Zostavax in Systemic Lupus Erythematosus

NCT01474720 | Completed Phase 1 DMC

• 1 other identifier: OMRF 11-45
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; Lupus; SLE; Zostavax; shingles

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• Antibody response to Zostavax vaccination

  12 weeks

• Adverse events

  12 weeks

Study Arms (2)

SLE patients

EXPERIMENTAL

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

Drug: Zostavax vaccine

Healthy subjects

ACTIVE COMPARATOR

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

Interventions

Zostavax vaccine DRUG

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.

Healthy subjects; SLE patients

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma Medical Research Foundation: lead

Study Sites (1)

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• 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.

  PMID: 24037550 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 18, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 17, 2013

Record last verified: 2011-11

Locations

US (1)