INTRAMUSCULAR VACCINE W/ALUM ADJUVANT OF DR4/1 PEPTIDE IN RHEUMATOID ARTHRITIS

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This prospective, randomized placebo-controlled phase II study will compare the safety of a primary, intramuscular vaccination with Alum adjuvant and one or up to 3 booster injections without Alum adjuvant of DR4/1-Peptide at 6 and 8 week intervals in patients with rheumatoid arthritis. The ability of the DR4/1 peptide Vaccine to induce humoral antibody to the peptide and to a common recall antigen will be assessed and compared in patients who receive injections at 6 and 8 week intervals. A secondary objective is to evaluate potential changes in HLA-DR expression as a result of vaccinations and assess clinical activity of the vaccine. We are currently analyzing in vitro antibody and antigen data from our patients and continue this focus.