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.

抽象的： 在美国，性传播感染的发生率正在上升，包括 Neisseria Gonorrhoeae。淋病猪笼草中的抗生素耐药性也在增加，并被认为是 WHO和美国疾病预防控制中心严重新兴的公共卫生威胁。针对N.淋病的疫苗可以帮助 战斗抗生素耐药杆菌的传播，但是，淋病的有效疫苗具有 到目前为止，发现了发现。感染淋病猪笼草的个体不会产生随后的免疫力 感染，限制了我们对保护免受感染所需的免疫反应的理解。大量的 新西兰和其他国家的疫苗接种运动，采用疫苗针对N. meningitis serogroup B 由外膜囊泡制成的，随后降低了淋病链球菌的速率 这些国家的感染。美国FDA批准的N.脑膜炎血清群B疫苗（4C-MENB）包含 脑膜炎链球菌外膜囊泡和两种重组抗原都与N。 抗原的淋病同源物。我们的研究团队目前使用独特的人类实验 在其天然宿主中研究淋病链球菌的感染模型。因为尚未使用4C-MENB疫苗 在美国范围内，有一个独特且具有时间敏感的机会来测试其有效性 使用我们的人类挑战模型预防淋病猪笼草的疫苗。拟议的临床试验也将 允许我们研究对4C-MENB疫苗的免疫反应，并确定哪些反应对 疫苗的保护作用。当前的提案要求支持实施 拟议的临床试验，代表了有效的淋病开发的重要步骤 疫苗。