Therapy and Prophylaxis for Genital Tract Infection

描述(申请人提供)：生殖道感染淋球菌(淋病)不会诱导特定的保护性免疫状态，可以反复获得。尽管采取了公共卫生措施，这种疾病仍然以令人无法接受的高频率持续存在；没有针对它的疫苗，甚至对最新一代抗生素的耐药性也在继续出现。新的发现表明，淋病奈瑟菌为了自身的利益而颠覆免疫系统，它通过激发它可以生存的天生反应，并通过抑制特定的适应性反应来消除它。这种SBIR应用寻求开发一种新的策略，利用治疗公司已经开发的一种专有产品在阴道内应用，有效地重定向免疫反应以对抗淋病奈瑟菌。该产品将在阴道淋球菌感染的小鼠模型上进行评估，该模型已被公认为目前唯一可用的动物模型。第一阶段的目的是建立原理证明，该产品可以诱导针对现有感染的抗淋球菌T细胞和抗体反应，并加速其清除，而且可以被召回，以获得对再次感染的保护。召回效力的持续时间，以及它对不同淋病奈瑟菌株的保护能力，将被确定。第一阶段的成功完成将导致第二阶段，在这一阶段中，产品剂量将得到优化，毒性将进行测试，并将评估对各种自然发生的淋病菌株的交叉保护和长期疗效，为临床试验做准备。

DESCRIPTION (provided by applicant): Genital tract infection with Neisseria gonorrhoeae (gonorrhea) does not induce a state of specific protective immunity and can be acquired repeatedly. Despite public health measures, the disease persists at an unacceptably high frequency; there is no vaccine against it, and resistance even to the latest generations of antibiotics continues to emerge. New findings reveal that N. gonorrhoeae subverts the immune system for its own benefit by eliciting innate responses that it can survive and by suppressing specific adaptive responses that would eliminate it. This SBIR application seeks to develop a novel strategy utilizing a proprietary product already developed by TherapyX, Inc., for intravaginal application to redirect the immune response effectively against N. gonorrhoeae. The product will be evaluated in a mouse model of vaginal gonococcal infection that has become accepted as the only currently available animal model. Phase I aims to establish proof-of- principle that the product can induce anti-gonococcal T-cell and antibody responses against the existing infection and accelerate its clearance, and moreover can be recalled to elicit protection against re-infection. The duration of the recall effect, and its ability to afford protection againt different strains of N. gonorrhoeae, will be determined. Successful completion of Phase I will lead to Phase II in which product dosage will be optimized, toxicity will be tested, and cross-protection against a diversity of naturally occurring strains of N. gonorrhoeae and long-term efficacy will be evaluated in preparation for clinical trial.