Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving monoclonal antibodies

Version published to 10.1038/s41591-022-01792-5

Mar 23, 2022

SciScore for 10.1101/2022.03.09.22272066: (What is this?)

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

Table 1: Rigor

Ethics	IACUC: This study was approved by the Est II (Besançon) ethical committee. Consent: At enrolment, written informed consent was collected and participants completed a questionnaire which covered sociodemographic characteristics, clinical information, and data related to anti-SARS-CoV-2 vaccination.
Sex as a biological variable	not detected.
Randomization	The experiments were not randomized and the investigators were not blinded to allocation during experiments and outcome assessment.
Blinding	The experiments were not randomized and the investigators were not blinded to allocation during experiments and outcome assessment.
Power Analysis	Design: No statistical methods were used to predetermine sample size.
Cell Line Authentication	Contamination: Cells tested negative for mycoplasma.

Table 2: Resources

Antibodies
Sentences	Resources
Anti-spike serology: The S-Flow assay uses 293T cells stably expressing the spike protein (293T Spike cells) and 293T control cells as control to detect anti-S antibodies by flow cytometry (Grzelak et al., 2021)..	anti-S suggested: None
Cells were then washed with PBS and stained with an anti-human IgG Fc Alexafluor 647 antibody (109-605-170, Jackson ImmunoResearch).	anti-human IgG suggested: (Jackson ImmunoResearch Labs Cat# 109-605-170, RRID:AB_2810901)
A standard curve with serial dilutions of a human anti-spike monoclonal antibody (mAb48) was acquired in each assay to standardize the results.	anti-spike suggested: None
Experimental Models: Cell Lines
Sentences	Resources
Titration of viral stocks was performed on Vero E6, with a limiting dilution technique allowing a calculation of TCID50, or on S-Fuse cells.	Vero E6 suggested: None
Anti-spike serology: The S-Flow assay uses 293T cells stably expressing the spike protein (293T Spike cells) and 293T control cells as control to detect anti-S antibodies by flow cytometry (Grzelak et al., 2021)..	293T suggested: None
Software and Algorithms
Sentences	Resources
To determine BAU/mL, we analyzed a series of vaccinated (n=144), convalescent (n=59) samples and WHO international reference sera (20/136 and 20/130) on S-Flow and on two commercially available ELISA (Abbott 147 and Beckmann 56).	Abbott suggested: (Abbott, RRID:SCR_010477)
Statistical analysis: Flow cytometry data were analyzed with FlowJo v10 software (TriStar).	FlowJo suggested: (FlowJo, RRID:SCR_008520)
Figures were drawn on Prism 9 (GraphPad Software).	GraphPad suggested: (GraphPad Prism, RRID:SCR_002798)
Statistical analysis was conducted using GraphPad Prism 9.	GraphPad Prism suggested: (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: We detected the following sentences addressing limitations in the study:

Our study has limitations. The relatively low number of individuals analyzed did not allow evaluating the clinical efficacy of Evusheld against BA.2. We did not have access to nasopharyngeal samples of the patients. Measuring antibody levels and neutralization in these swabs will help providing insights into the capacity of mAbs to neutralize Omicron sub-lineages at the infection site. We did not test BA.1.1 and BA.3 sub-lineages of Omicron. Future experiments with these viruses are needed to determine the antiviral activity of mAbs against the full landscape of the Omicron clade, which we recently proposed to be considered as a distinct SARS-CoV-2 serotype from ancestral strains and previous variants (Simon-Loriere and Schwartz, 2022). Based on our observation of breakthrough infections and awaiting clinical trials which will provide a complete evaluation of the impact of BA.2 on the treatment efficacy of mAbs, we expect more frequent treatment failures. It is also possible that the progressive accumulation of further mutations will increase the level of resistance of BA.1 or BA.2 to mAbs during prolonged infection. The low or intermediate sensitivity to Ronapreve and Evusheld, when used as a pre-exposure prophylaxis in immunocompromised persons at risk for severe disease is of potential concern. The risk that further escape mutations will arise in these patients is higher compared to Delta. We therefore recommend a close follow-up of these patients, particularly in case of ...

Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

Identifier	Status	Title
NCT04750720	Recruiting	Study of the Kinetics of COVID-19 Antibodies for 24 Months i…
NCT04870411	Recruiting	Immunological Response to COVID-19 Vaccine in Patients With …

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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Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving monoclonal antibodies

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