Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152

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1. 

   ScreenIT

   Sep 16, 2020

   SciScore for 10.1101/2020.09.09.285445: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IACUC: Animal husbandry practices: All animal experiments were performed after obtaining necessary approvals from the Institutional Animal Ethics Committee (IAEC).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The primary antibodies used were anti-N protein rabbit monoclonal Ab (1:1000 dilution) and anti-S1 or S2 or RBD protein rabbit polyclonal Ab (1:1000 dilution), either sourced from commercial or in-house and human convalescent sera from patients (1:500 dilution) at 4°C.	anti-N protein suggested: None anti-S1 sugge…

   SciScore for 10.1101/2020.09.09.285445: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IACUC: Animal husbandry practices: All animal experiments were performed after obtaining necessary approvals from the Institutional Animal Ethics Committee (IAEC).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The primary antibodies used were anti-N protein rabbit monoclonal Ab (1:1000 dilution) and anti-S1 or S2 or RBD protein rabbit polyclonal Ab (1:1000 dilution), either sourced from commercial or in-house and human convalescent sera from patients (1:500 dilution) at 4°C.	anti-N protein suggested: None anti-S1 suggested: None
   The secondary antibodies goat anti-rabbit IgG H&L (HRP) (GE NA934,1:4000) and HRP-labeled goat anti-human IgG (gamma chain) cross-adsorbed secondary antibody (Invitrogen, 62-8420) (1:1000)	anti-human IgG suggested: (Innovative Research Cat# 62-8420, RRID:AB_88136)
   ) conjugated antibody for mouse sera samples, and Goat anti-rabbit IgG HRP conjugate antibody(Santa Cruz Biotechnology, USA) (	anti-rabbit IgG suggested: None antibody(Santa suggested: None
   The antibody dilution, at which absorbance is above the threshold, was taken as antigen-specific antibody endpoint titers. 10. Immunoglobulin (IgG) Subclass: Th1-dependent IgG2a vs.	Immunoglobulin ( IgG suggested: None
   Th2 -dependent IgG1 antibody subclasses were determined from mice vaccinated sera as previously described 37.	IgG1 suggested: None
   After incubation, wells were washed and added with anti-mouse IgG1 or IgG2a HRP conjugate antibodies at a dilution 1:2500.	anti-mouse IgG1 suggested: None
   The antibody dilution, at which absorbance is above the threshold, was taken as antigen-specific antibody endpoint titers. 11. Cytokine (IFNγ & IFNα) Estimation by ELISA: To determine IFNγ, Enzyme-Linked Immunosorbent Assay (ELISA) was performed according to the instruction manual.	antigen-specific suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Vero cells were revived from GMP master cell bank, which was extensively characterized at BioReliance, USA. SARS-CoV-2	Vero suggested: CLS Cat# 605372/p622_VERO, RRID:CVCL_0059)
   To perform PRNT90, Vero CCL-81 cell suspension (1.0 × 105 /mL/well) was added in duplicates in 24-well tissue culture plates and cultured in a CO2 incubator at 37°C for 16-24 hrs.	Vero CCL-81 suggested: None
   Experimental Models: Organisms/Strains
   Sentences	Resources
   Maximum Tolerated Dose Test or Single Dose Toxicity Study: Two animals (Swiss Albino mice and Wistar Rats) species were tested with Algel-IMDG with a single maximum dose (containing 200μg Algel and 20μg TLR7/8 agonist molecule).	Wistar suggested: None
   Animals (Swiss Albino mice and Wistar Rats) were administered via an intramuscular route with Algel-IMDG on day 0 and observed for clinical signs, mortality, and changes in body weight if any up to 14 days.	Swiss Albino suggested: None
   Software and Algorithms
   Sentences	Resources
   Vero cells were revived from GMP master cell bank, which was extensively characterized at BioReliance, USA. SARS-CoV-2	BioReliance suggested: (BioReliance, RRID:SCR_003791)

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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 major limitation of this paper is the lack of protective efficacy results conferred from BBV 152. Additional live challenge studies in hamsters and non-human primates are completed at NIV, India, and results will be published shortly. With no established correlate of protection, we also evaluated human convalescent sera from recovered symptomatic SARS-CoV-2 patients. Samples were collected 21 days after virological confirmation (Figure3C). Furthermore, two other SARS-CoV-2 inactivated vaccines (BBIBP-CorV and PiCoVacc) from China have entered late-stage human clinical trials with published data on the preclinical immune response. Results from these candidates have reported comparable findings, albeit PRNT5033, 34. Bharat Biotech has developed a promising inactivated whole virion vaccine candidate which has now entered phase 1/2 clinical development (NCT04471519). The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of two intramuscular doses of BBV152 in healthy volunteers.

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

   Identifier	Status	Title
   NCT04471519	Active, not recruiting	Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COV…

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   Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

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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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   Read the original source
2. 

   Version published to 10.1101/2020.09.09.285445 on bioRxiv

   Sep 9, 2020