria for advisory boards from Gilead, MSD, Pfizer, AstraZeneca, and ViiV outside of the study. H. F. G., outside of this study, reports grants from the Swiss National Science Foundation, National Institutes of Health, and the SHCS; unrestricted research grants from Gilead Sciences and the Yvonne Jacob Foundation; and personal fees from consulting, advisory boards, or data safety monitoring boards for Merck, Gilead Sciences, ViiV Healthcare, Janssen, Johnson & Johnson, GSK, and Novartis. H. F. G.’s institution received money for participation in the following clinical COVID-19 studies: 540-7773/5774 (Gilead), TICO (ACTIV-3, INSIGHT/National Institutes of Health), and Morningsky (Roche). A. R. reports support to his institution for advisory boards and/or travel grants from MSD, Gilead Sciences, and Pfizer and an investigator-initiated trial grant from Gilead Sciences; all remuneration went to his home institution and not to A. R. personally, and all remuneration was provided outside the submitted work. A. T., outside of this study, reports SARS-CoV-2 serology grants from the Swiss National Science Foundation, the SHCS, and an unrestricted research grant from Gilead Sciences. All other authors report no potential conflicts.
(© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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