Rheumatoid Arthritis Clinical Trial
Official title:
Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis
Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV)
that usually occurs decades following initial exposure. The risk of developing shingles
increases with age. Shingles presents as a painful, itchy blistering rash that usually
involves a single portion of the skin and lasts about 7-10 days. The risk of developing
shingles increases with age in healthy people, and has been shown in some studies to be
increased in people with rheumatoid arthritis and other autoimmune diseases.
Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by
the FDA for the prevention of Shingles among people 60 years and older, and is now approved
for use in people aged 50 years and older. Because rheumatoid arthritis and some of the
medications used to treat rheumatoid arthritis can impair the body's immune system, it is not
known how much of an immune response can be generated in people with rheumatoid arthritis.
The goals of this study are to measure the immune response after standard vaccination with
Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune
systems. All participants will be 50 years old or older, and subjects with rheumatoid
arthritis will not be eligible if they are taking certain biologic medications, including TNF
inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid
arthritis will all receive a single vaccination with Zostavax, then will be followed for 12
weeks to assess the immune response and for the development of local rash or other potential
side effects.
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