Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNFα
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SciScore for 10.1101/2021.08.22.21262263: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants signed an informed consent form before any study procedure. Sex as a biological variable Patients with past COVID-19 infection proved by SARS-CoV-2 polymerase-chain-reaction test and pregnant women were excluded. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Anti-TNFα drug levels and anti-TNFα antibodies were measured. anti-TNFαsuggested: (Beckman Coulter Cat# IM3279U, RRID:AB_2892136)Outcomes: The primary endpoint was seropositivity rate and magnitude of the immune response (levels of binding IgG antibodies to SARS-CoV-2 spike (S) antigen and neutralizing … SciScore for 10.1101/2021.08.22.21262263: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants signed an informed consent form before any study procedure. Sex as a biological variable Patients with past COVID-19 infection proved by SARS-CoV-2 polymerase-chain-reaction test and pregnant women were excluded. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Anti-TNFα drug levels and anti-TNFα antibodies were measured. anti-TNFαsuggested: (Beckman Coulter Cat# IM3279U, RRID:AB_2892136)Outcomes: The primary endpoint was seropositivity rate and magnitude of the immune response (levels of binding IgG antibodies to SARS-CoV-2 spike (S) antigen and neutralizing and inhibitory antibodies functionality) following BNT162b2 in patients with IBD with or without anti-TNFα treatment, or HC, at V3. binding IgGsuggested: Noneanti-TNFα treatment ,suggested: NoneAnti-TNFα drug and anti-drug antibody levels were assessed for adalimumab (ADA and ADA-Abs) and infliximab (IFX and IFX-Abs) using Lisa-Tracker ELISA in accordance with manufacturer’s instructions (Theradiag, Beaubourg, France). anti-drugsuggested: NoneAnti-S antibody concentrations are expressed as geometric mean concentrations (GMCs) with 95% confidence intervals (CI). Anti-Ssuggested: NoneExperimental Models: Cell Lines Sentences Resources Preparation of SARS-CoV-2-spike pseudoparticles and neutralization assay: To generate SARS-CoV-2 pseudo typed vesicular stomatitis virus (VSV) particles, human embryonic kidney (HEK)-293T cells were grown to 70% confluence in Dulbecco’s modified eagle medium (DMEM) supplemented in 10% fetal bovine serum (FBS), 1% L-glutamine, and 1% penicillin streptavidin. HEK)-293Tsuggested: NoneHEK-293 cells stably expressing human ACE2 were cultured in DMEM (Biological Industries, Beit Haemek, Israel) supplemented in 10% FBS, 1% L-glutamine, and 1% penicillin streptavidin. HEK-293suggested: NoneRecombinant DNA Sentences Resources Cells were transfected with pCMV3 plasmid encoding the SARS-CoV-2 S protein with C-terminal, 19 residues truncation (pCMV3-SARS-CoV-2-SΔ19) using polyethylenimine (PEI). pCMV3suggested: RRID:Addgene_161029)pCMV3-SARS-CoV-2-SΔ19suggested: NoneSoftware and Algorithms Sentences Resources SARS-CoV-2 IgG II quantitative testing was performed using the Abbott architect i2000sr platform in accordance with manufacturer’s instructions23. Abbottsuggested: (Abbott, RRID:SCR_010477)Statistical Analysis: Data were collected in secured web-based platform (REDCap) and analyzed using SPSS version 27 (IBM, New York, United States). REDCapsuggested: (REDCap, RRID:SCR_003445)SPSSsuggested: (SPSS, RRID:SCR_002865)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:Limitations include difference in gender ratio between IBD and HC groups at baseline, the relatively young age of participants (although this reflects typical IBD populations) and the use of only one vaccine type. Evaluation of vaccine efficacy is limited, as infection rate in Israel during the study period was low. Finally, observation was limited to 4 weeks after the second vaccine. To conclude, our study provides prospective, controlled evidence for the efficacy and safety of the COVID-19 BNT162b2 vaccine in patients with IBD stratified according to therapy. We demonstrate the dynamics of development of functional immune response and the factors causing impairment, specifically anti-TNFα therapy and older age. The lack of correlation with timing of anti-TNFα therapy or drug levels, enables important clinical guidance to patients and their caregivers. As immune response longevity in this group may be limited, vaccine booster dose should be considered. Long(er) term outcomes and the mechanism of decreased immune responses should be evaluated.
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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