These studies focus on the safety of vaccine and protein immunogens. We are interested in learning what forms of immunization can initiate, perpetuate or magnify autoimmune responses. Our work uses normal and disease-prone animals to monitor the effect of various vaccines on autoantibody production and disease severity. We are also interested in learning what changes in immune system function contribute to the development of systemic autoimmunity. Thus, we are analyzing the effect of cytokines and sex hormones on the level and type of immune activation in normal individuals and those with autoimmune disease. Finally, our lab is examining potential therapies for established autoimmune disease. A critical element in the assessment of vaccine safety is their potential to induce or augment the development of autoimmune disease. Our studies are directed towards identifying those factors that are responsible for eliciting systemic autoimmunity. In addition, our studies of patients with lupus are of particular importance to the FDA Office of Woman's Health, which selected this project for support.