Longitudinal Analysis of Antibody Responses to the mRNA BNT162b2 Vaccine in Patients Undergoing Maintenance Hemodialysis: A 6-Month Follow-Up
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Abstract
Background: Patients on hemodialysis (HD) are at higher risk for COVID-19, overall are poor responders to vaccines, and were prioritized in the Portuguese vaccination campaign.
Objective: This work aimed at evaluating in HD patients the immunogenicity of BTN162b2 after the two doses induction phase, the persistence of specific antibodies along time, and factors predicting these outcomes.
Methods: We performed a prospective, 6-month long longitudinal cohort analysis of 156 HD patients scheduled to receive BTN162b2. ELISA quantified anti-spike IgG, IgM, and IgA levels in sera were collected every 3 weeks during the induction phase (t0 before vaccine; t1, d21 post first dose; and t2 d21 post second dose), and every 3–4 months during the waning phase (t3, d140, and t4, d180 post first dose). The age-matched control cohort was similarly analyzed from t0 to t2.
Results: Upon exclusion of participants identified as previously exposed to SARS-CoV-2, seroconversion at t1 was lower in patients than controls (29 and 50%, respectively, p = 0.0014), while the second vaccine dose served as a boost in both cohorts (91 and 95% positivity, respectively, at t2, p = 0.2463). Lower response in patients than controls at t1 was a singularity of the participants ≤ 70 years ( p = 2.01 × 10 −05 ), associated with immunosuppressive therapies ( p = 0.013), but not with lack of responsiveness to hepatitis B. Anti-spike IgG, IgM, and IgA levels decreased at t3, with IgG levels further waning at t4 and resulting in >30% seronegativity. Anti-spike IgG levels at t1 and t4 were correlated (ρ = 0.65, p < 2.2 × 10 −16 ).
Conclusions: While most HD patients seroconvert upon 2 doses of BNT162b2 vaccination, anti-spike antibodies levels wane over the following 4 months, leading to early seroreversion in a sizeable fraction of the patients. These findings warrant close monitoring of COVID-19 infection in vaccinated HD patients, and advocate for further studies following reinforced vaccination schedules.
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SciScore for 10.1101/2021.07.20.21260849: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: ETHICS STATEMENT: This study was approved by the Ethics committee of Davita in Portugal in compliance with the Declaration of Helsinki, and follows international and national guidelines for health data protection.
Consent: All participants provided informed consent to take part in the study.Sex as a biological variable not detected. Randomization An age-matched control cohort without kidney disease comprised 143 individuals randomly selected from a larger cohort of 1245 Health care workers and 146 nursing home residents (8). Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources ANTIBODY MEASUREMENTS: The ELISA assay used to quantify IgG, IgM and IgA … SciScore for 10.1101/2021.07.20.21260849: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: ETHICS STATEMENT: This study was approved by the Ethics committee of Davita in Portugal in compliance with the Declaration of Helsinki, and follows international and national guidelines for health data protection.
Consent: All participants provided informed consent to take part in the study.Sex as a biological variable not detected. Randomization An age-matched control cohort without kidney disease comprised 143 individuals randomly selected from a larger cohort of 1245 Health care workers and 146 nursing home residents (8). Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources ANTIBODY MEASUREMENTS: The ELISA assay used to quantify IgG, IgM and IgA anti-full-length SARSCoV2 spike was adapted from (9) and semi-automized in a 384-well format, according to a protocol to be detailed elsewhere. anti-full-lengthsuggested: NoneAntibodies against SARS-Cov-2 N antigen were measured by an electrochemiluminescence immunoassay (ECLIA), from Roche Diagnostics (Elecsys® Anti-SARS-CoV-2) and total IgG, IgM and IgA at t2 were quantified using three immunoturbidimetric methods (PEG enhanced) from Siemens Healthineers, using Siemens Atellica CH Analyzer, following manufacturer instructions. SARS-Cov-2 N antigensuggested: NoneSARS-Cov-2 Nsuggested: NoneAnti-SARS-CoV-2suggested: Nonetotal IgGsuggested: NoneSoftware and Algorithms Sentences Resources ANTIBODY MEASUREMENTS: The ELISA assay used to quantify IgG, IgM and IgA anti-full-length SARSCoV2 spike was adapted from (9) and semi-automized in a 384-well format, according to a protocol to be detailed elsewhere. ANTIBODYsuggested: (Antibodypedia, RRID:SCR_012782)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.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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