Department of General Practice and Primary Health Care, University of Auckland, Auckland, New Zealand.
Department of General Practice and Primary Health Care, University of Auckland, Auckland, New Zealand.
Lancet. 2017 Sep 30;390(10102):1603-1610. doi: 10.1016/S0140-6736(17)31449-6. Epub 2017 Jul 10.
Gonorrhoea is a major global public health problem that is exacerbated by drug resistance. Effective vaccine development has been unsuccessful, but surveillance data suggest that outer membrane vesicle meningococcal group B vaccines affect the incidence of gonorrhoea. We assessed vaccine effectiveness of the outer membrane vesicle meningococcal B vaccine (MeNZB) against gonorrhoea in young adults aged 15-30 years in New Zealand.
We did a retrospective case-control study of patients at sexual health clinics aged 15-30 years who were born between Jan 1, 1984, and Dec 31, 1998, eligible to receive MeNZB, and diagnosed with gonorrhoea or chlamydia, or both. Demographic data, sexual health clinic data, and National Immunisation Register data were linked via patients' unique personal identifier. For primary analysis, cases were confirmed by laboratory isolation or detection of Neisseria gonorrhoeae only from a clinical specimen, and controls were individuals with a positive chlamydia test only. We estimated odds ratios (ORs) comparing disease outcomes in vaccinated versus unvaccinated participants via multivariable logistic regression. Vaccine effectiveness was calculated as 100×(1-OR).
11 of 24 clinics nationally provided records. There were 14 730 cases and controls for analyses: 1241 incidences of gonorrhoea, 12 487 incidences of chlamydia, and 1002 incidences of co-infection. Vaccinated individuals were significantly less likely to be cases than controls (511 [41%] vs 6424 [51%]; adjusted OR 0·69 [95% CI 0·61-0·79]; p<0·0001). Estimate vaccine effectiveness of MeNZB against gonorrhoea after adjustment for ethnicity, deprivation, geographical area, and sex was 31% (95% CI 21-39).
Exposure to MeNZB was associated with reduced rates of gonorrhoea diagnosis, the first time a vaccine has shown any protection against gonorrhoea. These results provide a proof of principle that can inform prospective vaccine development not only for gonorrhoea but also for meningococcal vaccines.
GSK Vaccines.
淋病是一个严重的全球公共卫生问题,其耐药性问题日益严重。有效的疫苗开发尚未成功,但监测数据表明,脑膜炎奈瑟菌 B 型外膜囊泡疫苗对外膜囊泡脑膜炎奈瑟菌 B 型(MeNZB)的影响淋病发病率。我们评估了在新西兰 15-30 岁年轻人中使用脑膜炎奈瑟菌 B 型外膜囊泡疫苗(MeNZB)预防淋病的疫苗效力。
我们对性健康诊所 15-30 岁的患者进行了回顾性病例对照研究,这些患者于 1984 年 1 月 1 日至 1998 年 12 月 31 日出生,有资格接种 MeNZB,并被诊断为淋病或衣原体,或两者兼有。通过患者唯一的个人识别码将人口统计学数据、性健康诊所数据和国家免疫登记数据进行链接。在主要分析中,病例通过实验室分离或仅从临床标本中检测到淋病奈瑟菌来确诊,对照组是仅衣原体检测阳性的个体。我们通过多变量逻辑回归比较了疫苗接种者和未接种者的疾病结局,计算了比值比(OR)。疫苗效力的计算方法是 100×(1-OR)。
全国有 24 家诊所提供了记录。进行了 14730 例病例和对照分析:1241 例淋病发病率,12487 例衣原体发病率,1002 例合并感染发病率。接种疫苗的个体发生淋病的可能性明显低于对照组(511[41%]比 6424[51%];调整后的 OR 0.69[95%CI 0.61-0.79];p<0.0001)。调整种族、贫困、地理区域和性别后,MeNZB 预防淋病的疫苗效力估计为 31%(95%CI 21-39)。
接触 MeNZB 与淋病诊断率降低有关,这是疫苗首次显示出对淋病的任何保护作用。这些结果提供了一个原则性的证明,可以为淋病和脑膜炎球菌疫苗的前瞻性疫苗开发提供信息。
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