VAGINAL IMMUNIZATION AGAINST URINARY TRACT INFECTIONS

复发性细菌性尿路感染(RUTI)是最常见的 妇女常见传染病和发病原因。一个 目前抗生素治疗和预防的替代方案是 使用疫苗对这种疾病进行免疫。一种可注射疫苗 因为Ruti已经在国外开发和销售，但由于 严重的不良的系统性影响。当时这种疫苗是 由Protein Express的新型阴道栓剂系统提供， 它的耐受性很好，导致尿路感染显著延迟。 复发。目前的临床研究试图进一步证明 该疫苗作为一种安全有效的粘膜免疫方法的应用 免疫接种。在继续这些研究的努力中，蛋白质 Express已经获得了这部电影的独家制作权 疫苗。我们现在寻求满足扩展这些和未来的需求 临床研究，满足GMP要求以允许FDA接受 用于生产，并提供该疫苗的稳定性数据。明确的 然后，可以设计Il阶段研究以满足商业目标 耐受性好、成本效益高的药物用于临床控制 鲁蒂。 建议的商业应用： 潜在的问题是反复的尿路感染，这是一种严重的 医疗问题，如最近NIH计划公告(PA)所示 97-073，“粘膜免疫在人类疾病的发病/预防中的作用”)。 这里描述的疫苗栓剂应该很快就能在 每年帮助约700万受肠道疾病影响的妇女 尿路感染。进一步的发展也可能在以下方面显示出实用性 预防其他泌尿生殖系统感染。

Recurrent bacterial urinary tract infections (rUTI) are among the most common infectious diseases and cause of morbidity in women. An alternative to the current antibiotic treatment and prophylaxis is the use of vaccines to immunize against this disease. An injectable vaccine for rUTI has been developed and marketed abroad but was withdrawn because of significant undesirable systemic effects. When this vaccine was administered by Protein Express' novel intravaginal suppository system, it was very well tolerated and resulted in a significant delay in UTI recurrence. Current clinical investigations seek to further demonstrate utility of this vaccine as a safe and effective method of mucosal immunization. In efforts to continue these investigations, Protein Express has acquired the exclusive rights for the production of this vaccine. We now seek to meet the needs of extending these and future clinical studies, meet GMP requirements essential to allow FDA acceptance for production, and provide stability data for this vaccine. Definitive Phase Il studies can then be designed to meet the commercial goal of a well-tolerated, cost-effective medication for the clinical control of rUTI. PROPOSED COMMERCIAL APPLICATIONS: The underlying problem, recurrent urinary tract infection, is a serious medical concern, as indicated in a recent NIH Program Announcement (PA 97-073, "Mucosal immunity in pathogenesis/prevention of human disease"). The vaccine suppository described herein should be quickly useful in helping the estimated 7 million women annually affected by enteric urinary tract infection. Further development may also show utility in protecting against other genitourinary infections.