Immunogenicity and reactogenicity against the SARS-CoV-2 variants following heterologous primary series involving CoronaVac, ChAdox1 nCov-19 and BNT162b2 plus BNT162b2 booster vaccination: An open-label randomized study in healthy Thai adults

Version published to 10.1080/21645515.2022.2091865

Jul 11, 2022

SciScore for 10.1101/2022.03.03.22271601: (What is this?)

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

Table 1: Rigor

Ethics	IRB: The clinical study was approved by the Siriraj Institutional Ethics Review Board (approval no.Si537/2021). Consent: Procedures: Participants were recruited into the study following informed consent and were randomised to one of seven prime-boost groups: CoronaVac-ChAdOx1, CoronaVac-BNT162b2, ChAdOx1-CoronaVac, ChAdOx1-BNT162b2, BNT162b2-CoronaVac, BNT162b2-ChAdOx1 or homologous BNT162b2.
Sex as a biological variable	The exclusion criteria were unstable underlying disease, having acute illness, had a history of anaphylaxis; were pregnant females, were immunocompromised or receiving immunosuppressants at screening.
Randomization	Procedures: Participants were recruited into the study following informed consent and were randomised to one of seven prime-boost groups: CoronaVac-ChAdOx1, CoronaVac-BNT162b2, ChAdOx1-CoronaVac, ChAdOx1-BNT162b2, BNT162b2-CoronaVac, BNT162b2-ChAdOx1 or homologous BNT162b2.
Blinding	not detected.
Power Analysis	not detected.
Cell Line Authentication	not detected.

Table 2: Resources

Antibodies
Sentences	Resources
Participants who had a positive anti-nucleoprotein (anti-NP) or anti-RBD IgG antibody at baseline were excluded.	anti-nucleoprotein suggested: None anti-NP suggested: None
The anti-RBD IgG antibody responses were presented as geometric mean concentrations (GMC) with 95% confidence intervals (CI).	anti-RBD IgG suggested: None
Experimental Models: Cell Lines
Sentences	Resources
After removing the culture medium from Vero cell culture plates, 200 ul of the virus-serum antibody mixture were inoculated into monolayer Vero cells.	Vero suggested: CLS Cat# 605372/p622_VERO, RRID:CVCL_0059)
Briefly, Human embryonic kidney (HEK) 293T/17 cells were transfected with the pCAGGS-S expression vector (Delta or Omicron) in conjunction with p8.9171 and pCSFLW72 using polyethylenimine (PEI, Polysciences, Warrington, USA).	HEK suggested: None 293T/17 suggested: ATCC Cat# CRL-11268, RRID:CVCL_1926)
Briefly, HEK293T cells overexpressing human ACE2 were maintained in Dulbecco’s modified Eagle’s medium (DMEM) supplemented with 10% FBS, 200mM L-glutamine, 100μg/ml streptomycin and 100 IU/ml penicillin.	HEK293T suggested: None
Recombinant DNA
Sentences	Resources
Briefly, Human embryonic kidney (HEK) 293T/17 cells were transfected with the pCAGGS-S expression vector (Delta or Omicron) in conjunction with p8.9171 and pCSFLW72 using polyethylenimine (PEI, Polysciences, Warrington, USA).	pCAGGS-S suggested: None pCSFLW72 suggested: None
At 24 hours before the assay, cells (5×105 cells/ml cells in 10 mm dish) were transfected with pCAGGS expressing codon-optimized human TMPRSS2 using Fugene HD transfection reagent (Promega)	pCAGGS suggested: RRID:Addgene_127347)
Software and Algorithms
Sentences	Resources
The qualitative anti-NP IgG was also measured by CMIA using the SARS-CoV-2 IgG (Abbott, List No. 06R86) on the ARCHITECT i System.	Abbott suggested: (Abbott, RRID:SCR_010477)
Antibody titer was then calculated by interpolating the point at which infectivity had been reduced to 50% of the value for the no serum control samples using GraphPad Prism 9.0 software.	GraphPad Prism suggested: (GraphPad Prism, RRID:SCR_002798)
All statistical analyses were conducted using STATA version 17 (StataCorp, LP, College Station, TX, USA).	STATA suggested: (Stata, RRID:SCR_012763) StataCorp suggested: (Stata, RRID:SCR_012763)

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:

Limitations of this study were that the participants were not blinded for the study vaccine, which may have influenced the reporting of adverse reactions. Secondly, the small sample size in each group did not allow us to identify any potential rare AEs. However, findings from this study have been used to inform the Thailand National COVID-19 vaccination program recommendation by including the CoronaVac-ChAdOx1 regimen during the time when mRNA vaccines were not available. Ongoing surveillance of any rare AEs and the clinical effectiveness of this heterologous schedule will inform the feasibility of such schedule against the SARS-CoV-2 variants. Lastly, the BNT162b2 booster in this study was only given to two groups who received CoronaVac and ChAdOx1, and there was no homologous three-dose BNT162b2 group for comparison of their immunogenicity. Despite this, it was clear that BNT162b2 as the third booster vaccination provided high neutralizing activity against Delta and Omicron, which is likely to provide protection against these two predominant variants. Future studies incorporating mRNA booster to other heterologous primary schedules will be of interest, particularly with other COVID-19 vaccines that have recently received WHO EUL. In conclusion, we found that heterologous COVID-19 primary series using either ChAdOx1 or BNT162b2 as second dose were highly immunogenic against SARS-CoV-2 ancestral strain, Beta and Delta variants, but low neutralizing antibody against Omicron. A...

Results from TrialIdentifier: No clinical trial numbers were referenced.

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.
No protocol registration statement was detected.

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

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Immunogenicity and reactogenicity against the SARS-CoV-2 variants following heterologous primary series involving CoronaVac, ChAdox1 nCov-19 and BNT162b2 plus BNT162b2 booster vaccination: An open-label randomized study in healthy Thai adults

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