Safety and Immune Response of a Live-Attenuated Herpes Zoster Vaccine in Patients With Systemic Lupus Erythematosus: A Randomised Placebo-Controlled Trial

Ann Rheum Dis. 2019 Dec;78(12):1663-1668. doi: 10.1136/annrheumdis-2019-215925. Epub 2019 Sep 17.

Abstract

Objectives: To study the safety and immunogenicity of a live-attenuated herpes zoster (HZ) vaccine in patients with systemic lupus erythematosus (SLE).

Methods: Adult SLE patients having a SLEDAI <6 and stable immunosuppressive treatment for ≥6 months were recruited. Participants were randomly assigned to receive HZ vaccine (Zostavax) or placebo injection. Anti-varicella zoster virus (VZV) IgG reactivity (baseline and week 6) was measured by an enzyme-linked fluorescence assay. Cell-mediated response was assessed by a VZV-stimulated interferon-gamma (IFN-γ) enzyme-linked ELISPOT assay. Adverse events and immune responses of the two groups were compared.

Results: 90 SLE patients were recruited (age 45.6±14.1 years; 93% women) and assigned to Zostavax or placebo (in 1:1 ratio). Baseline clinical parameters were similar between the two groups. The change in anti-VZV IgG from week 0 to 6 was +59.8% in the vaccine and -2.1% in the placebo group. Week 6 anti-VZV IgG was significantly higher in vaccinated than placebo-treated patients, after adjustment for baseline (4.16±1.26 vs 3.32±1.01; p<0.001). The number of IFN-γ secreting T-cell spots decreased in the placebo-treated patients (-17%) but increased in vaccinated patients (+42%). The T-cell spots number at week 6 was significantly higher in vaccine-than placebo-treated patients after adjustment for baseline (38.1±78.2 vs 23.1±47.9; p=0.02). Significantly more vaccinated patients reported self-limiting injection site reaction than controls (31% vs 7%; p<0.01). Two vaccinated patients (4.4%) and one (2.2%) placebo-treated patient had mild/moderate SLE flares but no patients developed HZ eruption within 6 weeks postvaccination.

Conclusions: In patients with stable SLE not receiving intensive immunosuppression, Zostavax was well-tolerated and provoked an immune response.

Trial registration number: US ClinicalTrials.gov registry (NCT02477150).

Keywords: herpes zoster; immunogenicity; live-attenuated; lupus; safety.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Follow-Up Studies
  • Herpes Zoster Vaccine / administration & dosage*
  • Herpesvirus 3, Human / immunology*
  • Humans
  • Immunoglobulin G / immunology
  • Injections, Subcutaneous
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lupus Erythematosus, Systemic / immunology
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome
  • Vaccination / methods*
  • Vaccines, Attenuated / administration & dosage*

Substances

  • Herpes Zoster Vaccine
  • Immunoglobulin G
  • Vaccines, Attenuated

Associated data

  • ClinicalTrials.gov/NCT02477150