Collaboration between the Fab and Fc contribute to maximal protection against SARS-CoV-2 in nonhuman primates following NVX-CoV2373 subunit vaccine with Matrix-M™ vaccination

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   ScreenIT

   Mar 1, 2021

   SciScore for 10.1101/2021.02.05.429759: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IACUC: Animal ethics statement: The immunization and challenge phases of the study complied with all applicable sections of the Final Rules of the Animal Welfare Act regulations (9 CFR Parts 1, 2, and 3) and Guide for the Care and Use of Laboratory Animals - National Academy Press, Washington D. C. 8th Edition, 2011 (The Guide). Consent: All subjects signed informed consent and safety oversight was monitored by a data monitoring board.
   Randomization	With the exception of 6 sentinel participants vaccinated in an open-label manner, the remaining 125 participants were randomly assigned to vaccine and placebo groups in a blinded fashion.
   Blinding	With the exception of 6 …

   SciScore for 10.1101/2021.02.05.429759: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IACUC: Animal ethics statement: The immunization and challenge phases of the study complied with all applicable sections of the Final Rules of the Animal Welfare Act regulations (9 CFR Parts 1, 2, and 3) and Guide for the Care and Use of Laboratory Animals - National Academy Press, Washington D. C. 8th Edition, 2011 (The Guide). Consent: All subjects signed informed consent and safety oversight was monitored by a data monitoring board.
   Randomization	With the exception of 6 sentinel participants vaccinated in an open-label manner, the remaining 125 participants were randomly assigned to vaccine and placebo groups in a blinded fashion.
   Blinding	With the exception of 6 sentinel participants vaccinated in an open-label manner, the remaining 125 participants were randomly assigned to vaccine and placebo groups in a blinded fashion.
   Power Analysis	not detected.
   Sex as a biological variable	Healthy 18-59-year-old men and non-pregnant women were included in the study.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   Brefeldin A (Sigma), and anti-human CD107a antibody (BD Bioscience).	anti-human CD107a suggested: None
   Isotyping was performed by incubating the immune complexes with secondary mouse-anti-rhesus antibody detectors for each isotype (IgG1, IgG2, IgG3, IgG4, IgA), then detected with tertiary anti-mouse-IgG antibodies conjugated to PE.	anti-mouse-IgG suggested: (Proteintech Cat# 10283-1-AP, RRID:AB_2877728)
   Experimental Models: Cell Lines
   Sentences	Resources
   Cell line, viruses, and receptor: Vero E6 cells were obtained from ATCC, CRL-1586 and maintained in Minimal Eagles Medium (MEM) supplemented with 10% fetal bovine serum (FBS), 1% glutamine, and 1% penicillin and streptomycin (P/S).	Vero E6 suggested: None
   HEK 293T/ACE2 cells were obtained from Drs.	HEK 293T/ACE2 suggested: None
   Pseudovirions were produced in HEK 293T/17 cells (ATCC cat. no. CRL-11268, Manassas, VA, USA) by transfection using Fugene 6 (catalog number E2692, Promega, Madison, WI, USA) and a combination of spike plasmid, lentiviral backbone plasmid (pCMV ΔR8.2) and firefly Luc reporter gene plasmid (pHR’ CMV Luc) in a 1:17:17 ratio55.	HEK 293T/17 suggested: ATCC Cat# CRL-11268, RRID:CVCL_1926)
   THP-1 cells were then washed and fixed in 4% PFA, while the RBC-lyzed whole blood was washed, stained for CD66b+ (Biolegend) to identify neutrophils, and then fixed in 4% PFA.	THP-1 suggested: None
   Experimental Models: Organisms/Strains
   Sentences	Resources
   Matrix-M™ adjuvant was provided by Novavax, AB (lot number M1-111, Uppsala, SWE)52.	AB suggested: None
   Software and Algorithms
   Sentences	Resources
   Individual animal anti-S IgG or IgA titers, and group geometric mean titer (GMT) and 95% confidence interval (95% CI) were plotted using GraphPad Prism 9.0 software.	GraphPad Prism suggested: (GraphPad Prism, RRID:SCR_002798)
   Flow cytometry was performed with an IQue (Intellicyt) or LSRII(BD) and analysis was performed using IntelliCyt ForeCyt (v8.1) or FlowJo V10.7.1.	FlowJo suggested: (FlowJo, RRID:SCR_008520)

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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 found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

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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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   Version published to 10.1101/2021.02.05.429759v1 on bioRxiv

   Feb 5, 2021