METHODS: This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies.
BACKGROUND: Ethical approval was obtained from the St Vincent\'s Hospital Human Research Ethics Committee, St Vincent\'s Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences.
BACKGROUND: NCT04415424.
方法:这是双盲,GBM+的随机安慰剂对照试验,暴露前预防HIV时HIV阴性或感染HIV(CD4计数>350细胞/mm3),在过去18个月内诊断为淋病或传染性梅毒(与淋病奈瑟菌感染高风险相关的关键特征)。参与者以1:1的比例随机分配,间隔3个月接受两剂4CMenB或安慰剂。参与者在24个月内有3个月的访问,其中包括淋病奈瑟菌和其他性传播感染的检测,人口统计数据的集合,性行为风险和抗生素使用,并收集研究样本以分析淋病奈瑟菌特异性全身和粘膜免疫反应。主要结果是第一次淋病奈瑟菌感染的发生率,通过核酸扩增试验确定,后4个月。其他结果考虑不同解剖部位有症状或无症状的淋病奈瑟菌感染的发生率(即,泌尿生殖系统,肛门直肠或口咽),淋病奈瑟菌基因型和抗菌素耐药表型的发病率,淋病奈瑟菌特异性抗体的水平和功能活性。
背景:从圣文森特医院人类研究伦理委员会获得伦理批准,圣文森特医院悉尼,新南威尔士州,澳大利亚(参考:2020/ETH01084)。结果将在同行评审的期刊上传播,并在国家和国际会议上发表。
背景:NCT04415424。