Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1–2, dose-ranging study
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SciScore for 10.1101/2021.01.19.20248611: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The protocol and amendments were approved by applicable Independent Ethics Committees/Institutional Review Boards and the regulatory agency as per local regulations.
Consent: Informed consent was obtained from the participants before any study procedures were performed.Randomization Groups were randomly assigned using an interactive response technology system. Blinding not detected. Power Analysis not detected. Sex as a biological variable Exclusion criteria included chronic illness or medical conditions considered to potentially increase the risk for severe Covid-19 illness; women who were pregnant or lactating; women of childbearing potential who were not using … SciScore for 10.1101/2021.01.19.20248611: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The protocol and amendments were approved by applicable Independent Ethics Committees/Institutional Review Boards and the regulatory agency as per local regulations.
Consent: Informed consent was obtained from the participants before any study procedures were performed.Randomization Groups were randomly assigned using an interactive response technology system. Blinding not detected. Power Analysis not detected. Sex as a biological variable Exclusion criteria included chronic illness or medical conditions considered to potentially increase the risk for severe Covid-19 illness; women who were pregnant or lactating; women of childbearing potential who were not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination; participation, or planned participation, in another clinical trial during the study period; receipt or planned receipt of any vaccine in the 30 days before the first or up to 30 days following the last study vaccination (except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines); receipt of immunoglobulins, blood or blood-derived products in the past 3 months; and active or prior documented autoimmune disease. Table 2: Resources
Antibodies Sentences Resources Individuals testing negative for SARS-CoV-2 antibodies were included in the study. SARS-CoV-2suggested: NoneSupplementary Methods), in which the reference standard was human serum with known concentration of anti-S protein IgG antibodies; quantitative results were reported in ELISA Units (EU)/mL. anti-S protein IgGsuggested: NoneFold-rises in serum antibody neutralisation titre post-vaccination relative to D1 were calculated, whereby pre-vaccination titres below the lower limit of quantification (LLOQ) were converted to LLOQ/2. D1suggested: NoneNeutralising antibody seroconversion was defined as baseline values below the LLOQ with detectable neutralisation titres above assay LLOQ at D22 and D36. D36suggested: NoneResults from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The main limitation of this study was the erroneous characterisation of the content of protein and HCPs used in the filled clinical materials administered in the trial, resulting in a significantly lower concentration of SARS-CoV-2 S protein in the formulated vaccine product than expected, and a correspondingly higher HCP content. Other limitations included the necessarily limited numbers of participants in this Phase I/II study, thus rare SAEs and AESIs may not have been captured. Cellular profiling would also be required to define the source of cytokines detected during ex vivo whole blood stimulation. The results from the candidate vaccine formulations tested here are informative in terms of the neutralising and binding antibody responses generated in healthy adults. Further improvement of the preS vaccine antigen formulation is needed in order to be able to identify the optimal vaccine dose for larger scale Phase III development.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04537208 Active, not recruiting Study of Recombinant Protein Vaccine Formulations Against CO… NCT04450004 Active, not recruiting Safety, Tolerability and Immunogenicinity of a Coronavirus-L… 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.
- No protocol registration statement was detected.
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