Declining Course of Humoral Immune Response in Initially Responding Kidney Transplant Recipients after Repeated SARS-CoV-2 Vaccination
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Abstract
The immunogenicity of SARS-CoV-2 vaccines in kidney transplant recipients is limited, resulting in inadequately low serological response rates and low immunoglobulin (Ig) levels, correlating with reduced protection against death and hospitalization from COVID-19. We retrospectively examined the time course of anti-SARS-CoV-2 Ig antibody levels after up to five repeated vaccinations in 644 previously nonresponding kidney transplant recipients. Using anti SARS-CoV-2 IgG/IgA ELISA and the total Ig ECLIA assays, we compared antibody levels at 1 month with levels at 2 and 4 months, respectively. Additionally, we correlated the measurements of the used assays. Between 1 and 2 months, and between 1 and 4 months, mean anti-SARS-CoV-2 Ig levels in responders decreased by 14% and 25%, respectively, depending on the assay. Absolute Ig values and time course of antibody levels showed high interindividual variability. Ig levels decreased by at least 20% in 77 of 148 paired samples with loss of sufficient serological protection over time occurring in 18 out of 148 (12.2%). IgG ELISA and total Ig ECLIA assays showed a strong positive correlation (Kendall’s tau = 0.78), yet the two assays determined divergent results in 99 of 751 (13.2%) measurements. IgG and IgA assays showed overall strong correlation but divergent results in 270 of 1.173 (23.0%) cases and only weak correlation of antibody levels in positive samples. Large interindividual variability and significant loss of serological response after 4 months supports repeated serological sampling and consideration of shorter vaccination intervals in kidney transplant recipients.
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SciScore for 10.1101/2022.03.29.22272858: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: We obtained written and informed consent into off-label use for vaccine doses four and five from all patients.
IRB: The institutional ethics committee of Charité – Universitätsmedizin Berlin approved this retrospective analysis (ethics votum EA1/030/22).Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Conversely, any positive SARS-CoV-2 RNA PCR, positive anti-SARS-CoV-2-N-protein antibodies, positive anti-SARS-CoV-2 Ig or administration of monoclonal anti-SARS-CoV-2-S-protein antibody therapy before the serological sample lead to exclusion of the respective following … SciScore for 10.1101/2022.03.29.22272858: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: We obtained written and informed consent into off-label use for vaccine doses four and five from all patients.
IRB: The institutional ethics committee of Charité – Universitätsmedizin Berlin approved this retrospective analysis (ethics votum EA1/030/22).Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Conversely, any positive SARS-CoV-2 RNA PCR, positive anti-SARS-CoV-2-N-protein antibodies, positive anti-SARS-CoV-2 Ig or administration of monoclonal anti-SARS-CoV-2-S-protein antibody therapy before the serological sample lead to exclusion of the respective following serological data. anti-SARS-CoV-2-N-proteinsuggested: Noneanti-SARS-CoV-2suggested: Noneanti-SARS-CoV-2-S-proteinsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Due to the study’s retrospective design, methodological limitations arise. However, the applied selection criteria for sample data account for the risk of selection bias. In a large number of patients at our institution, repeated serological measurements were not performed thus resulting in exclusion of singular samples. Hence, limiting the comparison of Ig levels between intervals to paired data samples decreased the size of the dataset but also reduces the risk selection bias due to singular samples that might not have been followed-up due to confounding reasons. Despite the limitations our analysis provides the first data of different assays and time course of the serological response in a large number of KTR.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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