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

这项前瞻性、随机、安慰剂对照的第二阶段研究将 比较一次肌肉接种疫苗和明矾疫苗的安全性 佐剂和一次或最多3次不含明矾佐剂的佐剂注射 类风湿患者间隔6周和8周的DR4/1-肽 关节炎。DR4/1多肽疫苗诱导体液免疫的能力 将对多肽和共同召回抗原的抗体进行评估 在6周和8周接受注射的患者中进行比较 间隔时间。第二个目标是评估潜在的变化 接种疫苗后人类白细胞抗原-DR的表达及临床评估 疫苗的活性。 我们目前正在分析我们的体外抗体和抗原数据 患者和继续关注这一点。

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.