Humoral and cellular responses to mRNA vaccines against SARS-CoV-2 in patients with a history of CD20 B-cell-depleting therapy (RituxiVac): an investigator-initiated, single-centre, open-label study
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SciScore for 10.1101/2021.07.04.21259848: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was approved by the local ethics committee of the Canton of Bern, Switzerland (ID 2021-00669) and was registered on clinicaltrials.gov (Identifier: NCT04877496).
Consent: The trial was performed in accordance with the principles of the Declaration of Helsinki, and all participants provided written informed consent prior to inclusion.Sex as a biological variable Individuals younger than 18 years of age and pregnant or lactating women were not eligible to participate. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources All study participants were tested for the presence of anti-nucleocapsid antibodies. ant…SciScore for 10.1101/2021.07.04.21259848: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was approved by the local ethics committee of the Canton of Bern, Switzerland (ID 2021-00669) and was registered on clinicaltrials.gov (Identifier: NCT04877496).
Consent: The trial was performed in accordance with the principles of the Declaration of Helsinki, and all participants provided written informed consent prior to inclusion.Sex as a biological variable Individuals younger than 18 years of age and pregnant or lactating women were not eligible to participate. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources All study participants were tested for the presence of anti-nucleocapsid antibodies. anti-nucleocapsidsuggested: NoneCreatinine values, lymphocyte subpopulation counts, and total immunoglobulin quantities (IgG, IgM, IgA) were obtained using the routine clinical analytical services of the Center of Laboratory Medicine, Department of Clinical Chemistry of University Hospital Bern. anti-SARS-CoV2 S1-IgG and NC-IgG responses to vaccines: To assess humoral responses to vaccines, IgG antibodies targeting the SARS-CoV2 S1 protein, were detected using a commercial ELISA test from Euroimmun AG, Lübeck, Germany, as previously described 23. total immunoglobulin quantities (IgGsuggested: Noneanti-SARS-CoV2suggested: NoneS1-IgGsuggested: NoneIgGsuggested: NoneSARS-CoV2 S1 protein,suggested: NoneAfter three washing steps, 100μl of HRP-labelled secondary anti-human IgG antibodies was added for 30 minutes at 37°C, followed by three more washing steps. anti-human IgGsuggested: 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:The present study has limitations. First, we could not measure anti-SARS-CoV2 spike protein antibodies before vaccination, because the Swiss vaccination program accelerated in high-risk individuals before recruitment was initiated. Therefore, we measured currently circulating anti-SARS-CoV2 nucleocapsid antibodies and excluded the three participants with detectable anti-nucleocapsid antibodies. Second, the distribution of vaccines manufactured by Pfizer-BioNTech and Moderna was not identical between controls and patients. Comirnaty® was the earliest approved vaccine in Switzerland that was made primarily available for individuals at high risk for severe COVID19. By the time when health care professionals and the general population became eligible for SARS-COV2 vaccination, Moderna® constituted the largest share of vaccines delivered to Switzerland. Finally, the current study population was highly heterogeneous regarding the underlying diseases, indications for CD20 depletion treatment, and immunosuppressive co-medication. However, this complex study population represents a real-world scenario and provided a unique opportunity to explore routine laboratory parameters that are readily available and could be used to predict vaccination efficacy and therefore guide vaccination timing despite the complexity of the various immunosuppressive regimens. Based on the current data, we propose that a simple peripheral count of CD4+ cells could serve as a starting point to stratify patien...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04877496 Recruiting Responses to COVID19 Vaccination in Patients With a Treatmen… 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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