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Randomized Controlled Trial
. 2024 Mar;88(3):106133.
doi: 10.1016/j.jinf.2024.106133. Epub 2024 Mar 2.

Mycophenolate mofetil hampers antibody responses to a broad range of vaccinations in kidney transplant recipients: Results from a randomized controlled study

Z Al Fatly  1 , M G H Betjes  2 , W A Dik  3 , R A M Fouchier  4 , M E J Reinders  2 , A E de Weerd  2
Affiliations
Free article
Randomized Controlled Trial

Mycophenolate mofetil hampers antibody responses to a broad range of vaccinations in kidney transplant recipients: Results from a randomized controlled study

Z Al Fatly et al. J Infect. 2024 Mar.
Free article

Abstract

Objectives: To study the effect of mycophenolate mofetil (MMF) on various vaccination responses in kidney transplant recipients.

Methods: In a randomized controlled trial (EudraCT nr.: 2014-001372-66), low immunologically risk kidney transplant recipients were randomized to TAC/MMF or TAC-monotherapy (TACmono), six months post-transplantation. One year after transplantation, in a pre-specified sub-study, recipients were vaccinated against pneumococcus, tetanus and influenza. Blood was sampled before and 21 days after vaccination. Adequate vaccination responses were defined by international criteria. A post-hoc analysis was conducted on SARS-CoV-2 vaccination responses within the same cohort.

Results: Seventy-one recipients received pneumococcal and tetanus vaccines (TAC/MMF: n = 37, TACmono: n = 34), with 29 also vaccinated against influenza. When vaccinated, recipients were 60 (54-66) years old, with median eGFR of 54 (44-67) ml/min, tacrolimus trough levels 6.1 (5.4-7.0) ug/L in both groups and TAC/MMF daily MMF dose of 1000 (500-2000) mg. Adequate vaccination responses were: pneumococcal (TAC/MMF 43%, TACmono 74%, p = 0.016), tetanus (TAC/MMF 35%, TACmono 82%, p < 0.0001) and influenza (TAC/MMF 20%, TACmono 71%, p = 0.0092). Only 7% of TAC/MMF responded adequately to all three compared to 36% of TACmono (p = 0.080). Additionally, 40% of TAC/MMF responded inadequately to all three, whereas all TACmono patients responded adequately to at least one vaccination (p = 0.041). Lower SARS-CoV-2 vaccination antibody responses correlated with lower pneumococcal antibody vaccination responses (correlation coefficient: 0.41, p = 0.040).

Conclusions: MMF on top of tacrolimus severely hampers antibody responses to a broad range of vaccinations.

Keywords: 23-valent pneumococcal polysaccharide; Immunocompetence; Influenza; Kidney Transplantation; Mycophenolate mofetil; SARS-CoV-2; Tacrolimus; Tetanus; Vaccination.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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