VAGINAL IMMUNIZATION AGAINST URINARY TRACT INFECTIONS

预防尿路感染的阴道免疫接种

• 批准号: 2645267
• 负责人: MICHAEL L HOWELL
• 金额: $ 9.88万
• 依托单位: PROTEIN EXPRESS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-08-01 至 1999-05-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2645267
• 关键词: active immunization; bacterial vaccines; biotechnology; dosage forms; drug administration routes; drug quality /standard; laboratory mouse; mucosal immunity; relapse /recurrence; urinary tract infection; vaccine development; vagina

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 An injectable vaccine for rUTI has been developed and marketed abroad but was withdrawn because of significant undesirable systemic effects.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.

复发性细菌性尿路感染（鲁蒂）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 使用疫苗来免疫这种疾病。注射疫苗 鲁蒂已在国外开发和上市，但因 严重的不良全身反应。当这种疫苗 通过Protein Express的新型阴道内栓剂系统给药， 它的耐受性非常好，并导致UTI的显著延迟 复发目前的临床研究试图进一步证明 该疫苗作为粘膜免疫的安全有效方法的效用 次免疫 为了继续这些研究，Protein 快递公司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大这些和未来的需要， 临床研究，符合GMP要求，这是FDA接受的必要条件 并提供该疫苗的稳定性数据。明确 然后可以设计II期研究以满足商业目标， 耐受性良好、成本效益高的药物，用于临床控制 鲁蒂。 拟议的商业应用： 潜在的问题，复发性尿路感染，是一个严重的 医疗问题，如最近的NIH计划公告（PA）所示 97-073，“Mucobacterium immunity in pathogenesis/prevention of human disease”）。 本文所述的疫苗栓剂应可快速用于 每年帮助大约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显示出实用性， 预防其他泌尿生殖系统感染。