title: Herpes zoster vaccination in SLE: a pilot study of immunogenicity.
abstract: OBJECTIVE
  Patients with systemic lupus erythematosus (SLE) are at increased risk of herpes zoster (HZ). Although a vaccine for HZ has been approved by the US Food and Drug Administration, its use in immunocompromised individuals remains controversial because it is a live-attenuated virus vaccine. We performed a pilot study of the immunogenicity of the HZ vaccine (Zostavax) in patients with SLE.
  
  
  METHODS
  Ten patients with SLE and 10 control subjects ≥ age 50 years participated in this open-label vaccination study. All were seropositive for varicella zoster virus (VZV). Patients with SLE were excluded for SLE Disease Activity Index (SLEDAI) > 4, or use of mycophenolate mofetil, cyclophosphamide, biologics, or > 10 mg prednisone daily. Followup visits occurred at 2, 6, and 12 weeks. Clinical outcomes included the development of adverse events, particularly HZ or vesicular lesions, and SLE flare. Immunogenicity was assessed with VZV-specific interferon-γ-producing enzyme-linked immunospot (ELISPOT) assays and with antibody concentrations.
  
  
  RESULTS
  All subjects were women. Patients with SLE were slightly older than controls (60.5 vs 55.3 yrs, p < 0.05). Median baseline SLEDAI was 0 (range 0-2) for patients with SLE. No episodes of HZ, vesicular rash, serious adverse events, or SLE flares occurred. Three injection site reactions occurred in each group: mild erythema or tenderness. The proportion of subjects with a > 50% increase in ELISPOT results following vaccination was comparable between both groups, although absolute SLE responses were lower than controls. Antibody titers increased only among controls following vaccination (p < 0.05).
  
  
  CONCLUSIONS
  The HZ vaccination yielded a measurable immune response in this cohort of patients with mild SLE taking mild-moderate immunosuppressive medications. No herpetiform lesions or SLE flares were seen in this small cohort of patients. ClinicalTrials.gov ID:NCT01474720.
authors.affiliation: From Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.
authors.forename: Joel M
authors.initials: JM
authors.lastname: Guthridge
authors.forename: Abigail
authors.initials: A
authors.lastname: Cogman
authors.forename: Joan T
authors.initials: JT
authors.lastname: Merrill
authors.forename: Susan
authors.initials: S
authors.lastname: Macwana
authors.forename: Krista M
authors.initials: KM
authors.lastname: Bean
authors.forename: Tiny
authors.initials: T
authors.lastname: Powe
authors.forename: Virginia
authors.initials: V
authors.lastname: Roberts
authors.forename: Judith A
authors.initials: JA
authors.lastname: James
authors.forename: Eliza F
authors.initials: EF
authors.lastname: Chakravarty
mesh_terms: D005260:Female; D006562:Herpes Zoster / Q000276:immunology / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000627:therapeutic use*; D014645:Herpesvirus 3, Human / Q000276:immunology*; D006801:Humans; D016867:Immunocompromised Host; D008180:Lupus Erythematosus, Systemic / Q000276:immunology* / Q000821:virology; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D053061:Herpes Zoster Vaccine
keywords: CLINICAL TRIAL; HERPES ZOSTER; INFECTION; SySTEMIC LUPUS ERyTHEMATOSUS; VACCINE; ZOSTAVAX
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