Effectiveness and Durability of mRNA Vaccine-Induced SARS-CoV-2-Specific Humoral and Cellular Immunity in Severe Asthma Patients on Biological Therapy

  1. Michal Podrazil
  2. Pavla Taborska
  3. Dmitry Stakheev
  4. Michal Rataj
  5. Jan Lastovicka
  6. Alena Vlachova
  7. Petr Pohunek
  8. Jirina Bartunkova
  9. Daniel Smrz

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Abstract

Coronavirus disease 2019 (COVID-19) vaccines effectively elicit humoral and cellular immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy populations. This immunity decreases several months after vaccination. However, the efficacy of vaccine-induced immunity and its durability in patients with severe asthma on biological therapy are unknown. In this study, we evaluated the effectiveness and durability of mRNA vaccine-induced SARS-CoV-2-specific humoral and cellular immunity in severe asthma patients on biological therapy. The study included 34 patients with severe asthma treated with anti-IgE (omalizumab, n=17), anti-IL5 (mepolizumab, n=13; reslizumab, n=3), or anti-IL5R (benralizumab, n=1) biological therapy. All patients were vaccinated with two doses of the BNT162b2 mRNA vaccine with a 6-week interval between the doses. We found that this COVID-19 vaccination regimen elicited SARS-CoV-2-specific humoral and cellular immunity, which had significantly declined 6 months after receipt of the second dose of the vaccine. The type of biological treatment did not affect vaccine-elicited immunity. However, patient age negatively impacted the vaccine-induced humoral response. On the other hand, no such age-related impact on vaccine-elicited cellular immunity was observed. Our findings show that treatment of patients with severe asthma with biological therapy does not compromise the effectiveness or durability of COVID-19 vaccine-induced immunity.

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  1. Version published to 10.3389/fimmu.2022.892277
  2. ScreenIT

    SciScore for 10.1101/2022.02.17.22271122: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Each patient provided signed written informed consent for the use of their blood-derived products for future research.
    IRB: The study was approved according to the ethical standards of the institutional research committee – the Ethics Committee of the Motol University Hospital in Prague (EK-346/21), and performed in compliance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Determination of the serum levels of anti-SARS-CoV-2 antibodies: The patients’ sera were analyzed for the presence of anti-SARS-CoV-2 antibodies.
    anti-SARS-CoV-2
    suggested: None
    Anti-SARS-CoV-2-spike glycoprotein receptor-binding domain (RBD) IgA and IgG antibodies were determined using IVD EIA COVID-19 RBD IgA or IgG (TestLine Clinical Diagnostics, Brno, Czech Republic).
    Anti-SARS-CoV-2-spike glycoprotein receptor-binding domain (RBD) IgA
    suggested: None
    IgG antibodies
    suggested: None
    Anti-SARS-CoV-2 nucleocapsid protein (NCP) IgG antibodies were determined using CLIA COVID-19 NP IgG (TestLine Clinical Diagnostics).
    Anti-SARS-CoV-2 nucleocapsid protein (NCP) IgG
    suggested: None
    After the stimulation, the cells were stained with fixable live/dead stain, fixed, permeabilized, and stained with fluorescent-tagged CD3-, CD4-, CD8-, IFN-γ-, and TNF-α-specific antibodies as described (40).
    CD8-
    suggested: None
    IFN-γ-
    suggested: None
    TNF-α-specific
    suggested: None
    Software and Algorithms
    SentencesResources
    FlowJo software (Tree Star, Ashland, OR) was used to analyze the acquired flow cytometry data.
    FlowJo
    suggested: (FlowJo, RRID:SCR_008520)
    Statistical Analysis: The values were calculated from the indicated sample size (n) using GraphPad Prism 6 (GraphPad Software, La Jolla, CA).
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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: 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 10.1101/2022.02.17.22271122v1 on medRxiv