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).
- herpes zoster
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Handling editor Josef S Smolen
Contributors CCM and LYH: study design, patients’ assessment, data collection and analysis. KHC, YFF, WFF and PCYW: laboratory assay, data collection and analysis.
Funding This work was funded by the Health and Medical Research Fund from the Hong Kong Research Fund Secretariat.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study protocol was approved by the Research and Ethics Committee of Tuen Mun Hospital and registered in ClinicalTrial.Gov (NCT02477150).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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