Immune response to third SARS‐CoV‐2 vaccination in seronegative kidney transplant recipients: Possible improvement by mycophenolate mofetil reduction
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Abstract
Modification of vaccination strategies is necessary to improve the immune response to SARS‐CoV‐2 vaccination in kidney transplant recipients (KTRs). This multicenter observational study analyzed the effects of the third SARS‐CoV‐2 vaccination in previously seronegative KTRs with the focus on temporary mycophenolate mofetil (MMF) dose reduction within propensity matched KTRs. 56 out of 174 (32%) previously seronegative KTRs became seropositive after the third vaccination with only three KTRs developing neutralizing antibodies against the omicron variant. Multivariate logistic regression revealed that initial antibody levels, graft function, time after transplantation and MMF trough levels had an influence on seroconversion ( P < .05). After controlling for confounders, the effect of MMF dose reduction before the third vaccination was calculated using propensity score matching. KTRs with a dose reduction of ≥33% showed a significant decrease in MMF trough levels to 1.8 (1.2–2.5) μg/ml and were more likely to seroconvert than matched controls ( P = .02). Therefore, a MMF dose reduction of 33% or more before vaccination is a promising approach to improve success of SARS‐CoV‐2 vaccination in KTRs.
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SciScore for 10.1101/2022.01.18.22269420: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: KTRs included in the study had to be older than 18 years, without previous COVID-19 infection, and able to give informed consent for participation.
IRB: The study was approved by the ethics committee of the Medical Faculty at the Heinrich-Heine University, Düsseldorf, Germany (study number 2020-1237) and in line with the Declaration of Helsinki, as revised in 2013.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Evaluation of humoral response: All samples were tested for IgG antibodies against SARS-CoV-2 spike S1 subunit using Anti-SARS-CoV-2-QuantiVac-ELISA (Euroimmun … SciScore for 10.1101/2022.01.18.22269420: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: KTRs included in the study had to be older than 18 years, without previous COVID-19 infection, and able to give informed consent for participation.
IRB: The study was approved by the ethics committee of the Medical Faculty at the Heinrich-Heine University, Düsseldorf, Germany (study number 2020-1237) and in line with the Declaration of Helsinki, as revised in 2013.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Evaluation of humoral response: All samples were tested for IgG antibodies against SARS-CoV-2 spike S1 subunit using Anti-SARS-CoV-2-QuantiVac-ELISA (Euroimmun AG, Lübeck, Germany) as well as for SARS-CoV-2 neutralization efficacy (NT) in a BSL-3 facility at the Institute of Virology, University Hospital Düsseldorf, Germany Anti-SARS-CoV-2-QuantiVac-ELISAsuggested: NoneIn addition to antibody level measurement, neutralizing capacity of the Anti-SARS-CoV-2 antibodies against was evaluated. Anti-SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Data Analysis: Statistical analysis was performed using SPSS version 23 (SPSS Inc., Chicago, USA) and Graph Prism 9 (GraphPad Software, San Diego, USA). SPSSsuggested: (SPSS, RRID:SCR_002865)GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)Results 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:There are some limitations of the present study. We have performed two follow-up visits. More frequent visits may resolve antibody waning more precisely. In addition, we cannot exclude a bias in the process of MMF reduction. Each decision was made by the treating nephrologist after contacting the transplantation center considering each case individually. Another relevant point is that our MMF reduction group was relatively small with different categories of dose reduction. Finally, we only studied humoral immune responses and it is unclear if cellular immunity against SARS-CoV-2 follows the same pattern in KTRs. In summary, we showed that KTRs have antibody kinetics similar to the general population. However, these patients develop lower antibody levels, which is the main reason for shorter humoral protection. In addition, the third vaccination against SARS-CoV-2 leads to seroconversion in 32.1% in previously seronegative patients. This is a substantial achievement, however many KTRs are still insufficiently protected. Our results suggest that a moderate, temporary MMF dose reduction could be a safe approach to improve vaccination success in KTRs.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04743947 Recruiting Vaccination Against COVID-19 in Chronic Kidney Disease 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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