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。

基本信息

批准号：
10263478
负责人：
JOSEPH A DUNCAN
金额：
$ 80.95万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
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/10263478
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 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 vaccine development vaccine effectiveness vaginal infection young adult young man

项目摘要

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。大量的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。