An Open-Label Observational Pilot Study To Evaluate the Safety and Immunogenicity of the Herpes Zoster Vaccine in Patients with Multiple Sclerosis (P01.181)

OBJECTIVE: To evaluate the safety and immunogenicity of the herpes zoster vaccine (HZV) in patients with multiple sclerosis (MS). BACKGROUND: Acute infections can precipitate exacerbations in MS leading to concerns that live attenuated virus vaccines may do so. HZV is approved in the US for patients aged >50 to reduce the risk of shingles/postherpetic neuralgia, but use in MS patients has not been evaluated. DESIGN/METHODS: An open-label observational pilot study was performed. All patients meeting eligibility requirements (age >50; history of varicella; EDSS 0-6.5; RR/SPMS; stable use of disease modifying agent; no prior use of mitoxantrone, fingolimod, or immunosuppressives) were offered enrollment. Primary endpoint: Change from baseline to 1-month post-vaccination MRI in number of enhancing lesions or increase in number/volume of T2 lesions. Secondary endpoints: Change in annualized relapse rate (ARR), number of relapses, disability progression, and increase in VZV antibody production. RESULTS: 19 subjects were enrolled. 18 completed two visits and 17 completed MRIs. Mean age 58.8; 13 F, 5 M; 12 RRMS, 6 SPMS. ARR for the 12 month pre-vaccination vs. 3 month post-vaccination period was 0.06 vs. 0. Median EDSS was 3.25 vs. 3.0 (p = 0.56). Baseline vs. 1 month post-vaccination MRI demonstrated no enhancing lesions, no new T2 lesions, and unchanged T1/T2 lesion volumes. VZV IgG levels increased from 3.26 to 5.13 (p=0.02). 7 adverse events: 4 mild injection site reactions, 1 mild arm bruising, 1 moderate bronchitis, and 1 incidental diagnosis of fibromuscular dysplasia. CONCLUSIONS: We believe this is the largest systematic observational study of the HZV in MS. There were no exacerbations, no new enhancing or T2 lesions, and no changes in T1 /T2 volumes. VZV IgG antibody levels increased indicating expected immunogenicity. Although this study was not designed to definitively establish safety, it provides evidence to suggest that the HZV may be safely administered in MS patients. Supported by: Grant from the Consortium of Multiple Sclerosis Centers. Disclosure: Dr. McGraw has received personal compensation for activities with Biogen Idec. Dr. Inglese has received personal compensation for activities with Celgene and Vaccinex. Dr. Petracca has nothing to disclose. Dr. Hannigan has nothing to disclose. Dr. Miller has received personal compensation for activities with Acorda Therapeutics, Biogen Idec, GlaxoSmithKline, Merck Serono, Novartis, Nuron Biotech, ONO, Genzyme/Sanofi, Questcor, Teva Neuroscience, and Accordant Health Services. Dr. Miller has received personal compensation for activities in an editorial capacity for Continuum and Continuum Audio. Dr. MIller has received research support from Acorda, Biogen Idec, Genentech, Genzyme/sanofi-aventis, Novartis, and Roche.