Neutralizing antibodies against SARS-CoV-2 variants of concern elicited by the comirnaty COVID-19 vaccine in nursing home residents

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1. Version published to 10.1038/s41598-022-07849-2

   Mar 8, 2022
2. 

   ScreenIT

   Oct 10, 2021

   SciScore for 10.1101/2021.10.06.21264607: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: The study was approved by INCLIVA Research Ethics Committee. Consent: Informed consent was obtained from all participants.
   Sex as a biological variable	Group 2 comprised 18 healthy individuals (14 females) aged a median of 47.5 years (range, 26-62).
   Randomization	Group 1 included 30 nursing home (NH) residents with frailty and one or more co-morbidities (23 females), randomly selected from one NH affiliated to the Clínico-Malvarrosa Health Department, Valencia (Spain), aged a median of 90 years (range 64-100).
   Blinding	not detected.
   Power Analysis	not detected.
   Cell Line Authentication	Authentication: In all cases, the variant Wuhan/D614G was involved, as determined by whole-genome sequencing …

   SciScore for 10.1101/2021.10.06.21264607: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: The study was approved by INCLIVA Research Ethics Committee. Consent: Informed consent was obtained from all participants.
   Sex as a biological variable	Group 2 comprised 18 healthy individuals (14 females) aged a median of 47.5 years (range, 26-62).
   Randomization	Group 1 included 30 nursing home (NH) residents with frailty and one or more co-morbidities (23 females), randomly selected from one NH affiliated to the Clínico-Malvarrosa Health Department, Valencia (Spain), aged a median of 90 years (range 64-100).
   Blinding	not detected.
   Power Analysis	not detected.
   Cell Line Authentication	Authentication: In all cases, the variant Wuhan/D614G was involved, as determined by whole-genome sequencing (not shown).

   Table 2: Resources

   Antibodies
   Sentences	Resources
   Twenty-two were SARS-CoV-2 naïve, as judged by a lack of antibodies targeting the SARS-CoV-2 nucleoprotein (N), and 8 had contracted COVID-19 requiring hospitalization prior to receiving the first dose of the Comirnaty® COVID-19 vaccine, as determined by positive RT-PCR results in nasopharyngeal specimens and the detection of SARS-CoV-2 N antibodies.	SARS-CoV-2 nucleoprotein (N), suggested: None
   Sera testing negative (undetectable) were arbitrarily ascribed a titer of 1/20. Quantitation of SARS-CoV-2 receptor binding domain-reactive antibodies: Total antibodies (IgG and IgM) against the SARS-CoV-2 S protein receptor-binding domain (RBD) were measured by Roche Elecsys® electrochemiluminescence sandwich immunoassays (Roche Diagnostics, Pleasanton, CA, USA).	antibodies: Total antibodies (IgG suggested: None SARS-CoV-2 S protein receptor-binding domain (RBD suggested: None
   The assay is calibrated with the first WHO International Standard and Reference Panel for anti-SARS-CoV-2 antibody [16].	anti-SARS-CoV-2 suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Virus neutralization assay: The neutralization capacity of circulating antibodies (NtAb) against the SARS-CoV-2 S protein was assessed using a GFP-expressing vesicular stomatitis virus pseudotyped with different Spike variants as previously described [15], but using A549-ACE2-TMPRSS2 cells (InvivoGen catalog code a549-hace2tps).	A549-ACE2-TMPRSS2 suggested: None
   Software and Algorithms
   Sentences	Resources
   The analyses were performed using SPSS version 20.0 (SPSS, Chicago, IL, USA).	SPSS suggested: (SPSS, RRID:SCR_002865)

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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:

   The relatively small sample size could be considered a limitation of the current study. Also, a limitation inherent to the use of S-pseudotyped viruses is the inability to assess the impact of variations in other viral genes outside of the S protein that could affect sera neutralization. In summary, herein we show that neutralizing activity of sera against SARS-CoV-2 variants carrying critical escape mutations in the S gene is decreased relative to the ancestral strain in both qualitative and quantitative terms in nursing home residents recently vaccinated with the Comirnaty® COVID-19 vaccine. Nevertheless, the fold reduction in NtAb activity in this population group was not different from that seen in vaccinated controls and recovered COVID-19 individuals who had not been vaccinated. Importantly, among VOCs, the Delta variant that is currently predominant worldwide was best neutralized by sera from participants in all study groups. Nevertheless, the degree to which reduced neutralization activity of the different VOCs, and especially the Delta variant, impact infection and/or disease in vaccinated nursing home residents translate into diminished effective protection is currently under investigation.

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

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3. 

   Version published to 10.1101/2021.10.06.21264607v1 on medRxiv

   Oct 7, 2021