Status:
COMPLETED
Zostavax in Systemic Lupus Erythematosus
Lead Sponsor:
Oklahoma Medical Research Foundation
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
Brief Summary
Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox....
Eligibility Criteria
Inclusion
- Age ≥ 50 years
- Willing and able to provide written informed consent
- History of primary varicella vaccination or positive VZV IgG antibodies
- Diagnosis of SLE according to ACR criteria for \> 1 year; or healthy control subject
- Stable, mild disease activity as defined by a clinical SLEDAI score ≤ 4
- Current medical treatment for SLE has been stable for 4 weeks prior to screening
- Acceptable immunosuppressive medications are limited to
- Prednisone ≤ 10 mg daily
- Methotrexate ≤ 20 mg weekly
- Azathioprine ≤ 150 mg daily
- Hydroxychloroquine ≤ 6.5 mg/kg daily
- Female subjects of childbearing potential and non-sterile males must agree to use acceptable form of contraception for the duration of the study
Exclusion
- History of receiving any VZV-containing vaccine (primary varicella or zoster)
- History of herpes zoster reactivation within 5 years prior to enrollment
- Received any live vaccine within 6 weeks or inactivated/recombinant vaccine within 2 weeks of enrollment
- Known Hepatitis B, C or HIV virus infection
- History of drug or alcohol abuse within 1 year of screening
- Rituximab therapy within 2 years of screening
- Cyclophosphamide within 6 months of screening
- Biologic therapy (TNF inhibitors, CTLA-4Ig, etc.) within 6 months of screening
- 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
- Clinical SLEDAI \> 4
- Active lupus nephritis or cerebritis
- 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.
- Has a moderate to severe acute illness and/or oral temperature greater or equal to 100.0oF, within 72 hours prior to vaccination (this may result in temporary delay of vaccination).
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01474720
Start Date
November 1 2011
End Date
October 1 2012
Last Update
September 17 2013
Active Locations (1)
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1
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104