Zostavax in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01474720
• Date of registration: 15/11/2011
• Prospective Registration: No
• Primary sponsor: Oklahoma Medical Research Foundation
• Public title: Zostavax in Systemic Lupus Erythematosus
• Scientific title: Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus
• Date of first enrolment: November 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01474720
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

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 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 Criteria:

- 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).



Age minimum: 50 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Zostavax vaccine

Primary Outcome(s)

Cell-mediated immune response to varicella at 12 weeks following vaccination [Time Frame: 12 weeks]

Secondary Outcome(s)

Adverse events [Time Frame: 12 weeks]

Antibody response to Zostavax vaccination [Time Frame: 12 weeks]

Secondary ID(s)

OMRF 11-45

Source(s) of Monetary Support

Please refer to primary and secondary sponsors