Analysis of immunization time, amplitude, and adverse events of seven different vaccines against SARS-CoV-2 across four different countries

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1. Version published to 10.3389/fimmu.2022.894277

   Jul 28, 2022
2. 

   ScreenIT

   Mar 16, 2022

   SciScore for 10.1101/2022.03.11.22272153: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: The study was approved by each local Institutional Review Board and conducted per the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments that involve humans. Consent: On the vaccination day, the research team invited any subject who planned to receive any vaccine scheme, explained the project and asked to sign the informed consent.
   Sex as a biological variable	The inclusion criteria were volunteers of both genders, any age, who consented to participate, planned to conclude the immunization regimen of any vaccine, and agreed to be followed up for the duration of the study.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	A sample size of …

   SciScore for 10.1101/2022.03.11.22272153: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: The study was approved by each local Institutional Review Board and conducted per the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments that involve humans. Consent: On the vaccination day, the research team invited any subject who planned to receive any vaccine scheme, explained the project and asked to sign the informed consent.
   Sex as a biological variable	The inclusion criteria were volunteers of both genders, any age, who consented to participate, planned to conclude the immunization regimen of any vaccine, and agreed to be followed up for the duration of the study.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	A sample size of 1870 patients was calculated, according to the primary aim, by using a mixed model formula with an alpha of 0.05, power of 90%, the effect size of 0.15, and k=7.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   To determine the amount of specific anti-S1 and anti-S2 IgG antibodies against SARS-CoV-2 in plasma samples, the laboratory personnel used a chemiluminescence immunoassay (CLIA) developed by DiaSorin, 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).	86.8-99.5 suggested: (GenWay Biotech Inc. Cat# GWB-868995, RRID:AB_10516413)
   Anti-S1 and anti-S2 IgG antibodies against SARS-CoV-2 were measured at baseline, 21-28 days post-first dose (S1), and 21-28 days post-second dose if applicable.	Anti-S1 suggested: None anti-S2 IgG suggested: None SARS-CoV-2 suggested: None
   Software and Algorithms
   Sentences	Resources
   4.0.3 and Python v. 3.8.3.	Python suggested: (IPython, RRID:SCR_001658)

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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:

   As a limitation of our study, we recognize that we had a small sample size in some vaccine groups such as Ad5-nCoV; however, to the best of our knowledge, there is no other study where this type of vaccine has been compared to other types of vaccines in a real-world setting. It will be of interest to follow the IgG titers for a longer period and to evaluate the effect of heterologous combinations of these vaccines. This comparative study of vaccine types shows positive immunogenicity and seroconversion of BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV, and Ad26.COV2. The highest IgG response was for the mRNA vector vaccines and the lower for the inactivated vaccine. Women and young individuals developed more AEs. In the naïve SARS-CoV-2 cohort, the vaccines Gam-COVID-Vac, Coronavac, and ChAdOx1-S were related to fewer AEs after the second dose of BNT162b mRNA. For patients who received Gam-COVID-Vac, higher antibody levels after the second dose were related to a greater number of AEs. In people previously exposed to SARS-CoV-2, those receiving Gam-COVID-Vac showed a greater number of AEs than BNT162b mRNA, while subjects receiving Coronavac showed significantly fewer events when compared to BNT162b mRNA. In general, an increase in antibody levels was related to AEs.

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

   Identifier	Status	Title
   NCT05228912	Recruiting	Immunization of 7 Different Vaccines Against SARS-COV-2 Acro…

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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.
   • Thank you for including a protocol registration statement.

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

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3. 

   Version published to 10.1101/2022.03.11.22272153 on medRxiv

   Mar 13, 2022