Evaluation of safety and immunogenicity of receptor-binding domain-based COVID-19 vaccine (Corbevax) to select the optimum formulation in open-label, multicentre, and randomised phase-1/2 and phase-2 clinical trials
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SciScore for 10.1101/2022.03.08.22271822: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The Investigational Review Board or Ethics Committee at each study site approved the protocol.
Consent: Written informed consents were obtained from all healthy volunteers prior to the enrollment.Sex as a biological variable Eligible participants were healthy men and women aged 18-65 years at the time of 1st vaccination for Phase-1/2 and Phase-2 studies. Randomization Studies are prospective, open-label, randomized (phase-1/2) to assess best vaccine formulation based on safety, tolerability, reactogenicity and immunogenicity in Covid-19 RT-PCR and sero-negative subjects. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources They had to be negative to … SciScore for 10.1101/2022.03.08.22271822: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The Investigational Review Board or Ethics Committee at each study site approved the protocol.
Consent: Written informed consents were obtained from all healthy volunteers prior to the enrollment.Sex as a biological variable Eligible participants were healthy men and women aged 18-65 years at the time of 1st vaccination for Phase-1/2 and Phase-2 studies. Randomization Studies are prospective, open-label, randomized (phase-1/2) to assess best vaccine formulation based on safety, tolerability, reactogenicity and immunogenicity in Covid-19 RT-PCR and sero-negative subjects. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources They had to be negative to SARS-CoV-2 infection and anti-SARS-CoV-2 antibody prior to enrolment. anti-SARS-CoV-2suggested: NoneAnti-RBD antibody responses and IgG-subclass responses were measured using validated ELISA-method. Anti-RBDsuggested: NoneSoftware and Algorithms Sentences Resources All the statistical analyses were conducted using SAS® 9.4 or higher (SAS Institute, Cary NC). SAS®suggested: (SASqPCR, RRID:SCR_003056)SAS Institutesuggested: (Statistical Analysis System, RRID:SCR_008567)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
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.
Results from scite Reference Check: We found no unreliable references.
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