A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the
safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including
patients with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel
disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases.

Inclusion Criteria:

- Diagnosed with an autoimmune disease

- Clinically stable disease for at least 30 days before enrollment

- Not likely to undergo hematopoietic stem cell transplantation during the study period

- Receiving at least one parenteral or oral biologic agent, such as a TNF alpha
inhibitor, or a parenteral or oral non-biologic therapy, at a stable dose for at
least 3 months, with no planned or anticipated changes

- History of varicella, antibodies to VZV, or residence for at least 30 years in a
country with endemic VZV infection, or if participant is less than 30 years old,
attended primary or secondary school in a country with endemic VZV infection

Exclusion Criteria:

- Prior history of Herpes Zoster (shingles) within 1 year before enrollment

- Prior varicella or zoster vaccine

- Active central nervous system lupus erythematosus requiring therapeutic intervention
within 90 days of enrollment

- Prior or planned therapy containing rituximab or other anti-CD20 monoclonal
antibodies from 3 months before enrollment through 28 days postdose 4

- Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the
time of enrollment