1. SciScore for 10.1101/2021.02.26.21252482: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: All participants provided written informed consent prior to trial enrollment.
    IRB: The trial protocol was approved by the Alfred Hospital Human Research Ethics Committee (Melbourne, Australia) and Advarra Central Institutional Review Board (Colombia, Maryland, USA) and was performed in accordance with the International Conference on Harmonisation, Good Clinical Practice guidelines.
    RandomizationApproximately 750 participants were planned to be randomized in each country.
    BlindingEligible participants were randomly assigned (1:1:1:1:1) in a blinded manner to one of five vaccine groups (groups A, B, C, D, and E) according to pre-generated randomization schedules with two-factor, two-level stratification employed (ages 18-59 and 60-84 years; study site) (Fig. 1).
    Power AnalysisWith at least 150 participants in each vaccine group, there was more than adequate power to detect differences in IgG anti-spike protein responses and safety data between vaccine groups.
    Sex as a biological variableEligible participants were men and non-pregnant women 18 to 84 years of age with a body mass index (the weight in kilograms divided by the square of the height in meters) of 17 to 35.

    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: 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:

    IdentifierStatusTitle
    NCT04368988Active, not recruitingEvaluation 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.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

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  2. Our take

    Vaccines using the nanoparticle/Matrix-M1 adjuvant approach, like NVX-CoV2373 (Novavax), have been widely studied and have a very acceptable safety profile. This phase 2 trial report, available as a preprint and thus not yet peer-reveiwed, found that both the 5ug and 25ug doses of NVX-CoV2373 were effective at inducing production of IgG and neutralizing antibodies, while the 25ug dose had a higher incidence of local reactogenicity in both younger and older adults. Therefore, Novavax will move forward with a 2-dose regimen of 5ug NVX-CoV2373 administered 21 days apart in phase 3 trials. Trials are currently ongoing in South Africa, the UK, the US, and Mexico.

    Study design

    randomized-controlled-trial

    Study population and setting

    This paper described the phase 2 trial of the Novavax vaccine, NVX-CoV2373, which is composed of trimeric full-length SARS-CoV-2 spike proteins and adjuvant. The trial took place between August 24 and September 25, 2020. 1283 participants in two age groups were studied: younger (18-59 years) and older (60-84 years) adults, at nine sites in Australia and eight sites in the US. Participants received either one or two doses of 5ug or 25ug NVX-CoV2373 or placebo 21 days apart. Immunogenicity and safety data were studied through day 35, including adverse events, reactogenicity within 7 days of receiving the vaccine, IgG response, and neutralizing antibody production.

    Summary of main findings

    The most commonly reported local adverse events were pain and tenderness at the injection site, while the most common systemic adverse events were muscle pain, fatigue, headache, and malaise. Fever was only reported in less than 2% of all participants. Reactogenicity occurred at higher frequency in younger participants compared to older participants, and the systemic reactions were also more common after the second dose. Seroconversion rates of IgG production were 99% and 100% (younger participants) and 97% and 99% (older participants) after 2 doses of 5ug or 25ug, respectively. Additionally, seroconversion of neutralizing antibodies were 100% and 100% (younger participants) and 100% and 96% (older participants) after 2 doses of 5ug or 25ug, respectively. Higher amounts of neutralizing antibodies were detected in both younger and older participants compared to convalescent sera.

    Study strengths

    This vaccine uses a recombinant protein approach, which is different than the other already approved COVID-19 vaccines, making it novel. This trial studied multiple doses and dosing regimens for NVX-CoV2373, and also included both younger and older adults.

    Limitations

    The study included 87% white participants. Future trials for NVX-CoV2373 included a more diverse population in South Africa and Mexico, but these data are not reported here. No analysis of T-cells was included here, only study of antibodies, even though no true correlate of vaccine protection has been defined. Finally, data was only published here for observations through day 35, so no-long term data is provided yet.

    Value added

    First report of phase 2 results from the Novavax NVX-CoV2373 vaccine, with results in both younger and older adults

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