Meningococcal B Vaccine to Prevent Neisseria gonorrhoeae Infection.

Observational studies suggest that the four-component meningococcal serogroup B vaccine (4CMenB) may reduce the risk of gonorrhea.

观察性研究表明，四价脑膜炎球菌B群疫苗（4CMenB）可能降低淋病的风险。

Methods

In this multicenter, double-blind, randomized, placebo-controlledtrial, we assigned, in a 1:1 ratio, men who have sex with men (MSM) to receive two doses of 4CMenB or placebo.

在这项多中心、双盲、随机、安慰剂对照试验中，我们按1:1的比例分配了男男性行为者（MSM），让他们接受两剂4CMenB或安慰剂。

All the participants had recently received a diagnosis of N. gonorrhoeae infection or infectious syphilis and either tested negative for human immunodeficiency virus (HIV) and were receiving HIV preexposure prophylaxis or were living with HIV.

所有参与者最近都被诊断出患有淋病或传染性梅毒，并且要么对人类免疫缺陷病毒（HIV）检测呈阴性并正在接受HIV暴露前预防，要么正在与HIV共存。

Screening for sexually transmitted infections, including N. gonorrhoeae nucleic acid amplification testing of samples obtained from urogenital, anorectal, and oropharyngeal sites, was performed quarterly for 2 years.

对包括从泌尿生殖器、肛门和口咽部位获得的样本进行的性传播感染筛查，包括N.淋病奈瑟菌核酸扩增检测，每季度进行一次，持续2年。

The primary outcome was a first N. gonorrhoeae infection after the receipt of vaccine or placebo in the per-protocol population (participants who received both 4CMenB or placebo doses, attended at least two scheduled follow-up visits after the second dose, and did not meet any exclusion criterion pertinent to the assessment of efficacy).

主要结果是在接种疫苗或安慰剂后，在符合方案人群（即接受了全部4CMenB或安慰剂剂量、在第二次接种后至少参加了两次预定随访访问且未达到任何与评估有效性相关的排除标准的参与者）中首次出现N.淋病奈瑟菌感染。

Results

From July 2021 through May 2023, a total of 654 participants underwent randomization, of whom 587 were included in the primary analysis.

从2021年7月到2023年5月，共有654名参与者进行了随机分组，其中587名被纳入主要分析。

The incidenceof N. gonorrhoeae infection was 48.1 events per 100 person-years (160 events among 296 participants) in the 4CMenB group and 47.8 events per 100 person-years (155 events among 291 participants) in the placebo group (incidencerate ratio, 1.01; 95% confidence interval[CI], 0.80 to 1.26; P = 0.97), for a vaccine efficacy of -0.5% (95% CI, -26.2 to 19.9).

在4CMenB组中，淋球菌感染的发生率为每100人年48.1次事件（296名参与者中有160次事件），而在安慰剂组中为每100人年47.8次事件（291名参与者中有155次事件）（发生率比，1.01；95%置信区间[CI]，0.80至1.26；P = 0.97），疫苗的有效性为-0.5%（95% CI，-26.2至19.9）。

Vaccine efficacy was 5.5% (95% CI, -56.0 to 42.8) for symptomatic infection, -6.4% (95% CI, -47.5 to 23.2) for asymptomatic infection, and -20.0% (95% CI, -90.2 to 23.9), -1.2% (95% CI, -33.0 to 23.0), and 2.6% (95% CI, -27.7 to 25.7) for urogenital, anorectal, and oropharyngeal infection, respectively.

疫苗对有症状感染的效力为5.5%（95%置信区间，-56.0至42.8），对无症状感染的效力为-6.4%（95%置信区间，-47.5至23.2），对泌尿生殖道、肛门直肠和口咽感染的效力分别为-20.0%（95%置信区间，-90.2至23.9）、-1.2%（95%置信区间，-33.0至23.0）和2.6%（95%置信区间，-27.7至25.7）。

Serious adverse events occurred in 4.7% of the participants in the 4CMenB group and in 2.8% of those in the placebo group.

在4CMenB组中，4.7%的参与者发生了严重不良事件，而在安慰剂组中，这一比例为2.8%。

Conclusions

4CMenB did not result in a lower incidenceof N. gonorrhoeae infection than placebo among MSM who were at high risk for gonorrhea.

4CMenB疫苗在高危淋病感染的MSM人群中，并没有比安慰剂更能降低N. gonorrhoeae感染的发生率。

(Funded by the Australian National Health and Medical Research Council and GSK; GoGoVax ClinicalTrials.gov number, NCT04415424.).

(该研究由澳大利亚国家卫生与医学研究委员会和GSK资助；GoGoVax临床试验注册号为NCT04415424。)