Clinical trial NCT01474720: Zostavax in Systemic Lupus Erythematosus
Official title: Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Lupus
SLE
Zostavax
shingles
Lead sponsor: Oklahoma Medical Research Foundation
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

The investigators propose to study the immune response to commercially available Zostavax vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that seen in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the study are those felt to be safe according to Centers for Disease Control guidelines.

Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to receive a single, standard dose of Zostavax. Blood samples and physical examination will be performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants will receive active vaccine, there is no placebo group.


Eligibility 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).

Primary outcomes:
measure: Cell-mediated immune response to varicella at 12 weeks following vaccination
timeFrame: 12 weeks
Secondary outcomes:
measure: Antibody response to Zostavax vaccination
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
Study officials:
References:
citation: Guthridge JM, Cogman A, Merrill JT, Macwana S, Bean KM, Powe T, Roberts V, James JA, Chakravarty EF. Herpes zoster vaccination in SLE: a pilot study of immunogenicity. J Rheumatol. 2013 Nov;40(11):1875-80. doi: 10.3899/jrheum.130170. Epub 2013 Sep 15.