PDF(Pubmed)
Abstract：
BACKGROUND: The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.
METHODS: This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4-7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.
BACKGROUND: The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.
METHODS: This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4-7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.
BACKGROUND: The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.
摘要：
背景：由于不断升级的抗生素耐药性，抗生素治疗淋球菌感染的有效性受到损害；有效淋球菌疫苗的开发一直具有挑战性。新的证据表明，许可的脑膜炎球菌B（MenB）疫苗，4CMenB对淋球菌感染有效，这是由于两种细菌之间的交叉反应抗体和95％的遗传同源性，脑膜炎奈瑟菌和淋病奈瑟菌,导致疾病。该项目旨在进行流行病学和基因组监测，以评估4CMenB疫苗在北领地（NT）和南澳大利亚（SA）的淋球菌感染的长期保护，并确定加强疫苗剂量的潜在益处，以提供针对淋球菌感染的长期保护。
方法：这项观察性研究将提供4CMenB计划实施后4-7年4CMenB疫苗对淋球菌感染的有效性的长期评估结果。常规应呈报疾病通知将是评估疫苗对淋球菌感染影响的基础。病理学实验室将提供有关淋病奈瑟菌阳性测试相对于所有测试的数量和百分比的数据，并将协调分离物的分子测序。基因组测序结果将由SA病理学和区域病理学/新南威尔士州健康病理学提供，并与SAHealth和NTHealth的通知数据相关联。观察性研究存在局限性，包括潜在的混杂因素。将针对每个结果/比较分别分析混杂因素。
背景：方案和所有研究文件已由SA健康与福祉部人类研究伦理委员会（HREC/2022/HRE00308）审查和批准，评估将在获得NT健康与孟席斯健康研究学院人类研究伦理委员会的批准后在NT开始。结果将在同行评审的期刊上发表，并在科学会议和公共论坛上发表。
方法：这项观察性研究将提供4CMenB计划实施后4-7年4CMenB疫苗对淋球菌感染的有效性的长期评估结果。常规应呈报疾病通知将是评估疫苗对淋球菌感染影响的基础。病理学实验室将提供有关淋病奈瑟菌阳性测试相对于所有测试的数量和百分比的数据，并将协调分离物的分子测序。基因组测序结果将由SA病理学和区域病理学/新南威尔士州健康病理学提供，并与SAHealth和NTHealth的通知数据相关联。观察性研究存在局限性，包括潜在的混杂因素。将针对每个结果/比较分别分析混杂因素。
背景：方案和所有研究文件已由SA健康与福祉部人类研究伦理委员会（HREC/2022/HRE00308）审查和批准，评估将在获得NT健康与孟席斯健康研究学院人类研究伦理委员会的批准后在NT开始。结果将在同行评审的期刊上发表，并在科学会议和公共论坛上发表。
