Antinucleocapsid Antibodies After SARS-CoV-2 Infection in the Blinded Phase of the Randomized, Placebo-Controlled mRNA-1273 COVID-19 Vaccine Efficacy Clinical Trial
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
Abstract
No abstract available
Article activity feed
-
-
SciScore for 10.1101/2022.04.18.22271936: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization Participants were randomized 1:1 to two 100 μg doses of mRNA-1273 vaccine or placebo, given at Day 1 (baseline) and Day 29. Blinding This analysis is based on data through the completion of the blinded phase of the study with a data cutoff date of March 26, 2021. eFigure 1 depicts the flow of participants with detected SARS-CoV-2 infection from enrollment through to inclusion in the analysis. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources A Wilcoxon rank sum test was used to compare anti-spike antibody responses between those anti-N seropositive and seronegative at the PDV. anti-spikesuggested: Noneanti…SciScore for 10.1101/2022.04.18.22271936: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization Participants were randomized 1:1 to two 100 μg doses of mRNA-1273 vaccine or placebo, given at Day 1 (baseline) and Day 29. Blinding This analysis is based on data through the completion of the blinded phase of the study with a data cutoff date of March 26, 2021. eFigure 1 depicts the flow of participants with detected SARS-CoV-2 infection from enrollment through to inclusion in the analysis. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources A Wilcoxon rank sum test was used to compare anti-spike antibody responses between those anti-N seropositive and seronegative at the PDV. anti-spikesuggested: Noneanti-Nsuggested: 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:This analysis has a few limitations. First, our participants received exclusively mRNA-1273 vaccine. It is unknown if vaccination with BNT162b2 or Ad26.COV2.S interferes with anti-N seropositivity post infection to the same magnitude as mRNA-1273. In a study of 31 individuals, the majority of whom received BNT162b2, and then became infected with SARS-CoV-2, anti-N Ab were detected in 68% at 5 weeks post infection using ELISA.35 Second, we only used the Elecsys assay, which has some of the highest sensitivity and specificity data, and it is unknown if other immunoassays will have different sensitivity at detecting recent or past infections in vaccinated persons. Third, our sample size is small with 52 fully-vaccinated persons with breakthrough Covid-19 assessed for seroconversion a median of 53 days post-diagnosis; thus transient anti-N seropositivity events could go undetected. However, the close follow up and uniformity in obtaining the swabs and serum samples increase confidence in and interpretability of our findings. Fourth, SARS-CoV-2 infections post vaccination that are caused by the delta and omicron variants have been associated with higher viral copy number upon diagnosis and more rapid clearance.36,37 Whether breakthrough infections due to these variants is associated with different rates of seroconversion cannot be ascertained using these data. Finally, this analysis was not addressing a pre-specified objective of the COVE study. While the statistical analysis plan...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04470427 Active, not recruiting A Study to Evaluate Efficacy, Safety, and Immunogenicity of … 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.
-
