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

4C-MenB 免疫预防实验性尿道淋病奈瑟菌感染的功效。

• 批准号: 10435532
• 负责人: JOSEPH A DUNCAN
• 金额: $ 78.07万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10435532
• 关键词: Address; Antibiotic Resistance; Antibiotic Therapy; Antibiotics; Antibodies; Antigens; Antimicrobial Resistance; Atopobium vaginae; Bacteria; Biological; Case-Control Studies; Centers for Disease Control and Prevention (U.S.); Chlamydia trachomatis; Clinical Trials; Country; Cuba; Data; Development; Diphtheria; Disease; Drug-resistant Neisseria Gonorrhoeae; Exhibits; Exposure to; FDA approved; Future; Goals; Gonorrhea; Human; Immune; Immune Evasion; Immune response; Immunity; Immunization; Immunize; Immunoglobulin A; Immunoglobulin G; Immunoglobulin M; Immunologics; Incidence; Individual; Infection; Infection prevention; Influenza A virus; Knowledge; Mass Vaccinations; Membrane; Meningococcal vaccine; Modeling; Monoclonal Antibodies; Mus; Natural Immunity; Neisseria gonorrhoeae; Neisseria meningitidis; New Zealand; Norway; Observational Study; Outcome; Participant; Pathogenesis; Prevention; Public Health; Randomized Controlled Trials; Recombinants; Regulatory T-Lymphocyte; Reporting; Request for Proposals; Research; Research Design; Resistance; Risk; Schedule; Serogroup B Neisseria meningitidis; Serum; Sexual Transmission; Sexually Transmitted Diseases; Specimen; Testing; Tetanus; Time; United States; Upper respiratory tract; Urethra; Urethritis; Vaccination; Vaccines; Vesicle; Work; antibiotic resistant infections; antimicrobial; arm; bactericide; base; combat; cross immunity; effectiveness testing; efficacy testing; epidemiologic data; flu; gonorrhea vaccine; high risk population; human male; influenza virus vaccine; men; pathogen; pathogenic bacteria; pre-clinical; prevent; protective effect; randomized trial; response; stem; trial comparing; unvaccinated; vaccine development; vaccine effectiveness; vaccine platform; vaginal infection; young adult; young man

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.

摘要： 在美国，性传播感染的比率正在上升，包括由 淋病奈瑟菌。淋球菌对抗生素的耐药性也在增加，已被认为是一种 世卫组织和美国疾控中心新出现的严重公共卫生威胁。一种针对淋病奈瑟菌的疫苗可能会有所帮助 然而，对抗抗药性淋球菌的传播，一种有效的淋病疫苗已经 到目前为止，还没有发现。感染淋病奈瑟菌的人不会对随后的 感染，限制了我们对保护免受感染所需的免疫反应的了解。质量 在新西兰和其他国家开展B群脑膜炎奈瑟氏菌疫苗接种活动 由外膜囊泡制成的淋病奈瑟菌报告发病率降低。 这些国家的感染情况。美国FDA批准的B群脑膜炎奈瑟氏菌疫苗(4C-MenB)包含 脑膜炎奈瑟氏菌外膜囊泡和与脑膜炎奈瑟氏菌高度相关的两种重组抗原。 淋病病毒抗原的同源物。我们的研究团队目前使用了一种独特的人体实验 淋病自然宿主感染模型的研究。因为4C-MANB疫苗的使用还没有开始 在美国普遍存在，有一个独特的和时间敏感的机会来测试这一方法的有效性 我们的人类挑战模型在预防淋病疫苗中的应用。拟议的临床试验还将 使我们能够研究对4C-MenB疫苗的免疫反应，并确定哪些反应是必要的 疫苗的保护作用。目前的提案要求支持执行 拟议的临床试验，这是开发有效的淋球菌的重要一步 疫苗。