Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: A randomised, placebo-controlled, observer-blinded phase 1/2 trial
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
Abstract
Article activity feed
-
-
SciScore for 10.1101/2022.03.30.22273143: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was approved by the Institutional Review Board (IRB) of each participating hospital and was performed in accordance with the International Council for Harmonization Good Clinical Practice guidelines.
Consent: Written informed consent was obtained from all participants.Sex as a biological variable not detected. Randomization Study design and participants: This phase 1/2, randomized, placebo-controlled, observer-blinded, dose-escalating trial was conducted at 14 centers in South Korea Blinding not detected. Power Analysis not detected. 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 …
SciScore for 10.1101/2022.03.30.22273143: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was approved by the Institutional Review Board (IRB) of each participating hospital and was performed in accordance with the International Council for Harmonization Good Clinical Practice guidelines.
Consent: Written informed consent was obtained from all participants.Sex as a biological variable not detected. Randomization Study design and participants: This phase 1/2, randomized, placebo-controlled, observer-blinded, dose-escalating trial was conducted at 14 centers in South Korea Blinding not detected. Power Analysis not detected. 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 limitations of this study include the small sample size, especially for older adults, and short follow-up period. Nevertheless, the sample size provides a meaningful initial assessment of the frequency and intensity of the solicited AEs. As of January 31, 2022 (6 months post-vaccination), no AESI nor SAE related to vaccine have been reported. In conclusion, GBP510 adjuvanted with AS03 was well-tolerated with an acceptable safety profile, and highly immunogenic. The phase 1/2 trial has been extended to the homologous booster study, which assess the impact of a third dose (25μg GBP510 adjuvanted with AS03) on the durability and cross-protection. Based on the results of this phase 1/2 trial, a phase 3, randomized, observer-blind trial is underway to compare the immunogenicity and safety of 25 μg GBP510 adjuvanted with AS03 to ChAdOx1 in adults 18 years of age and older (initiated August 30, 2021). In addition, a Phase 2, heterologous GBP510 adjuvanted with AS03 booster trial began on January 6, 2022, to assess the merits of this immune-focused antigen as a universal booster to already licensed CoV-2 vaccines.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04750343 Active, not recruiting Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle V… 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.
-
