A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial

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1. Version published to 10.1016/j.lana.2021.100079

   Dec 1, 2021
2. 

   ScreenIT

   Mar 15, 2021

   SciScore for 10.1101/2021.02.22.21252091: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The Independent Data Monitoring Committee and Independent Ethics Committee checked recruitment and vaccination proceedings.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   During the screening, a full medical history was recorded for each participant, and blood was drawn to test for: HIV, HCV, hepatitis B, VDRL, full blood count, kidney and liver function, pregnancy (through rapid test in women of childbearing age); to measure the background of IgG anti-RBD, blocking antibodies of ACE2-RBD interaction, viral neutralization test and to explore …

   SciScore for 10.1101/2021.02.22.21252091: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The Independent Data Monitoring Committee and Independent Ethics Committee checked recruitment and vaccination proceedings.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   During the screening, a full medical history was recorded for each participant, and blood was drawn to test for: HIV, HCV, hepatitis B, VDRL, full blood count, kidney and liver function, pregnancy (through rapid test in women of childbearing age); to measure the background of IgG anti-RBD, blocking antibodies of ACE2-RBD interaction, viral neutralization test and to explore cellular immunity.	anti-RBD suggested: None
   Seroconversion rates for IgG antibodies anti-RBD (≥4-fold increase in antibody concentration over pre-immunization levels) were calculated, as well as frequency of participants with in vitro inhibitory antibody titers >70%.	IgG suggested: None
   Software and Algorithms
   Sentences	Resources
   Statistical analyses were done using SPSS version 25.0; EPIDAT version 4.1 and Prism GraphPad version 6.0.	SPSS suggested: (SPSS, RRID:SCR_002865) Prism suggested: (PRISM, RRID:SCR_005375) GraphPad suggested: (GraphPad Prism, RRID:SCR_002798)

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   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).

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   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.

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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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3. 

   Version published to 10.1101/2021.02.22.21252091v1 on medRxiv

   Mar 3, 2021