Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oklahoma Medical Research Foundation
Age
50–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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).
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