drugset / Trial / NCT01474720

Zostavax in Systemic Lupus Erythematosus

NCT01474720

Phase 1 Completed 20 enrolled Oklahoma Medical Research Foundation
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2011-11
Primary completion
2012-07
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Varivax Vaccine 0.65 ml Subcutaneous