Abstract Details

Title An Open-Label Observational Pilot Study To Evaluate the Safety and Immunogenicity of the Herpes Zoster Vaccine in Patients with Multiple Sclerosis

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 181

Objective

Background 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 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 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 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.

Authors/Disclosures
Corey A. McGraw, MD (Upstate Medical University) PRESENTER	The institution of Dr. McGraw has received research support from Novartis. The institution of Dr. McGraw has received research support from F. Hoffmann - La Roche. The institution of Dr. McGraw has received research support from Genentech. The institution of Dr. McGraw has received research support from Neurona Therapeutics. The institution of Dr. McGraw has received research support from Instituto Grifols, S.A..
Matilde Inglese, MD, PhD (University of Genoa)	Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SANOFI GENZYME. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIOGEN. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NOVARTIS. Dr. Inglese has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for MERCK-SERONO. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MS Journal.
Maria Petracca, PhD (University of Rome Sapienza)	Dr. Petracca has nothing to disclose.
Darin T. Okuda, MD, FAAN (UT Southwestern Medical Center)	Dr. Okuda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Okuda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cortechs AI. Dr. Okuda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Okuda has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Okuda has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Okuda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave Bioscience. Dr. Okuda has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Okuda has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Zenas BioPharma. The institution of Dr. Okuda has received research support from Novartis. The institution of Dr. Okuda has received research support from Alexion. Dr. Okuda has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
Aaron E. Miller, MD, FAAN (Mt Sinai School Of Med)	Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Accordant Health Services (Caremark). Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Corevitas (formerly known as Corrona). Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MAPI=Pharma. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Viatris (Mylan). Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gerson Lehrman Group. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen (Horizon Therapeutics). Dr. Miller has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Sterne Kessler. Dr. Miller has received publishing royalties from a publication relating to health care.

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