Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2–18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study
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SciScore for 10.1101/2021.12.28.21268468: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The protocol was approved by the Institutional Ethics Committees at each study centre and the study was done in accordance with the revised Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013).
Consent: Eligible participants were healthy children of either gender from 2 to 18 years of age whose parents or legal guardians supplied written informed and audio-video consent; verbal assent was also obtained from children between 7 and 12 years of age, and written consent from children >12 to 18 years of age.Sex as a biological variable not detected. Randomization A post hoc analysis of randomly selected serum samples (n = 24) was done to measure IgG1:IgG4 ratios … SciScore for 10.1101/2021.12.28.21268468: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The protocol was approved by the Institutional Ethics Committees at each study centre and the study was done in accordance with the revised Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013).
Consent: Eligible participants were healthy children of either gender from 2 to 18 years of age whose parents or legal guardians supplied written informed and audio-video consent; verbal assent was also obtained from children between 7 and 12 years of age, and written consent from children >12 to 18 years of age.Sex as a biological variable not detected. Randomization A post hoc analysis of randomly selected serum samples (n = 24) was done to measure IgG1:IgG4 ratios as an indicator of the balance of the Th1:Th2 responses [12,13]. Blinding not detected. Power Analysis The sample size was intended to allow separate comparisons of geometric mean neutralisation titres at Day 56 between each of the three age groups, and against titres observed in adults in a phase 2 study [14]. Table 2: Resources
Antibodies Sentences Resources We also measured the titres of IgG antibodies against the S-protein, receptor-binding domain (RBD), and nucleocapsid protein (N-protein) of SARS-CoV-2 by ELISA expressed as arbitrary ELISA units/mL. S-protein, receptor-binding domain (RBD), and nucleocapsid protein (N-proteinsuggested: NoneResults 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:The limitations of this study are mainly due to the ethical considerations of doing such a study in children, for which reason it was done open-label with no placebo arm. As such, we cannot compare the reactogenicity and immunogenicity results with a control arm. However, the low rates of reported reactogenicity except for injection site pain suggest that a control arm would not have revealed any medically significant issues. Transient mild-to-moderate injection site pain is the main adverse event reported by adults not only with BBV152 [3,13] but also with other COVID-19 vaccines [23,24]. Also, we have assessed only the immunogenicity of BBV152, not clinical efficacy, in children. In conclusion, the inactivated SARS-CoV-2 vaccine, BBV152, was well tolerated and immunogenic in children from 2 to 18 years of age, with neutralising antibody responses comparable to those observed in adults in whom the vaccine has been proven to be efficacious against symptomatic and asymptomatic COVID-19.
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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