Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, North Adelaide, South Australia, Australia.
Robinson Research Institute and Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.
BMJ Open. 2019 May 6;9(5):e027233. doi: 10.1136/bmjopen-2018-027233.
Invasive meningococcal disease is uncommon but associated with a high-case fatality rate. Carriage prevalence of the causative bacteria, , is high in adolescents. A large (n=34 500) cluster randomised controlled trial (RCT) to assess the impact of a meningococcal B (MenB) vaccine on meningococcal carriage was implemented in the state of South Australia (SA) for year 10, 11 and 12 senior school students in 2017-2018. This study will assess the impact of MenB vaccine (4CMenB) on carriage prevalence in school leavers in SA, 1 and 2 years after implementation of the cluster RCT in adolescents. Measuring the impact of population programmes on carriage can assist in informing future meningococcal immunisation programmes such as targeted age groups and use of catch-up campaigns.
This repeat cross-sectional study will assess carriage prevalence in 2018 and 2019. All school leavers who attended year 12 in any school in SA in 2018 or 2019 will be invited to participate in this study. An oropharyngeal swab will be taken from each participating student and a risk factor questionnaire completed by the student following informed consent. Students will attend clinics at SA universities, technical colleges, and metropolitan, rural and remote government council clinics. Confirmed vaccination history will allow a comparison in carriage prevalence between vaccinated and unvaccinated school leavers. A sample size of 4096 students per year will provide 80% power to detect a 20% difference in carriage prevalence of disease-causing meningococci (defined as genogroup A, B, C, W, X or Y) between years.
The study was approved by the Women's and Children's Health Network Human Research Ethics Committee. Results will be published in international peer review journals and presented at national and international conferences.
NCT03419533; Pre-results.
侵袭性脑膜炎球菌病并不常见，但病死率很高。引起这种疾病的细菌 的携带率在青少年中很高。2017-2018 年，在南澳大利亚州（SA）针对 10 至 12 年级的高中生实施了一项大规模（n=34500）的群组随机对照试验（RCT），以评估脑膜炎球菌 B 型（MenB）疫苗对脑膜炎球菌携带的影响。本研究将评估 MenB 疫苗（4CMenB）对 SA 离校生携带率的影响，即在青少年群组 RCT 实施 1 至 2 年后。衡量人群计划对携带率的影响有助于为未来的脑膜炎球菌免疫计划提供信息，例如针对特定年龄组和使用追赶运动。
本重复横断面研究将评估 2018 年和 2019 年的携带率。邀请 2018 年或 2019 年在南澳大利亚州任何学校就读 12 年级的所有离校生参加这项研究。将从每个参与的学生中采集咽拭子，并在获得知情同意后由学生完成风险因素问卷。学生将参加南澳大利亚大学、技术学院以及大都市、农村和偏远地区政府理事会诊所的诊所。已确认的疫苗接种史将允许比较接种和未接种疫苗的离校生之间的携带率差异。每年 4096 名学生的样本量将提供 80%的效力，以检测导致疾病的脑膜炎球菌（定义为 A、B、C、W、X 或 Y 基因型）的携带率在两年间差异 20%。
该研究得到了妇女和儿童健康网络人类研究伦理委员会的批准。结果将发表在国际同行评议期刊上，并在国家和国际会议上展示。
NCT03419533；预结果。
