Efficacy of immunization with 4C-MenB in preventing experimental urethral infection with Neisseria gonorrhoeae.

摘要： 在美国，性传播感染的比率正在上升，其中包括由性传播感染引起的感染 淋病奈瑟菌。淋病奈瑟菌的抗生素耐药性也在增加，并已被认为是一种 世界卫生组织和美国疾病预防控制中心正在对新出现的严重公共卫生威胁进行评估。针对淋病奈瑟菌的疫苗可能会有所帮助 对抗抗生素耐药性淋病奈瑟菌的传播，然而，一种有效的淋病奈瑟菌疫苗已经出现 迄今为止尚未被发现。感染淋病奈瑟菌的个体不会对随后的感染产生免疫力 感染，限制了我们对防止感染所需的免疫反应的理解。弥撒 新西兰和其他国家开展针对 B 群脑膜炎奈瑟氏球菌疫苗的疫苗接种活动 由外膜囊泡制成的药物导致淋病奈瑟菌的发病率降低 这些国家的感染情况。美国 FDA 批准的 B 血清群脑膜炎奈瑟菌疫苗 (4C-MenB) 含有 脑膜炎奈瑟氏球菌外膜囊泡和与脑膜炎奈瑟氏球菌高度相关的两种重组抗原。 淋病抗原的同系物。我们的研究团队目前使用独特的人体实验 研究自然宿主中淋病奈瑟菌的感染模型。因为4C-MenB疫苗还没有使用 在美国广泛存在，有一个独特且时间敏感的机会来测试这一方法的有效性 使用我们的人类挑战模型预防淋病奈瑟菌的疫苗。拟议的临床试验还将 让我们能够研究对 4C-MenB 疫苗的免疫反应，并确定哪些反应对于 疫苗的保护作用。当前提案请求支持实施 拟议的临床试验，这是开发有效的淋病奈瑟菌的重要一步 疫苗。

Abstract: Rates of sexually transmitted infections are on the rise in the United States, including those caused by Neisseria gonorrhoeae. Antibiotic resistance in N. gonorrhoeae is also increasing and has been recognized as a serious emerging public health threat by WHO and the US CDC. A vaccine against N. gonorrhoeae could help combat the spread of antibiotic resistant N. gonorrhoeae, however, an effective vaccine for N. gonorrhoeae has thus far eluded discovery. Individuals infected with N. gonorrhoeae do not develop immunity to subsequent infection, limiting our understanding of the immune responses required for protection from infection. Mass vaccination campaigns in New Zealand and other countries with vaccines against N. meningitidis serogroup B made from outer membrane vesicles have been followed by reduced reported rates of N. gonorrhoeae infections in those countries. The US FDA-approved N. meningitidis serogroup B vaccine (4C-MenB) contains both N. meningitidis outer membrane vesicles and two recombinant antigens that are highly related to N. gonorrhoeae homologs of the antigens. Our research team currently uses a unique human experimental infection model to study N. gonorrhoeae in its natural host. Because the use of the 4C-MenB vaccine is not yet widespread within the US, there is a unique and time-sensitive opportunity to test the effectiveness of this vaccine in preventing N. gonorrhoeae using our human challenge model. The proposed clinical trial will also allow us to study immune responses to the 4C-MenB vaccine and determine which responses are essential to the protective effect of the vaccine. The current proposal requests support for the implementation of the proposed clinical trial, which represents an important step in the development of an effective N. gonorrhoeae vaccines.