Effect of the third dose of BNT162b2 vaccine on quantitative SARS-CoV-2 spike 1–2 IgG antibody titers in healthcare personnel

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1. Version published to 10.1371/journal.pone.0263942

   Mar 2, 2022
2. 

   ScreenIT

   Oct 23, 2021

   SciScore for 10.1101/2021.10.20.21265269: (What is this?)

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

   Table 1: Rigor

   Ethics

   IRB: The study was approved by the local Institutional Review Board (Ref.:26022021-CN-1e-CI) and conducted per the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments that involve humans. Consent: The inclusion criteria for the patients’ recruitment were individuals of both genders between the age of 18 and 100 years old, who had accepted and signed an informed consent form and pretended to complete the BNT126b2 regimen.

   Sex as a biological variable

   The inclusion criteria for the patients’ recruitment were individuals of both genders between the age of 18 and 100 years old, who had accepted and signed an informed consent form and pretended to complete the …

   SciScore for 10.1101/2021.10.20.21265269: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: The study was approved by the local Institutional Review Board (Ref.:26022021-CN-1e-CI) and conducted per the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments that involve humans. Consent: The inclusion criteria for the patients’ recruitment were individuals of both genders between the age of 18 and 100 years old, who had accepted and signed an informed consent form and pretended to complete the BNT126b2 regimen.
   Sex as a biological variable	The inclusion criteria for the patients’ recruitment were individuals of both genders between the age of 18 and 100 years old, who had accepted and signed an informed consent form and pretended to complete the BNT126b2 regimen.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The individuals were introduced to the research process, which consisted of a follow-up during an entire year through SARS-CoV-2 specific IgG antibodies measurement samples followed by questionnaires.	SARS-CoV-2 specific IgG suggested: None
   Since this protocol was approved after the application of the first BNT, twenty-one days after receiving the first dose, the research team reached every participant to take a plasma sample for the IgG antibodies measurement and apply the first questionnaire.	IgG suggested: None
   The third, fourth, and fifth IgG antibodies samples were planned to be taken three, six, and twelve months after completing the two-dose regimen of BNT126b2, respectively.	fifth IgG suggested: None
   The equipment used by the laboratory personnel to analyze the samples was the LIAISON SARS-CoV-2 S1 / S2 IgG antibody detection kit (Italy).	S2 IgG suggested: None
   To determine the amount of specific anti-S1 and anti-S2 IgG antibodies against SARS-CoV-2 in plasma samples, the laboratory personnel used the chemiluminescence immunoassay (CLIA); which had a sensitivity of 97.4% (95% CI, 86.8-99.5) and a specificity of 98.5% (95% CI, 97.5-99.2).	anti-S1 suggested: None 86.8-99.5 suggested: (GenWay Biotech Inc. Cat# GWB-868995, RRID:AB_10516413)
   In the three-month follow-up, there was a decrease in the amount of specific anti-S1 and anti-S2 IgG antibodies against SARS-CoV-2.	SARS-CoV-2 suggested: None
   The analyzed biochemical variables were: SARS-CoV-2 quantitative antibodies from 21-28 days post-BNT126b2 first dose (S1), 21-28 days post-BNT126b2 second dose (S2), three-month follow-up after completing the two-dose BNT126b2 regimen (S3), and 1-7 days (S4) and 21-28 days post-BNT-boost (S5).	S3 suggested: None S5 suggested: None
   Software and Algorithms
   Sentences	Resources
   The statistical program used was SPSS, version 2.	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:

   A limitation to our study was that the recruited group did not have a baseline sample taken before the first BNT162b2 dose because our protocol was approved after the health workers had received the first dose. However, we believe that this study is significant because of the non-immunocompromised population that we used. Another limitation was the analysis of the third dose’s side effects only in the short-term (21-28 days after the booster dose). We will continue following this cohort group to see any long-term side effects related to the vaccine, but we just reported the short-term side effects for this study.

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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 10.1101/2021.10.20.21265269 on medRxiv

   Oct 21, 2021