Quantifying the Vaccine-Induced Humoral Immune Response to Spike-Receptor Binding Domain as a Surrogate for Neutralization Testing Following mRNA-1273 (Spikevax) Vaccination Against COVID-19
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SciScore for 10.1101/2022.03.09.22271896: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Informed written consent was originally obtained from all study participants in the context of the associated vaccine phase 2 study and the study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines.
IRB: Approval was granted by the regulatory and institutional committees for the phase 2 trial [26] and the diagnostic protocol under which the existing samples were tested.Sex as a biological variable not detected. Randomization In brief, healthy participants aged ≥18 years in two age cohorts (aged 18-54 years and aged ≥55 years) were randomized 1:1:1 to receive 50 μg or 100 μg of mRNA-1273 or placebo. Blinding not detected. Pow… SciScore for 10.1101/2022.03.09.22271896: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Informed written consent was originally obtained from all study participants in the context of the associated vaccine phase 2 study and the study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines.
IRB: Approval was granted by the regulatory and institutional committees for the phase 2 trial [26] and the diagnostic protocol under which the existing samples were tested.Sex as a biological variable not detected. Randomization In brief, healthy participants aged ≥18 years in two age cohorts (aged 18-54 years and aged ≥55 years) were randomized 1:1:1 to receive 50 μg or 100 μg of mRNA-1273 or placebo. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources In brief, samples were quantified for SARS-CoV-2 RBD antibodies with a measuring range of 0.4-25,000 U/mL The assigned U/mL are equivalent to Binding Antibody Units (BAU)/mL as defined by the first World Health Organization (WHO) International Standard for anti-SARS-CoV-2 immunoglobulin (NIBSC code 20/136). anti-SARS-CoV-2 immunoglobulinsuggested: NoneAll outliers were associated with inconsistent patterns of antibody titers, most likely originating from sample mis assignments rather than biological or technical effects. 2.2.2. Elecsys Anti-SARS-CoV-2 (ACOV2N) immunoassay: In addition to the quantification of RBD-specific antibody titers induced by mRNA-1273 vaccination, all samples were assessed on the same cobas e 602 module with the ACOV2N assay [24]. Anti-SARS-CoV-2suggested: NoneFor each age category and dosage group, ACOV2S-measured anti-RBD antibody levels are shown as line plots and boxplots (log-scale) for every measurement time point. anti-RBDsuggested: 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:MN50 titers also somewhat reflected age dependency, however, the limitations of the MN50 method hampered systematic comparisons, especially at later visits (Days 43 and 57). Concordance was also observed between the ACOV2S and live MN50 assays for the samples from participants with a native SARS-CoV-2 infection. This indicates that levels of RBD antibodies are reflective of neutralizing activity irrespective of whether the immune response is induced by infection or vaccination. Consistent with the impact on the ACOV2S results, there is a tendency for participants who had both natural infection and vaccination with mRNA-1273 to have higher MN50 values. Overall, the differences in dynamic range and lack of standardization of the MN50 assay suggest that the ACOV2S assay is better suited to study the differences across the whole antibody concentration range and all visits. Overall, these findings are consistent with a previous analysis of ACOV2S values in subjects vaccinated with mRNA-1273 [25] and suggest that ACOV2S-measured antibody levels correlate well with the presence of neutralizing antibodies after vaccination. Combining the high throughput, automated ACOV2S and ACOV2N assays enables stratification of naïve from preinfected individuals and monitoring for concomitant or breakthrough infection. ACOV2S enables reliable quantification of the humoral immune response to vaccination. Furthermore, the observed high titers are in general indicative of convincing in vitro neutrali...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04405076 Completed Dose-Confirmation Study to Evaluate the Safety, Reactogenici… 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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