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II期研究将 比较明矾初次肌内接种的安全性 佐剂和一次或最多3次无明矾佐剂的加强注射， 类风湿性关节炎患者中6周和8周间隔的DR 4/1-肽 关节炎DR 4/1肽疫苗诱导体液免疫的能力 将评估针对肽和针对共同回忆抗原的抗体 并在第6周和第8周接受注射的患者中进行比较 的间隔次要目的是评估以下方面的潜在变化 HLA-DR表达作为疫苗接种的结果，并评估临床 疫苗的活性。 我们目前正在分析来自我们的体外抗体和抗原数据。 患者，继续关注。

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.