Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study
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SciScore for 10.1101/2021.03.31.21254668: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The trial protocol and informed consent form were approved by the Taiwan Food and Drug Administration and the ethics committee at the site.
IRB: The trial protocol and informed consent form were approved by the Taiwan Food and Drug Administration and the ethics committee at the site.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
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 …SciScore for 10.1101/2021.03.31.21254668: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The trial protocol and informed consent form were approved by the Taiwan Food and Drug Administration and the ethics committee at the site.
IRB: The trial protocol and informed consent form were approved by the Taiwan Food and Drug Administration and the ethics committee at the site.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
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:This interim report has some limitations: small size of the trial, the short period of follow-up at this time point, and the participants’ young age and good health status. We were not able to assess the durability of the immune responses after Day 57 in this interim report. However, participants will be followed up for 6 months after the second vaccination with scheduled blood collections throughout that period to evaluate the humoral immunologic responses. Although the level of immunity needed to protect from COVID-19 remains unknown, NIBSC 20/130 standard serum was tested in terms of wild-type SARS-CoV-2 neutralizing antibody titer for the development and evaluation of serological assays for the detection of antibodies against SARS-CoV-2, as a positive control. These safety and immunogenicity findings support further advancement of the MVC-COV1901 vaccine to subsequent clinical trials. Of the three doses evaluated, both the MD and HD elicited high neutralizing antibody responses with all participants seroconverted after second vaccination. Further phase 2 trial with 3700 participants (including the populations at greatest risk for serious Covid-19 such as those with chronic medical diseases and older adults) is on-going (ClinicalTrials.gov number, NCT04695652)
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04487210 Active, not recruiting A Study to Evaluate the Safety and Immunogenicity of MVC-COV… NCT04695652 Active, not recruiting A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in … 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.
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