Pre-exposure prophylaxis with Evusheld™ elicits limited neutralizing activity against the omicron variant in kidney transplant patients

  1. Ilies Benotmane
  2. Aurélie Velay
  3. Olivier Thaunat
  4. Gabriela Gautier Vargas
  5. Jérôme Olagne
  6. Samira Fafi-Kremer
  7. Sophie Caillard

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Abstract

The combination of cilgavimab-tixagevimab (Evusheld™, Astra Zeneca) became the mainstay for protecting transplant recipients with poor response to vaccination against the omicron variant. Serum neutralizing capacity against SARS-CoV-2 is positively associated with protection against severe forms of Covid-19.

Both anti-RBD IgG titers and neutralizing antibody titers against the omicron BA.1 variant were measured in serum samples collected from 63 adult kidney transplant recipients who received prophylactic injections of Evusheld™. Patients who received prophylactic Ronapreve™ (casirivimab-imdevimab, n = 39) and those who were infected with SARS-CoV-2 during the fifth wave of the pandemic (n = 14) served as negative and positive controls, respectively.

After a median interval from injection of 29 days (interquartile range 29-33 days), only 9.5% of patients who received Evusheld™ were able to neutralize the omicron variant compared to 71% of patients who were infected with SARS-CoV-2 and 2.6% of those who received Ronapreve™. Interestingly, convalescent patients displayed higher levels of neutralizing antibodies than those who received EvusheldTM (median: 2.3 log IC50, IQR: 1.5-2.7 versus 0.00 log IC50, IQR: 0&[ndash] 0.05; p<0.001). A high interindividual variability in anti-RBD IgG titers was observed after Evusheld™ (range: 262-7032 BAU/mL). This variability was largely explained by the patients’body mass index, which showed an inverse correlation with anti-RBD IgG titers.

These findings suggest that Evusheld™ given at a dose of 300 mg is not sufficient to elicit an anti-RDB titer that confers in vivo neutralizing activity and support recent FDA recommendations, derived from in vitro models, regarding the need to increase the dose of Evusheld™

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    SciScore for 10.1101/2022.03.21.22272669: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    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).

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    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
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    • Thank you for including a protocol registration statement.

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  2. Version published to 10.1101/2022.03.21.22272669 on medRxiv