A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity
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SciScore for 10.1101/2021.10.04.21264522: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical considerations: The Cuban Ministry of Public Health (MINSAP), the Independent Ethics Committee (IEC) for Studies on Human Subjects, at CENATOX and the Cuban National Regulatory Agency (Centre for State Control of Medicines and Medical Devices, CECMED), approved the trial and the procedures (CECMED, Authorization date: 13/10/2020, Reference number: 05.013.20BA).
Consent: Written informed consent was obtained from all volunteers.Sex as a biological variable Sixty Cuban volunteers aged 19-59 years, with body mass index 18.5-29.9 kg/m2, of both sexes, were recruited (Table 1). Randomization Study design and participants: This phase I, randomized, double-blind clinical trial was … SciScore for 10.1101/2021.10.04.21264522: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical considerations: The Cuban Ministry of Public Health (MINSAP), the Independent Ethics Committee (IEC) for Studies on Human Subjects, at CENATOX and the Cuban National Regulatory Agency (Centre for State Control of Medicines and Medical Devices, CECMED), approved the trial and the procedures (CECMED, Authorization date: 13/10/2020, Reference number: 05.013.20BA).
Consent: Written informed consent was obtained from all volunteers.Sex as a biological variable Sixty Cuban volunteers aged 19-59 years, with body mass index 18.5-29.9 kg/m2, of both sexes, were recruited (Table 1). Randomization Study design and participants: This phase I, randomized, double-blind clinical trial was carried out at the National Centre of Toxicology (CENATOX) in Havana, Cuba. Blinding Randomization and blinding: Stratified random blinded sampling was used to select the sample of the universe of Cuban citizens aged 19-59 years, which was proportionally divided in two age subgroups: 19-39 and 40-59 years to ensure a proper representation of each age subgroup. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Exclusion criteria were: history of COVID-19, SARS-CoV-2 PCR-positive tests or detection of antibodies anti-SARS-CoV-2, any severe disease or decompensated chronic disease, immunodeficiency, history of serious allergy, pregnancy, breastfeeding, and immunological treatment during the last 30 days. anti-SARS-CoV-2suggested: NoneSeroconversion rates for IgG anti-RBD antibodies (≥4-fold increase in antibody titres over pre-immunization titres) were calculated for each subject. anti-RBDsuggested: NoneExperimental Models: Cell Lines Sentences Resources sequence: 319-541 amino acid residues with a poly-histidine fusion tag at its C-terminus), expressed in CHO cells. CHOsuggested: CLS Cat# 603479/p746_CHO, RRID:CVCL_0213)Software and Algorithms Sentences Resources Statistical analyses were done using SPSS version 25·0; EPIDAT version 4.1, SPSSsuggested: (SPSS, RRID:SCR_002865), Prism GraphPad version 6.0. Prismsuggested: (PRISM, RRID:SCR_005375)GraphPadsuggested: (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: 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.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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