Safety and superior immunogenicity of heterologous boosting with an RBD-based SARS-CoV-2 mRNA vaccine in Chinese adults
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SciScore for 10.1101/2022.05.30.22275753: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethics statement: The trial was reviewed and approved by the Research Ethics Committee of the Center for Disease Control and Prevention of Yunnan province.
Consent: Written informed consents were obtained from each participant before the screening.Sex as a biological variable Participants with a previous clinical or virologic COVID-19 diagnosis or SARS-CoV-2 infection or women with positive urine pregnancy test results were excluded from this study. Randomization Study design: We conducted a randomized clinical trial involving 300 adults (≥18 years of age) who were tested negative by RT-PCR screening for COVID-19 at the time of participation to elucidate the immunogenicity and safety of … SciScore for 10.1101/2022.05.30.22275753: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethics statement: The trial was reviewed and approved by the Research Ethics Committee of the Center for Disease Control and Prevention of Yunnan province.
Consent: Written informed consents were obtained from each participant before the screening.Sex as a biological variable Participants with a previous clinical or virologic COVID-19 diagnosis or SARS-CoV-2 infection or women with positive urine pregnancy test results were excluded from this study. Randomization Study design: We conducted a randomized clinical trial involving 300 adults (≥18 years of age) who were tested negative by RT-PCR screening for COVID-19 at the time of participation to elucidate the immunogenicity and safety of an mRNA-based vaccine (AWcorna) as a booster compared to that of homologous booster using an inactivated viral vaccine (CoronaVac). Blinding Since the different appearances of the two kinds of vaccines, inoculators could not keep in blind when vaccines had been used. Power Analysis Sample size: The sample size was determined based on the hypothesis that the booster vaccination of mRNA vaccine following the two-dose inactivated vaccine regimen be non-inferior to that of the booster of inactivated vaccine in neutralizing antibody. Cell Line Authentication Authentication: Randomization: Each participant was assigned a unique subject ID by authorized assigners successively according to a Prespecified allocation kit, which was generated by an independent randomization statistician from Beijing Key Tech Statistical Consulting Co., Ltd. via SAS software (SAS® Institute, Cary, North Carolina, USA) with the ratio of 2:1 to the AWcorna and CoronaVac groups. Table 2: Resources
Antibodies Sentences Resources Laboratory assays: The neutralizing antibodies in sera against the wild-type strain (GenBank: MT123291), Delta variant (IQTC-IM2175251), and Omicron variant (IQTC-Y216017) (Guangzhou Customs Technology Center, Guangzhou, China) were determined by using a cytopathic effect (CPE)-based microneutralization assay. IQTC-Y216017) (Guangzhou Customs Technology Center, Guangzhou, China)suggested: NoneThe WHO reference (NIBSC code: 20/136) is equivalent to a live viral neutralizing antibody titer of 1:139 against wild-type SARS-CoV-2 and a titer of 1:213 against the Delta variant B.1.617.2, while the WHO reference (1,000 BAU/ml in serum) is equivalent to an RBD-specific IgG ELISA antibody titer of 1:5,490. RBD-specific IgGsuggested: NoneExperimental Models: Cell Lines Sentences Resources Vero E6 cells were trypsinized and resuspended in Dulbecco’s Modified Eagle Medium (DMEM) containing 4% of fetal bovine serum and 1% of pen/strep at a concentration of 1.2×105 cells/ml and 100 μl of cells suspension were then added into the 96-well plates, followed by incubation at 37 °C, 5% CO2 for 4 days. Vero E6suggested: RRID:CVCL_XD71)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04847102 Recruiting A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonuc… 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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