The anti–SARS-CoV-2 monoclonal antibody bamlanivimab minimally affects the endogenous immune response to COVID-19 vaccination

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1. Version published to 10.1126/scitranslmed.abn3041

   Jul 27, 2022
2. 

   ScreenIT

   Dec 19, 2021

   SciScore for 10.1101/2021.12.15.21267605: (What is this?)

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

   Table 1: Rigor

   NIH rigor criteria are not applicable to paper type.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The transferred solution was combined with ACE2 coated beads and incubated for 60 minutes, while the remaining beads were washed and incubated for 60 minutes with anti-IgG-PE beads to detect bound antibodies.	anti-IgG-PE suggested: None
   Figure S1: Antibody titers against SARS-CoV-2 beta variant (B.1.351) for fully vaccinated participants who (a) previously received either bamlanivimab or placebo infusion (b) who were resident of staff and were subsequently fully vaccinated (SpikeVax or Comirnaty) against COVID-19.	COVID-19 suggested: None
   (b) Correlation plot of neutralization potency against beta variant …

   SciScore for 10.1101/2021.12.15.21267605: (What is this?)

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

   Table 1: Rigor

   NIH rigor criteria are not applicable to paper type.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The transferred solution was combined with ACE2 coated beads and incubated for 60 minutes, while the remaining beads were washed and incubated for 60 minutes with anti-IgG-PE beads to detect bound antibodies.	anti-IgG-PE suggested: None
   Figure S1: Antibody titers against SARS-CoV-2 beta variant (B.1.351) for fully vaccinated participants who (a) previously received either bamlanivimab or placebo infusion (b) who were resident of staff and were subsequently fully vaccinated (SpikeVax or Comirnaty) against COVID-19.	COVID-19 suggested: None
   (b) Correlation plot of neutralization potency against beta variant and against E484Q Figure S5: Longitudinal antibody responses against spike-NTD arranged into three groups based on the interval (days) between bamlanivimab or placebo infusion and first vaccine dose, T1.	T1 suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Briefly, 293T cells were transfected with individual mutant spike expression plasmids, and 16-20 hours later, transfected cells were infected with VSV-G-pseudotyped delta-G luciferase rVSV, and 16-20 hours thereafter conditioned culture medium was harvested, clarified by centrifugation at 1320 g for 10 minutes at 4°C, aliquoted and stored frozen at - 80°C.	293T suggested: RRID:CVCL_H376)
   Relative luciferase reporter signal read-out was determined by luciferase assay (Promega E2650) of extracts from VeroE6 cells infected with serially-diluted virus.	VeroE6 suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)

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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: We detected the following sentences addressing limitations in the study:

   This study has several limitations; First, this analysis was not a pre-planned component of the BLAZE-2 trial and therefore vaccine type and timing were determined by circumstance. Consequently, the post-hoc analysis population was determined as described in the Materials and Methods and therefore the data presented are limited by the sample size and demographics. A total of 499 samples from fully vaccinated participants who met the inclusion criteria were assessed for antibody titer and ACE2 binding inhibition potency using a custom Luminex-based assay. Owing to the custom nature of this assay, it was decided to perform a standard pseudovirus neutralization assay to complement and corroborate these data. Due to logistical limitations, purposive sampling was used to select samples for the pseudovirus assay from a subset of participants (N=49) who received their first vaccine within 64 days of either bamlanivimab or placebo. This group of participants were selected as they represented those most likely to exhibit an effect of bamlanivimab on pseudovirus neutralization potency. Despite the smaller sample, the neutralization potency against Spike-RBD-E484Q and the beta variant pseudoviruses were strongly correlated, further supporting our interpretation of minimal impact. This analysis only assessed the impact of a single mAb on the endogenous immune response to a COVID-19 vaccine, however, we hypothesize similar results for other mAbs that reduce viral load upon administration ...

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

   Identifier	Status	Title
   NCT04497987	Completed	A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) i…

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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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   Results from scite Reference Check: We found no unreliable references.

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3. 

   Version published to 10.1101/2021.12.15.21267605 on medRxiv

   Dec 16, 2021