Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial
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SciScore for 10.1101/2021.12.23.21267374: (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 Alfred Hospital Ethics Committee (Melbourne, Victoria, Australia) and Advarra Central Institutional Review Board (Colombia, Maryland, USA) and is registered on Clinicaltrials.gov (NCT04368988).
Consent: Participants were eligible if they had a body mass index of 17 to 35 kg/m2, were able to provide informed consent prior to enrollment, and (for female participants) agreed to remain heterosexually inactive or use approved forms of contraception.Sex as a biological variable Participants: Healthy male and female participants ≥ 18 to ≤ 84 years of age were recruited for enrollment in this study. Randomization Study Design: A single booster dose was … SciScore for 10.1101/2021.12.23.21267374: (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 Alfred Hospital Ethics Committee (Melbourne, Victoria, Australia) and Advarra Central Institutional Review Board (Colombia, Maryland, USA) and is registered on Clinicaltrials.gov (NCT04368988).
Consent: Participants were eligible if they had a body mass index of 17 to 35 kg/m2, were able to provide informed consent prior to enrollment, and (for female participants) agreed to remain heterosexually inactive or use approved forms of contraception.Sex as a biological variable Participants: Healthy male and female participants ≥ 18 to ≤ 84 years of age were recruited for enrollment in this study. Randomization Study Design: A single booster dose was administered to participants as part of an ongoing phase 2, randomized, observer-blinded, placebo-controlled study of NVX-CoV2373. Blinding All vaccinations were prepared and administered on an outpatient basis by designated site personnel in a way to maintain the blind. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Assays: Measures of immune response included assays for serum immunoglobulin G (IgG) antibodies, neutralizing antibody activity (microneutralization assay at an inhibitory concentration >50% [MN50]), and human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition. IgGsuggested: NoneSerum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen were detected using a qualified or validated IgG ELISA (Novavax Clinical Immunology, Gaithersburg, MD, US) for the ancestral strain and Beta variant, respectively SARS-CoV-2 rS proteinsuggested: NoneResults from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:With the caveat that the data are drawn from different studies, it appears that the reactogenicity rates seen after a third dose of NVX-CoV2373 are generally similar to those seen with a booster dose of the Pfizer/BioNtech and Moderna vaccines and elevated compared to the Oxford/AstraZeneca vaccine (Flaxman 2021, Choi 2021, FDA 2021). While the incidence of unsolicited adverse events following the booster was higher in vaccine recipients (12.4%) compared to placebo recipients (11.0%), all events were classified as mild or moderate in severity. Medically attended adverse events, PIMMCs, and SAEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups. Our study was subject to certain limitations. As these results are from an ongoing phase 2 study conducted with a limited sample size, clinical efficacy of the booster dose was not evaluated. In addition, between-strain comparisons of antibody data should be made with caution, as correlations with clinical efficacy may vary for each variant of COVID-19. Overall, a single booster dose of NVX-CoV2373 administered approximately 6 months after the primary series induced a substantial increase in humoral antibodies that was > 4-fold higher than antibody titers associated with high levels of efficacy in two phase 3 studies while also displaying an acceptable safety profile. These findings support use of the vaccine in booster programs.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04368988 Active, not recruiting Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 … 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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