Efficacy of SARS-CoV-2 vaccination in patients with monoclonal gammopathies: A cross sectional study

  1. Eugenia Abella
  2. Macedonia Trigueros
  3. Edwards Pradenas
  4. Francisco Muñoz-Lopez
  5. Francesc Garcia-Pallarols
  6. Randa Ben Azaiz Ben Lahsen
  7. Benjamin Trinité
  8. Victor Urrea
  9. Silvia Marfil
  10. Carla Rovirosa
  11. Teresa Puig
  12. Eulàlia Grau
  13. Anna Chamorro
  14. Ruth Toledo
  15. Marta Font
  16. Dolors Palacín
  17. Francesc Lopez-Segui
  18. Jorge Carrillo
  19. Nuria Prat
  20. Lourdes Mateu
  21. Bonaventura Clotet
  22. Julià Blanco
  23. Marta Massanella
  24. VAC-COV-GM-HMAR, KING Cohort Extension and CoronAVI@S studies

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Abstract

SARS-CoV-2 vaccination is the most effective strategy to protect individuals with haematologic malignancies against severe COVID-19, while eliciting limited vaccine responses. We characterized the humoral responses following 3 mo after mRNA-based vaccines in individuals at different plasma-cell disease stages: monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and multiple myeloma on first-line therapy (MM), compared with a healthy population. Plasma samples from uninfected MM patients showed lower SARS-CoV-2–specific antibody levels and neutralization capacity compared with MGUS, SMM, and healthy individuals. Importantly, COVID-19 recovered MM individuals presented significantly higher plasma neutralization capacity compared with their uninfected counterparts, highlighting that hybrid immunity elicit stronger immunity even in this immunocompromised population. No differences in the vaccine-induced humoral responses were observed between uninfected MGUS, SMM and healthy individuals. In conclusion, MGUS and SMM patients could be SARS-CoV-2 vaccinated following the vaccine recommendations for the general population, whereas a tailored monitoring of the vaccine-induced immune responses should be considered in uninfected MM patients.

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  1. Version published to 10.26508/lsa.202201479
  2. ScreenIT

    SciScore for 10.1101/2022.01.19.22269531: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The VAC-COV-GM-HMAR, King cohort extension and CoronAVI@S studies were approved by the Ethics Committee Boards from the Hospital del Mar (HMAR), the Hospital Universitari Germans Trias i Pujol (HUGTIP) and the Institut Universitari d’Investigació en Atenció Primària (IDIAP) respectively (HMAR/2021/9913/I, HUGTiP/PI-20-217 and IDIAP/20-116P) and were conducted in accordance with the Declaration of Helsinki.
    Consent: All patients provided written informed consent before starting the study.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Determination of anti-SARS-CoV-2 antibodies: The presence of anti-SARS-CoV-2 antibodies against Spike S2 Subunit+ Spike protein receptor binding domain (S2+RBD) or Nucleocapside protein (NP) in plasma samples was evaluated using an in-house developed sandwich-ELISA, as previously described [13].
    anti-SARS-CoV-2
    suggested: None
    anti-SARS-CoV-2 antibodies against Spike S2 Subunit+ Spike protein receptor binding domain (S2+RBD) or Nucleocapside protein (NP
    suggested: None
    The impact of each variable to the levels of specific SARS-CoV-2 IgG or IgA antibodies and neutralization capacity was assessed via linear regression models including all patients with monoclonal gammopathies and the control groups, using the latter as reference.
    IgA
    suggested: None
    Software and Algorithms
    SentencesResources
    Standard curve was calculated by plotting and fitting the log of standard dilution (in arbitrary units) vs. response to a 4-parameter equation in Prism 8.4.3 (GraphPad Software).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    Statistical analyses were performed with Prism 9.1.2 (GraphPad Software) and R (4.1.2).
    Prism
    suggested: (PRISM, RRID:SCR_005375)

    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:
    Even though an assessment of the immune response several months after vaccination has been performed, our study has some limitations. First, the relatively small number of participants, especially for the uninfected MM group, limited the multivariate analysis especially for the impact of treatment. In addition, we did not assess specific SARS-CoV-2 cellular responses after vaccination, which could also be used as a correlate of protection [25]. In conclusion, patients suffering from MGUS and SMM did not show significant differences in the plasma neutralization capacity compared to healthy controls, and booster vaccine dose should be administrated following the recommendations for the general population. Because our results indicate that MM patients in first line of therapy have a blunted antibody response after three months from complete vaccine administration, a booster vaccine dose in this vulnerable population is essential to develop an adequate and effective humoral response. In addition, larger longitudinal studies are to carefully follow up the vaccine-induced immune responses to rightly develop tailored booster campaigns in these cancer patients and to adapt their SARS-CoV-2 vaccination calendar to their immune needs.

    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

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  3. Version published to 10.1101/2022.01.19.22269531v1 on medRxiv