Serological Responses to the First Three Doses of SARS-CoV-2 Vaccination in Inflammatory Bowel Disease: A Prospective Cohort Study
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Abstract
Individuals with inflammatory bowel disease (IBD) who are immunocompromised may have a reduced serological response to the SARS-CoV-2 vaccine. We investigated serological responses following 1 st , 2 nd , and 3 rd doses of SARS-CoV-2 vaccination in those with IBD.
Methods
A prospective cohort study of persons with IBD ( n = 496) assessed serological response 1–8 weeks after 1 st dose vaccination, 1–8 weeks after 2 nd dose, 8 or more weeks after 2 nd dose, and at least 1 week after 3 rd dose. Seroconversion and geometric mean titer (GMT) with 95% confidence intervals (CI) were assessed for antibodies to the SARS-CoV-2 spike protein. Multivariable linear regression models assessed the adjusted fold change (FC) in antibody levels.
Results
Seroconversion and GMT increased from post-1 st dose to 1–8 weeks post-2 nd dose (81.6%, 1814 AU/mL vs. 98.7%, 9229 AU/mL, p <0.001), decreased after 8 weeks post-2 nd dose (94.9%, 3002 AU/mL, p <0.001), and rebounded post-3 rd dose (99.6%, 14639 AU/mL, p <0.001). Prednisone was the only IBD-related medication associated with diminished antibody response after 3 rd -dose vaccination (FC: 0.07 [95% CI: 0.02, 0.20]). Antibody levels steadily decline following the 2 nd (FC: 0.92 [95% CI: 0.90, 0.94] per week) and 3 rd dose (FC: 0.88 [95% CI: 0.84, 0.92] per week) of the SARS-CoV-2 vaccine.
Conclusion
A three-dose regimen of vaccination to SARS-CoV-2 yields a robust antibody response for those with IBD across all classes of IBD therapies except for prednisone. The decaying antibody levels following the 3 rd dose of the vaccine should be monitored in future studies.
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SciScore for 10.1101/2022.03.16.22272440: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants provided informed consent, and the study was approved by the University of Calgary’s Conjoint Health Research Ethics Board (REB20-1082).
IRB: All participants provided informed consent, and the study was approved by the University of Calgary’s Conjoint Health Research Ethics Board (REB20-1082).Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Nucleocapsid antibody levels were assessed for serosurveillance of natural infection to SARS-CoV-2 with seroconversion defined as an anti-N antibody concentration of ≥0.7 signal/cutoff index. anti-Nsuggested: None15 … SciScore for 10.1101/2022.03.16.22272440: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants provided informed consent, and the study was approved by the University of Calgary’s Conjoint Health Research Ethics Board (REB20-1082).
IRB: All participants provided informed consent, and the study was approved by the University of Calgary’s Conjoint Health Research Ethics Board (REB20-1082).Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Nucleocapsid antibody levels were assessed for serosurveillance of natural infection to SARS-CoV-2 with seroconversion defined as an anti-N antibody concentration of ≥0.7 signal/cutoff index. anti-Nsuggested: None15 The sensitivity and specificity of the SARS-CoV-2 IgG II Quant assay was 98.1% and 99.6%, respectively.16 Additionally, antibody levels are reported in the World Health Organization binding antibody units (BAU) to allow for comparison across assays.17,18 Serum samples were drawn for assessment of anti-S and anti-N antibodies to SARS-CoV-2 following the 1st, 2nd, and/or 3rd dose of a SARS-CoV-2 vaccine. anti-Ssuggested: NoneMean within-individual differences in antibody concentration were calculated for each subset and stratified by prior infection to SARS-CoV-2. SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Antibodies to the RBD of the S1 subunit of the spike protein (anti-S) were assessed using the Abbott Architect SARS-CoV-2 IgG II Quant assay (Abbott, Abbott Park, Illinois, USA). Abbott Architectsuggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)Abbottsuggested: (Abbott, RRID:SCR_010477)Statistics: Statistical analyses were performed using STATA v. STATAsuggested: (Stata, RRID:SCR_012763)0 (StataCorp) with a significance threshold of 0.05 and two-sided testing. StataCorpsuggested: (Stata, RRID:SCR_012763)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:Several limitations of our study should be considered. Due to a low number of patients with breakthrough COVID-19 infections, we were unable to assess the effectiveness of SARS-CoV-2 vaccination or evaluate whether antibody titres were associated with breakthrough infections. In addition, we did not assess other immune responses to SARS-CoV-2 vaccination, including neutralizing antibodies or T-cell immunity, which may serve as more functional proxies of immune protection over antibody titres.24,29 Due to logistical constraints in data collection during the pandemic, we were unable to obtain samples corresponding to all vaccine doses for all patients, resulting in semi-independent vaccine dose groups. While a community-based recruitment strategy involving all gastroenterologists in the Calgary zone was utilized, population-based sampling was not possible. Further, we did not compare those with IBD to healthy controls; however, a recent serology study performed in the general population within the same jurisdiction and using the same antibody assay demonstrated higher antibodies than our IBD population after 1st and 2nd dose of the vaccine.30 We used the Abbott Architect SARS-CoV-2 IgG II Quant assay, but also converted antibody levels to the World Health Organization BAU/ml (Supplementary Table 4) to support standardization across assays.17,18 Timing and type of vaccination was variable due to changing vaccine availability in Canada. We conducted a sensitivity analysis compari...
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.
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- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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