Antibody and T-Cell Response to Bivalent Booster SARS-CoV-2 Vaccines in People With Compromised Immune Function: COVERALL-3 Study

Bivalent messenger RNA (mRNA) vaccines, designed to combat emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, incorporate ancestral strains and a new variant. Our study assessed the immune response in previously vaccinated individuals of the Swiss HIV Cohort Study (SHCS)...

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Published inThe Journal of infectious diseases Vol. 230; no. 4; pp. e847 - e859
Main Authors Amstutz, Alain, Chammartin, Frédérique, Audigé, Annette, Eichenberger, Anna L, Braun, Dominique L, Amico, Patrizia, Stoeckle, Marcel P, Hasse, Barbara, Papadimitriou-Olivgeris, Matthaios, Manuel, Oriol, Bongard, Cédric, Schuurmans, Macé M, Hage, René, Damm, Dominik, Tamm, Michael, Mueller, Nicolas J, Rauch, Andri, Günthard, Huldrych F, Koller, Michael T, Schönenberger, Christof M, Griessbach, Alexandra, Labhardt, Niklaus D, Kouyos, Roger D, Trkola, Alexandra, Kusejko, Katharina, Bucher, Heiner C, Abela, Irene A, Briel, Matthias, Speich, Benjamin
Format Journal Article
LanguageEnglish
Published United States Oxford University Press 16.10.2024
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Summary:Bivalent messenger RNA (mRNA) vaccines, designed to combat emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, incorporate ancestral strains and a new variant. Our study assessed the immune response in previously vaccinated individuals of the Swiss HIV Cohort Study (SHCS) and the Swiss Transplant Cohort Study (STCS) following bivalent mRNA vaccination. Eligible SHCS and STCS participants received approved bivalent mRNA SARS-CoV-2 vaccines (mRNA-1273.214 or BA.1-adapted BNT162b2) within clinical routine. Blood samples were collected at baseline, 4 weeks, 8 weeks, and 6 months postvaccination. We analyzed the proportion of participants with anti-spike protein antibody response ≥1642 units/mL (indicating protection against SARS-CoV-2 infection), and in a subsample T-cell response (including mean concentrations), stratifying results by cohorts and population characteristics. In SHCS participants, baseline anti-spike antibody concentrations ≥1642 units/mL were observed in 87% (96/112), reaching nearly 100% at follow-ups. Among STCS participants, 58% (35/60) had baseline antibodies ≥1642 units/mL, increasing to 80% at 6 months. Except for lung transplant recipients, all participants showed a 5-fold increase in geometric mean antibody concentrations at 4 weeks and a reduction by half at 6 months. At baseline, T-cell responses were positive in 96% (26/27) of SHCS participants and 36% (16/45) of STCS participants (moderate increase to 53% at 6 months). Few participants reported SARS-CoV-2 infections, side-effects, or serious adverse events. Bivalent mRNA vaccination elicited a robust humoral response in individuals with human immunodeficiency virus (HIV) or solid organ transplants, with delayed responses in lung transplant recipients. Despite a waning effect, antibody levels remained high at 6 months and adverse events were rare. Clinical Trials Registration . NCT04805125.
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Potential conflicts of interest. B. S. and M. B. received unrestricted grants from Moderna (2021/2022) for the conduct of the COVERALL-2 and COVERALL-3 study. H. C. B. has received in the 36 months prior to the submission of this manuscript 1 grant from Gilead that was not related to this project; has served as the president of the Association Contre le HIV et Autres Infections Transmissibles until June 2022; and in this role he had received support for the Swiss HIV Cohort Study from ViiV Healthcare, Gilead, BMS, and MSD. A. T. received unrestricted research funding from the Swiss National Science Foundation, the Swiss HIV Cohort Study, Gilead Sciences, and Novartis, not related to this study. D. L. B. received honoraria for advisory boards from Gilead, MSD, Pfizer, AstraZeneca, and ViiV, outside of the study. I. A. received travel and research grants from Gilead; and honoraria as part of advisory board member for Moderna, outside of this study. H. F. G., outside of this study, reports grants from the Swiss National Science Foundation, National Institutes of Health (NIH), and the Swiss HIV Cohort Study; unrestricted research grants from the Bill and Melinda Gates Foundation, Gilead Sciences, ViiV Healthcare, and Yvonne Jacob Foundation; personal fees from consulting or advisory boards or data safety monitoring boards for Merck, Gilead Sciences, ViiV Healthcare, Janssen, Johnson and Johnson, GSK, and Novartis; and his institution received money for participation in the following clinical COVID-19 studies: 540-7773/5774 (Gilead), TICO (ACTIV-3, INSIGHT/NIH), and the Morningsky study (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 outside the submitted work. D. L. B. reports honoraria for advisory boards, lectures, and travel grants from Gilead, MSDV, and ViiV, outside this work. N. J. M. reports honoraria for advisory boards and travel grants from Gilead, Biotest, and Takeda, outside of this work. R. D. K. reports grants from the Swiss National Science Foundation, NIH, the Swiss HIV Cohort Study, and Gilead Sciences, all outside of this study. All other authors report no potential conflicts.
All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
ISSN:1537-6613
0022-1899
1537-6613
DOI:10.1093/infdis/jiae291