Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial
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SciScore for 10.1101/2020.12.03.20243709: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study protocol was approved by the study centre Institutional Review Board and registered with ClinicalTrials.gov (identifier NCT04405908).
Consent: Inclusion criteria included being able to provide informed consent, having a BMI between 18·5 and 35·0 kg/m2, being able to understand and sign the informed consent and being available for the duration of the study (6 months).Randomization We report the interim analysis of the first stage of a phase 1 randomized, double-blind, placebo-controlled study of SCB-2019. Blinding All participants and personnel involved in safety data collection and immunogenicity assessments were blinded to the study treatment. Power … SciScore for 10.1101/2020.12.03.20243709: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study protocol was approved by the study centre Institutional Review Board and registered with ClinicalTrials.gov (identifier NCT04405908).
Consent: Inclusion criteria included being able to provide informed consent, having a BMI between 18·5 and 35·0 kg/m2, being able to understand and sign the informed consent and being available for the duration of the study (6 months).Randomization We report the interim analysis of the first stage of a phase 1 randomized, double-blind, placebo-controlled study of SCB-2019. Blinding All participants and personnel involved in safety data collection and immunogenicity assessments were blinded to the study treatment. Power Analysis not detected. Sex as a biological variable Female participants of childbearing potential were not to be pregnant or breastfeeding and had to agree to use protocol-approved forms of contraception until 6 months after the first vaccination. Table 2: Resources
Antibodies Sentences Resources The primary immunogenicity endpoint was based on the anti-SCB-2019 IgG antibody titre at each blood sampling timepoint, measured by ELISA. anti-SCB-2019 IgGsuggested: NoneSecondary immunogenicity assessments included an ACE2-competitive ELISA measuring the inhibition of SCB-2019 binding to human ACE2 receptor by serum antibodies, and anti-wild-type SARS-CoV-2 neutralising activity measured by wild-type microneutralisation assay (WT-MN50) anti-wild-type SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources All analyses, and summaries were on group unblinded data performed using SAS® software (version 9·4 or higher) or GraphPad Prism, v. SAS®suggested: (SASqPCR, RRID:SCR_003056)GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)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:These limitations are being addressed in the extension of the study. While we have compared the immune responses elicited by vaccination with those measured in the convalescent sera of patients with PCR-confirmed COVID-19 infection, in the absence of an established serologic correlate of protection we cannot extrapolate our data to infer protection. In conclusion we have demonstrated safety, good tolerability and high neutralising immune responses with a Th1-biased cellular immune response that supports the further development of both candidate vaccines including assessment of the protective efficacy.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04405908 Active, not recruiting SCB-2019 as COVID-19 Vaccine 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.
- Thank you for including a protocol registration statement.
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