SQFETY/IMMUNOGENICITY OF INTRMUSCULAR VACCINATION WITH ALUM ADJUVANT IN RA

这项前瞻性、随机、安慰剂对照研究将比较 使用明矾佐剂进行初次肌内接种的安全性， 1次或最多3次加强注射，不含DR4/1-肽的明矾佐剂 在类风湿性关节炎患者中间隔6和8周。 的 DR4/1肽疫苗诱导抗DR4/1肽的体液抗体的能力 肽和常见的回忆抗原将被评估和比较， 每隔6周和8周接受注射的患者。 次级 目的是评估HLA-DR表达的潜在变化， 接种疫苗的结果。 另一个次要目标是评估 疫苗的临床活性。

This prospective, randomized placebo-controlled 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. Another secondary objective is to assess clinical activity of the vaccine.