Zostavax in Rheumatoid Arthritis
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | 50 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | October 2016 |
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.
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.
Inclusion Criteria:
- Age ≥ 50 years
- Willing and able to provide written informed consent
- History of primary varicella vaccination or positive VZV IgG antibodies
- Diagnosis of RA according to ACR criteria for > 1 year, or healthy control subject
- Stable, mild disease activity as defined by a DAS28 score of 4.0
- Current medical treatment for RA has been stable for 4 weeks prior to screening
- Acceptable immunosuppressive medications are limited to Prednisone ≤ 10 mg daily
Methotrexate ≤ 20 mg weekly Hydroxychloroquine ≤ 6.5 mg/kg daily Any TNF inhibitor
- Female subjects of childbearing potential and non-sterile males must agree to use
acceptable form of contraception for the duration of the study
Exclusion Criteria:
- History of receiving any VZV-containing vaccine
- History of herpes zoster reactivation (shingles) within 5 years of enrollment
- Received any vaccine within 6 weeks
- Known Hepatitis B, C or HIV virus infection
- History of drug or alcohol abuse within 1 year
- Rituximab therapy within 2 years of screening
- Cyclophosphamide within 6 months of screening
- Biologic therapy: TNF inhibitors with longer half-lives (infliximab, golimumab, etc),
or other non-TNF biologic therapies (IL-1 or IL-6 inhibition, or CTLA-4Ig)
- Use of mycophenolate mofetil within 3 months of screening
- History of receiving immunoglobulin or other blood product within 3 months of
screening
- Allergic reaction, intolerance or other contraindication to use of famciclovir.
- Has received an experimental/investigational agent (vaccine, drug, biologic, device,
blood product, or medication) within 3 months of screening; or expects to receive
another experimental/investigational agent within 6 months post immunization.
- Pregnant or lactating women
- Unwilling to use acceptable method of contraception for the duration of the study
- WBC <3.0; ANC <1500; CD4+ <200
- Proteinuria >1.5 mg/day
- Impaired renal function defined by serum Cr >1.5
- Transaminases > 2x upper limit of normal
- DAS28 > 4
- Anticipation of need to increase level of immunosuppression or add biologic therapy
for 6 months following dosing.
- History of neoplastic disease within 5 years of screening, except for completely
excised non-melanoma cancer of the skin or in-situ carcinoma of the uterine cervix.
- History of any hematological malignancy, current bleeding disorder or taking
anticoagulant medication (heparin or warfarin).
- Any condition that would, in the opinion of the site investigator, place the subject
at an unacceptable risk of injury or render the subject unable to meet the
requirements of the protocol.
We found this trial at
1
site
Oklahoma City, Oklahoma 73104
Principal Investigator: Eliza F Chakravarty, MD, MS
Phone: 405-271-6242
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