Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial
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SciScore for 10.1101/2021.10.31.21265703: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Participants recruited from March 8 to March 31, 2021 by community family doctors provided written informed consent.
IRB: The Central Research Ethics Committee from the Cuban Ministry of Health was ad hoc appointed for this trial.Sex as a biological variable VE at the primary endpoint was evaluated across risk strata for severe disease (19-64 years without risk comorbidities; 19-64 years with risk comorbidities; and ≥65 years), sex (female or male), and skin color (white, black and mixed-race). Randomization Study Design, Oversight and Ethics: A double-blind, randomized, placebo-controlled, stratified Blinding Primary endpoint was judged blinded by COVID-19 hospital doctors, reviewed by … SciScore for 10.1101/2021.10.31.21265703: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Participants recruited from March 8 to March 31, 2021 by community family doctors provided written informed consent.
IRB: The Central Research Ethics Committee from the Cuban Ministry of Health was ad hoc appointed for this trial.Sex as a biological variable VE at the primary endpoint was evaluated across risk strata for severe disease (19-64 years without risk comorbidities; 19-64 years with risk comorbidities; and ≥65 years), sex (female or male), and skin color (white, black and mixed-race). Randomization Study Design, Oversight and Ethics: A double-blind, randomized, placebo-controlled, stratified Blinding Primary endpoint was judged blinded by COVID-19 hospital doctors, reviewed by specially trained doctors and finally by the study’s Principal Investigator (PI). Power Analysis The design required to achieve 90% power (and 2.5% 1-sided type I error) to detect a HR of 0.4 (VE >60% to reduce the risk of symptomatic disease compared to placebo), with a null hypothesis HR of 0.7. Table 2: Resources
No key resources detected.
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:The main limitation of this study— as of most phase 3, COVID19 VE studies— is the narrow time window for VE evaluation. The waning of immunity over time and its impact on efficacy are key aspects that deserve the highest attention. At present, we are following time evolution of protection as well as its behavior towards new circulating variants; these aspects will be addressed in other communications. In conclusion, the conjugate vaccine SOBERANA 02 was efficacious and induced cross-protection during a dominant circulation of the VOC β and VOC δ. The third heterologous dose of SOBERANA Plus increase efficacy up to an outstanding 92.4 % preventing severe disease and death. Taken together, our findings indicate that SOBERANA 02 is a promising vaccine that can be used in a two-dose regime or in heterologous three dose combination with SOBERANA plus to fight COVID19 pandemic in adults population. According to the safety profile and efficacy, it is a potential vaccine for pediatric age.
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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