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Zostavax in Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zostavax vaccine
Sponsored by
Oklahoma Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, Lupus, SLE, Zostavax, shingles

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Oklahoma Medical Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SLE patients

Healthy subjects

Arm Description

Subjects with mild SLE over age 50 years will receive open-label Zostavax vaccine.

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

Outcomes

Primary Outcome Measures

Cell-mediated immune response to varicella at 12 weeks following vaccination
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
Varicella specific IgG antibodies will be compared between baseline and 12 weeks post vaccination.
Adverse events
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

Full Information

First Posted
November 15, 2011
Last Updated
September 16, 2013
Sponsor
Oklahoma Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01474720
Brief Title
Zostavax in Systemic Lupus Erythematosus
Official Title
Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma Medical Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, Lupus, SLE, Zostavax, shingles

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLE patients
Arm Type
Experimental
Arm Description
Subjects with mild SLE over age 50 years will receive open-label Zostavax vaccine.
Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Zostavax vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cell-mediated immune response to varicella at 12 weeks following vaccination
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Antibody response to Zostavax vaccination
Description
Varicella specific IgG antibodies will be compared between baseline and 12 weeks post vaccination.
Time Frame
12 weeks
Title
Adverse events
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24037550
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.
Results Reference
derived

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Zostavax in Systemic Lupus Erythematosus

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