Adjuvanted recombinant zoster vaccine in adult autologous stem cell transplant recipients: polyfunctional immune responses and lessons for clinical practice

Edward A. Stadtmauer, Keith M. Sullivan, Mohamed El Idrissi, Bruno Salaun, Aránzazu Alonso Alonso, Charalambos Andreadis, Veli Jukka Anttila, Adrian J.C. Bloor, Raewyn Broady, Claudia Cellini, Antonio Cuneo, Alemnew F. Dagnew, Emmanuel Di Paolo, Hyeon Seok Eom, Ana Pilar González-Rodríguez, Andrew Grigg, Andreas Gunther, Thomas C. Heineman, Isidro Jarque, Jae Yong KwakAlessandro Lucchesi, Lidia Oostvogels, Marta Polo Zarzuela, Anne E. Schuind, Thomas C. Shea, Ulla Marjatta Sinisalo, Filiz Vural, Lucrecia Yáñez San Segundo, Pierre Zachée, Adriana Bastidas

Research output: Contribution to journalArticleScientificpeer-review

Abstract

Immunocompromised individuals, particularly autologous hematopoietic stem cell transplant (auHSCT) recipients, are at high risk for herpes zoster (HZ). We provide an in-depth description of humoral and cell-mediated immune (CMI) responses by age (protocol-defined) or underlying disease (post-hoc) as well as efficacy by underlying disease (post-hoc) of the adjuvanted recombinant zoster vaccine (RZV) in a randomized observer-blind phase III trial (ZOE-HSCT, NCT01610414). 1846 adult auHSCT recipients were randomized to receive a first dose of either RZV or placebo 50–70 days post-auHSCT, followed by the second dose at 1–2 months (M) later. In cohorts of 114–1721 participants, at 1 M post-second vaccine dose: Anti-gE antibody geometric mean concentrations (GMCs) and median gE-specific CD4[2+] T-cell frequencies (CD4 T cells expressing ≥2 of four assessed activation markers) were similar between 18–49 and ≥50-year-olds. Despite lower anti-gE antibody GMCs in non-Hodgkin B-cell lymphoma (NHBCL) patients, CD4[2+] T-cell frequencies were similar between NHBCL and other underlying diseases. The proportion of polyfunctional CD4 T cells increased over time, accounting for 79.6% of gE-specific CD4 T cells at 24 M post-dose two. Vaccine efficacy against HZ ranged between 42.5% and 82.5% across underlying diseases and was statistically significant in NHBCL and multiple myeloma patients. In conclusion, two RZV doses administered early post-auHSCT induced robust, persistent, and polyfunctional gE-specific immune responses. Efficacy against HZ was also high in NHBCL patients despite the lower humoral response.

Original languageEnglish
JournalHUMAN VACCINES & IMMUNOTHERAPEUTICS
DOIs
Publication statusE-pub ahead of print - Aug 2021
Publication typeA1 Journal article-refereed

Keywords

  • adjuvanted recombinant zoster vaccine
  • Autologous hematopoietic stem cell transplant
  • cell-mediated immunity
  • humoral immune response
  • polyfunctionality
  • vaccine efficacy

Publication forum classification

  • Publication forum level 1

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

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