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: 10615898
• 负责人: JOSEPH A DUNCAN
• 金额: $ 77.96万
• 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/10615898
• 关键词: Address; Antibiotic Resistance; Antibiotic Therapy; Antibiotics; Antibodies; Antigens; Antimicrobial Resistance; Atopobium vaginae; Bacteria; Biological; Case/Control Studies; Chlamydia trachomatis; Clinical Trials; Country; Cuba; Data; Development; Diphtheria; Disease; Drug-resistant Neisseria Gonorrhoeae; Exhibits; Exposure to; FDA approved; Future; Goals; Gonorrhea; Homologous Gene; 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; Recommendation; 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; 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，性传播感染率正在上升，包括由以下原因引起的感染： 淋病奈瑟菌N.淋病也在增加，并已被认为是一种 世界卫生组织和美国疾病控制和预防中心正在对新出现的严重公共卫生威胁进行评估。针对N.淋病可以帮助 对抗耐抗生素N.淋病奈瑟氏球菌是一种有效的疫苗。淋病有 至今未被发现感染N.淋病不会产生免疫力， 感染，限制了我们对保护免受感染所需的免疫反应的理解。质量 在新西兰和其他国家开展疫苗接种运动，接种抗N. B群脑膜炎 由外膜囊泡制成，随后报道的N.淋病 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）含有 两个N。脑膜炎外膜囊泡和两个与脑膜炎外膜囊泡高度相关的重组抗原。 抗原的淋病同源物。我们的研究团队目前使用一种独特的人类实验 感染模型来研究N.淋病在其自然宿主。因为4C-MenB疫苗的使用还没有 在美国广泛传播，有一个独特的和时间敏感的机会来测试这种有效性， 疫苗预防N.淋病使用我们的人类挑战模型。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不可少的， 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，这是一个重要的一步，在发展一个有效的N。淋病 疫苗。