Therapy and Prophylaxis for Genital Tract Infection

描述（由申请方提供）：淋病奈瑟菌（淋病）的生殖道感染不会诱导特异性保护性免疫状态，并且可以反复获得。尽管采取了公共卫生措施，但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继续出现。新的研究结果表明，N.淋病通过引发它可以存活的先天性反应和通过抑制将消除它的特异性适应性反应来破坏免疫系统，以使其自身受益。该SBIR申请寻求开发一种新的策略，该策略利用TherapyX，Inc.，用于阴道内施用以有效地重定向针对N.淋病将在阴道淋球菌感染的小鼠模型中评价本品，该模型已被接受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，该产品可以诱导抗淋球菌T细胞和抗体反应，以对抗现有的感染，并加速其清除，此外，可以召回，以引起对再次感染的保护。回忆效应的持续时间，以及对不同菌株的保护能力。淋病，将被确定。第一阶段的成功完成将导致第二阶段，其中产品剂量将被优化，毒性将被测试，并对自然发生的N.淋病和长期疗效将进行评估，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.