NCT01474720

Zostavax in Systemic Lupus Erythematosus

Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Oklahoma Medical Research Foundation · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2011-11-18
• Last updated: 2013-09-17

Locations

1 site across 1 country: United States