Background/Purpose:   The Zostavax vaccine was FDA approved in 2006 for the prevention of herpes zoster in healthy adults over age 50.  Because it is a live-attenuated vaccine, concerns exist regarding the safety of vaccination in individuals with autoimmune diseases and those on immunosuppressive therapies.  We sought to evaluate the safety and immunogenicity of Zostavax vaccination in a group of SLE patients compared to healthy control subjects.

Methods:   Ten SLE patients and ten healthy control subjects, all older than 50 years, were recruited to receive Zostavax vaccination followed by 12 weeks of follow-up for safety and immunogenicity.  All study subjects had serologic confirmation of primary varicella infection before vaccination. SLE patients had mild, stable disease, with SLEDAI ≤ 4 at enrollment.  SLE medications were restricted to azathioprine, methotrexate, anti-malarials, and ≤ 10 mg prednisone daily.  Exclusion criteria included history of any varicella vaccination, herpes zoster within 5 years, and use of mycophenolate mofetil, cyclophosphamide or biologic therapies within 6 months of enrollment.

Each subject received Zostavax subcutaneously in the deltoid region during the baseline visit.  Follow-up visits were scheduled at 2, 6, and 12 weeks following vaccination for safety and efficacy assessments.  The primary safety endpoint was development of herpetiform or bullous lesions at the injection site at any time.  Secondary safety endpoints were SLE flare by SLEDAI flare index, any injection site reaction, and any treatment-related adverse events.  Primary immunogenicity endpoint was change in VZV-specific cell mediated immunity at 6 weeks compared to baseline between groups.  Secondary endpoints included changes in WBC subsets by FACs analysis at each time point.

Results:  All study participants were women.  Baseline demographics are outlined in Table 1.Among SLE patients, mean baseline SLEDAI was 1.1 (range 0-2).  Four patients were receiving prednisone (range 2.5-10 mg daily), two, methotrexate, and seven hydroxychloroquine.  All subjects received Zostavax vaccination and have completed at least 6 weeks of follow-up, and 13 have completed the 12 week study.  No episodes of herpes zoster, bulliform lesions at the injection site, serious AEs, or SLE flares occurred during the study.  Three subjects in each group experienced injection site reactions of erythema or tenderness.  All were mild and transient.  Mean change in SLEDAI score at six weeks was 0.2. Proportions of leukocyte subsets or plasmacytoid dendritic cells were not significantly changed following vaccination in either group. Functional varicella response cellular assays will be performed on batched samples once all 12-week visits have been completed.

Conclusion:   Zostavax vaccination appears to be well tolerated in this cohort of patients with mild SLE on mild to moderate immunosuppressive therapy.

Table 1:  Demographic and Safety Outcomes

	SLE	Healthy
n	10	10
Age,  mean (SD)	60.5 (5.4)	55.3 (4.2)
European American	7	7
African American	3	3
h/o shingles	4	2
Taking prednisone	4	–
mean daily dose	6.9 mg	–
Taking HCQ	7	–
Taking MTX	2	–
Baseline SLEDAI	1.1 (0.99)	–
ISR (any), n	3	3
Erythema, tenderness	3	3
Vesicular	0	0
6 week SLEDAI	1.3 (1.2)	–
mean Δ SLEDAI	0.2 (1.5)	–
SLE flare	0	–

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