Zostavax in Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01474720
First received: November 15, 2011
Last updated: September 16, 2013
Last verified: November 2011
  Purpose

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 Intervention Phase
Systemic Lupus Erythematosus
Drug: Zostavax vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Oklahoma Medical Research Foundation:

Primary Outcome Measures:
  • Cell-mediated immune response to varicella at 12 weeks following vaccination [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Antibody response to Zostavax vaccination [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Varicella specific IgG antibodies will be compared between baseline and 12 weeks post vaccination.

  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01474720

Locations
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Oklahoma Medical Research Foundation
  More Information

No publications provided by Oklahoma Medical Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01474720     History of Changes
Other Study ID Numbers: OMRF 11-45
Study First Received: November 15, 2011
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma Medical Research Foundation:
Systemic Lupus Erythematosus
Lupus
SLE
Zostavax
shingles

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014