Real-world serological responses to extended-interval and heterologous COVID-19 mRNA vaccination in frail, older people (UNCoVER): an interim report from a prospective observational cohort study

  1. Donald C Vinh
  2. Jean-Philippe Gouin
  3. Diana Cruz-Santiago
  4. Michelle Canac-Marquis
  5. Stéphane Bernier
  6. Florian Bobeuf
  7. Avik Sengupta
  8. Jean-Philippe Brassard
  9. Alyssa Guerra
  10. Robert Dziarmaga
  11. Anna Perez
  12. Yichun Sun
  13. Yongbiao Li
  14. Lucie Roussel
  15. Mélanie J Langelier
  16. Danbing Ke
  17. Corey Arnold
  18. Marilyn Whelan
  19. Martin Pelchat
  20. Marc-André Langlois
  21. Xun Zhang
  22. Bruce D Mazer

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Abstract

No abstract available

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  1. Version published to 10.1016/s2666-7568(22)00012-5
  2. ScreenIT

    SciScore for 10.1101/2021.09.16.21263704: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This study was conducted in 12 LTC facilities of the Montréal Centre-Sud – Integrated University Health and Social Services Centre (CIUSSS du Centre-Sud-de-l’Île-de-Montréal) and was approved by its research ethics board (Comité d’éthique de la recherche Vieillissement-Neuroimagerie, protocol number 20-21-36 MP).
    Consent: Participating LTC elderly residents or their legally authorized representative provided informed consent before enrollment.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Assessment of SARS-CoV-2 antibody responses: Briefly, longitudinal serologic responses to vaccines were measured by automated chemiluminescent ELISA to detect IgG to SARS-CoV-2 trimeric spike (S), nucleoprotein (N) and the receptor binding domain (RBD) antigens to discriminate between vaccine-induced antibody response and convalescence from natural SARS-CoV-2 infection.
    SARS-CoV-2 trimeric spike (S), nucleoprotein (N) and the receptor binding domain (RBD)
    suggested: None

    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:
    One limitation of this study is the focus on IgG responses. Although immune correlates of protection against COVID-19 are not currently established, the spike protein-specific antibody responses (here, assessed by IgG to trimeric S and RBD antigens) generally correlate with the level of neutralizing antibody activity, which is thought to be a critical determinant of vaccine efficacy. Although the clinical relevance of induced, circulating IgA and IgM responses is less clear, we are currently evaluating these levels. As well, our study does not provide data on clinical effectiveness against infection or disease during the study period. Lastly, cellular immune responses were not included in this interim report, given the potential impact of our findings for nascent vaccination strategies in other countries, although those immunologic studies are ongoing. In frail elderly individuals, the use of mRNA-based vaccines against COVID-19 can be used with an extended interval of up to 16 weeks between doses. Neither age, sex, or comorbidity appears to impact these serological responses. Robust antibody levels are elicited with either mRNA-1273 or BNT162b2 as first dose, particularly in those with previously documented infection, although the latter vaccine is distinctly associated with a decline in antibody levels in the ensuing 16 weeks prior to the second dose. Under this dosing strategy, comparable antibody levels are achieved with either homologous or heterologous use of these vacc...

    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.

    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.

  3. Version published to 10.1101/2021.09.16.21263704v1 on medRxiv