Longitudinal SARS-CoV-2 neutralization of Omicron BA.1, BA.5 and BQ.1.1 after four vaccinations and the impact of break-through infections in hemodialysis patients

Abstract

Background Individuals on hemodialysis are more vulnerable to SARS-CoV-2 infection than the general population due to end-stage kidney disease-induced immunosuppression. Methods 26 hemodialysis patients experiencing SARS-CoV-2 infection after 3rd vaccination were matched 1:1 to 26 out of 92 SARS-CoV-2 naives by age, sex, dialysis vintage and immunosuppressive drugs receiving a 4th vaccination with an mRNA-based vaccine. A competitive surrogate neutralization assay was used to monitor vaccination success. To determine infection neutralization titers, Vero-E6 cells were infected with SARS-CoV-2 variants of concern (VoC), Omicron sub-lineage BA.1, BA.5, and BQ.1.1. 50% inhibitory concentration (IC50, serum dilution factor 1:x) was determined before, four weeks after and 6 months after the 4th vaccination. Results 52 hemodialysis patients received four COVID-19 vaccinations and were followed up for a median of 6.3 months. Patient characteristics did not differ between the matched cohorts. Patients without a SARS-CoV-2 infection had a significant reduction of real virus neutralization capacity for all Omicron sub-lineages after six months (p<0.001 each). Those patients with a virus infection did not experience a reduction of real virus neutralization capacity after six months. Compared to the other Omicron VoC the BQ.1.1 sub-lineage had the lowest virus neutralization capacity. Conclusions SARS-CoV-2-naive hemodialysis patients had significantly decreased virus neutralization capacity six months after the 4th vaccination whereas patients with a SARS-CoV-2 infection had no change in neutralization capacity. This was independent of age, sex, dialysis vintage and immunosuppression. Therefore, in infection-naive hemodialysis patients a fifth COVID-19 vaccination might be reasonable 6 months after the 4th vaccination.

Competing Interest Statement

The authors declare no conflict of interest. UP is receiving grants from Hoehnle AG, SCG Cell Therapy and VirBio and personal fees from Abbott, Abbvie, Arbutus, Gilead, GSK, J&J, Roche, Sanofi, Sobi and Vaccitech. UP is co-founder and share-holder of SCG Cell Therapy. OTK is receiving grants from Bay-VOC network and FOR-COVID network.

Funding Statement

UP is receiving grants from Hoehnle AG, SCG Cell Therapy and VirBio and personal fees from Abbott, Abbvie, Arbutus, Gilead, GSK, J&J, Roche, Sanofi, Sobi and Vaccitech. UP is co-founder and share-holder of SCG Cell Therapy. OTK is receiving grants from Bay-VOC network and FOR-COVID network.

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I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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Medical Ethics Committee of the Klinikum rechts der Isar of the Technical University of Munich gave ethical approval for this work. (ethic vote 163/21 S-SR, March 19th, 2021)

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Data Availability

The datasets for this manuscript are not publicly available because written informed consent did not include wording on data sharing (German data protection laws). Reasonable requests to access the datasets should be directed to the corresponding author.

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