mRNA COVID-19 vaccine booster fosters B- and T-cell responses in immunocompromised patients

  1. Elena Azzolini
  2. Chiara Pozzi
  3. Luca Germagnoli
  4. Bianca Oresta
  5. Nicola Carriglio
  6. Mariella Calleri
  7. Carlo Selmi
  8. Maria De Santis
  9. Silvia Finazzi
  10. Carmelo Carlo-Stella
  11. Alexia Bertuzzi
  12. Francesca Motta
  13. Angela Ceribelli
  14. Alberto Mantovani
  15. Fabrizio Bonelli
  16. Maria Rescigno

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Abstract

SARS-CoV-2 vaccination has proven effective in inducing an immune response in healthy individuals and is progressively us allowing to overcome the pandemic. Recent evidence has shown that response to vaccination in some vulnerable patients may be diminished, and it has been proposed a booster dose. We tested the kinetic of development of serum antibodies to the SARS-CoV-2 Spike protein, their neutralizing capacity, the CD4 and CD8 IFN-γ T-cell response in 328 subjects, including 131 immunocompromised individuals (cancer, rheumatologic, and hemodialysis patients), 160 health-care workers (HCW) and 37 subjects older than 75 yr, after vaccination with two or three doses of mRNA vaccines. We stratified the patients according to the type of treatment. We found that immunocompromised patients, depending on the type of treatment, poorly respond to SARS-CoV-2 mRNA vaccines. However, an additional booster dose of vaccine induced a good immune response in almost all of the patients except those receiving anti-CD20 antibody. Similarly to HCW, previously infected and vaccinated immunocompromised individuals demonstrate a stronger SARS-CoV-2–specific immune response than those who are vaccinated without prior infection.

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  1. Version published to 10.26508/lsa.202201381
  2. Version published to 10.1101/2022.01.21.22269633v2 on medRxiv
  3. ScreenIT

    SciScore for 10.1101/2022.01.21.22269633: (What is this?)

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

    Table 1: Rigor

    EthicsField Sample Permit: The studies were conducted at Istituto Clinico Humanitas and comprised a longitudinal sample collection, including healthcare workers (n=160) and cancer patients (n=30) and a cross-sectional sample collection, including elderly subjects (n=37), patients with rheumatic diseases (n=48) and patients in hemodialysis (n=53).
    Consent: Study inclusion criteria included a vaccination with an authorized COVID-19 vaccine (according to Italian regulation and guidelines), age of 18 years or greater, and willingness and ability to provide informed consent.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingExperiments were conducted in a blinded fashion with designated members of the clinical team, who did not run the assays, having access to the sample key until data were collected, at which point researchers of the team were unblinded.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Study design: We tested the IgG antibody response, the CD4 and CD8 T cell activation and the neutralizing antibody response to SARS-CoV-2 spike protein developed after mRNA SARS-CoV-2 vaccination (Spikevax or Moderna mRNA-1273 – Comirnaty or BNT162b2 Pfizer-BioNTech) as a part of two observational studies approved by the Ethical Committee of Istituto Clinico Humanitas, in compliance with the Declaration of Helsinki principles.
    CD4
    suggested: None
    Following the definition of the WHO International Standard for anti-SARS-CoV-2 Immunoglobulin (NIBSC 20:136), the readout was updated and the assay currently calculates the levels of SARS-CoV-2 IgG antibodies in binding antibody units (BAU/mL) (Perkmann et al., 2021).
    anti-SARS-CoV-2
    suggested: None
    SARS-CoV-2 IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Data analyses were carried out using GraphPad Prism version 8.
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    Results from OddPub: Thank you for sharing your data.

    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.

  4. Version published to 10.1101/2022.01.21.22269633v1 on medRxiv