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Zostavax in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01474720
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation

Study Description
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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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Zostavax vaccine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus
Study Start Date : November 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SLE patients
Subjects with mild SLE over age 50 years will receive open-label Zostavax vaccine.
 Drug: Zostavax vaccine
Commercially available Zostavax vaccine will be administered subcutaneously according to package insert guidelines. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV.
Active Comparator: Healthy subjects
Healthy subjects aged 50 years and older without any history of autoimmune disease will receive zostavax vaccine. Immune responses to varicella zoster virus and adverse events will be compared to those seen in SLE patients
 Drug: Zostavax vaccine
Commercially available Zostavax vaccine will be administered subcutaneously according to package insert guidelines. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV.


Outcome Measures
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Primary Outcome Measures :
  1. Cell-mediated immune response to varicella at 12 weeks following vaccination [ Time Frame: 12 weeks ]
    Peripheral blood will be drawn at baseline, then at 2,6, and 12 weeks following vaccination. Peripheral blood mononuclear cells will be assessed for measures of varicella-zoster specific immunity.


Secondary Outcome Measures :
  1. Antibody response to Zostavax vaccination [ Time Frame: 12 weeks ]
    Varicella specific IgG antibodies will be compared between baseline and 12 weeks post vaccination.

  2. Adverse events [ Time Frame: 12 weeks ]
    The development of adverse events, particularly injection site reactions or rash near the injection site will be tabulated and compared between SLE and healthy control groups


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474720


Locations
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United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Oklahoma Medical Research Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01474720    
Other Study ID Numbers: OMRF 11-45
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: November 2011
Keywords provided by Oklahoma Medical Research Foundation:
Systemic Lupus Erythematosus
Lupus
SLE
Zostavax
shingles
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases