Idiotypic vaccination with a murine anti-dsDNA antibody: Phase I study in patients with nonactive systemic lupus erythematosus with nephritis

Objective, To determine the safety and immunogenicity of an idiotypic anti- dsDNA vaccine in patients with nonactive systemic lupus erythematosus (SLE) and stable lupus nephritis, Methods. Patients with SLE with a history of nephritis were randomized for vaccination with the murine anti-dsDNA monoclonal antibody (Mab) 3E10 in a dose ranging, double blind, placebo controlled study (phase I). Results. Of the 9 patients injected with Mab 3E10, 5 showed a human anti-mo use antibody (HAMA) response, in large part antiidiotypic, which developed within the first 3 months in 3 strong HAMA responders, and more than one ye ar after immunization in an initially weak HAMA responder, All but one nonr esponder were receiving low dose prednisone. No adverse events, in particul ar no evidence of lupus flares. and no untoward laboratory findings were re ported over a followup of 2 years. Conclusion. In patients with stable lupus nephritis, immunization with Mab 3E10 appears safe and can generate a significant antiidiotypic response. Id iotypic vaccination may be an approach to specific immunotherapy of autoimm une lupus nephritis.