GRAd-COV2, a gorilla adenovirus-based candidate vaccine against COVID-19, is safe and immunogenic in younger and older adults

Version published to 10.1126/scitranslmed.abj1996

Jan 12, 2022

SciScore for 10.1101/2021.04.10.21255202: (What is this?)

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

Table 1: Rigor

Institutional Review Board Statement	Consent: Ethical statement: All participants provided written informed consent before enrolment. IRB: The study was conducted according to the Declaration of Helsinki, and approved by the Italian Regulatory Drug Agency (AIFA) and the Italian National Ethical Committee for COVID-19 clinical studies (ClinicalTrials.gov NCT04528641; EudraCT 2020-002835-31). IACUC: Sera from convalescent patients who resolved SARS-CoV-2 infections came from residual specimens used for diagnostic purposes and were utilized according to INMI protocols for observational studies approved form internal ethical committee.
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
S1/S2 IgG test on LIAISON® XL analyzers, a chemiluminescence immunoassays (CLIA) detecting anti-S1/S2 IgG (IgG antibody concentrations expressed as arbitrary units, AU/mL >= 15 are considered positive, DiaSorin, Italy); 2) Abbott SARS-CoV-2 assay on Abbott ARCHITECT® i2000sr, a chemiluminescence microparticle assay (CMIA) detecting anti-N IgG (index value Sample/Cut-off >= 1.4 is considered positive; Abbott Diagnostics, Chicago, IL, USA).	anti-S1/S2 IgG ( IgG suggested: None anti-N IgG suggested: None
Nucleocapsid monoclonal antibody followed by a secondary anti-mouse IgG peroxidase conjugate and TrueBlue substrate, which forms a blue precipitate on positive cells.	anti-mouse IgG suggested: None
Experimental Models: Cell Lines
Sentences	Resources
SARS-CoV-2 Spike and RBD ELISA: SARS-CoV-2 ELISA was developed using as coated antigens either SARS-CoV-2 full length soluble prefusion stabilized Spike protein (expressed in Expi293 cells at ReiThera) or a recombinant RBD (expressed in HEK293 cells, ACROBiosystems).	Expi293 suggested: RRID:CVCL_D615)
Subsequently, 96-well tissue culture plates with sub-confluent Vero E6 cell monolayers were infected with 100 μl/well of virus-serum mixtures and incubated at 37 °C and 5% CO2.	Vero E6 suggested: None
GRAd vector encoding for the reporter gene secreted alkaline phosphatase (SEAP) at a pre-optimized multiplicity of infection (MOI) was preincubated for 1h at 37°C alone or with serial dilutions of control or test serum samples and then added to the 80-90% confluent HEK293 cells.	HEK293 suggested: CLS Cat# 300192/p777_HEK293, RRID:CVCL_0045)
Software and Algorithms
Sentences	Resources
S1/S2 IgG test on LIAISON® XL analyzers, a chemiluminescence immunoassays (CLIA) detecting anti-S1/S2 IgG (IgG antibody concentrations expressed as arbitrary units, AU/mL >= 15 are considered positive, DiaSorin, Italy); 2) Abbott SARS-CoV-2 assay on Abbott ARCHITECT® i2000sr, a chemiluminescence microparticle assay (CMIA) detecting anti-N IgG (index value Sample/Cut-off >= 1.4 is considered positive; Abbott Diagnostics, Chicago, IL, USA).	Abbott suggested: (Abbott, RRID:SCR_010477)

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).

Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

This study has some limitations due to the low number of volunteers per arm (N=15), and to the lack of subject randomization amongst study arms on the basis of GRAd neutralizing titer at baseline. Both these aspects could have had an impact in the poor vaccine dose effect observed. However, the explored dose range (4-fold between low and high dose) was limited, and no major dose effect was expected. Nevertheless, for phase 2/3 single-dose regimen we selected the 2×1011 vp (high) dose, due to higher and more consistent immunogenicity especially in the elderly cohort. As for the two-dose regimen, the intermediate dose of 1×1011 vp was selected which represents the best compromise between tolerability and immunogenicity. Finally, data beyond w4 post vaccination on persistence of humoral and cellular responses will be part of a future report once the study follow up will be completed.

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

Identifier	Status	Title
NCT04791423	Active, not recruiting	Study of GRAd-COV2 for the Prevention of COVID-19 in Adults
NCT04528641	Active, not recruiting	GRAd-COV2 Vaccine Against COVID-19

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

Results from JetFighter: We did not find any issues relating to colormaps.

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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GRAd-COV2, a gorilla adenovirus-based candidate vaccine against COVID-19, is safe and immunogenic in younger and older adults

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