London School of Hygiene & Tropical Medicine, Keppel Street, London, UK; College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Department of Pediatric, University of Texas Health Science Center McGovern Medical School, Houston, TX, USA.
Vaccine. 2019 Aug 14;37(35):4877-4885. doi: 10.1016/j.vaccine.2019.07.012. Epub 2019 Jul 11.
Group B Streptococcus (GBS) is an important cause of disease in young infants, stillbirths, pregnant and post-partum women. GBS vaccines for maternal immunization are in development aiming to reduce this burden. Standardisation of case definitions and ascertainment methodologies for GBS disease is needed to support future trials of maternal GBS vaccines. Considerations presented here may also serve to promote consistency in observational studies and surveillance, to better establish disease burden. The World Health Organization convened a working group to provide consensus guidance for case ascertainment and case definitions of GBS disease in stillbirths, infants, pregnant and post-partum women, with feedback sought from external stakeholders. In intervention studies, case capture and case ascertainment for GBS disease should be based on antenatal recruitment of women, with active follow-up, systematic clinical assessment, standardised sampling strategies and optimised laboratory methods. Confirmed cases of invasive GBS disease in stillbirths or infants should be included in a primary composite endpoint for vaccine efficacy studies, with GBS cultured from a usually sterile body site (may be post-mortem). For additional endpoints, or observational studies, confirmed cases of GBS sepsis in pregnant and post-partum women should be assessed. Culture independent diagnostic tests (CIDTs) may detect additional presumed cases, however, the use of these diagnostics needs further evaluation. Efficacy of vaccination against maternal and neonatal GBS colonisation, and maternal GBS urinary tract infection could be included as additional, separate, endpoints and/or in observational studies. Whilst the focus here is on specific GBS disease outcomes, intervention studies also present an opportunity to establish the contribution of GBS across adverse perinatal outcomes, including all-cause stillbirth, preterm birth and neonatal encephalopathy.
B 群链球菌（GBS）是导致婴幼儿、死胎、孕妇和产后妇女发病的重要原因。目前正在开发用于母体免疫的 GBS 疫苗，旨在减轻这一负担。为了支持未来的母体 GBS 疫苗试验，需要对 GBS 疾病的病例定义和确定方法进行标准化。这里提出的考虑因素也可能有助于促进观察性研究和监测的一致性，以便更好地确定疾病负担。世界卫生组织召集了一个工作组，为死胎、婴儿、孕妇和产后妇女的 GBS 疾病病例确定和病例定义提供共识指导，并征求了外部利益攸关方的反馈意见。在干预研究中，GBS 疾病的病例捕获和病例确定应基于对孕妇的产前招募，并进行积极的随访、系统的临床评估、标准化的采样策略和优化的实验室方法。应将死胎或婴儿中侵袭性 GBS 疾病的确诊病例纳入疫苗有效性研究的主要复合终点，从通常无菌的身体部位（可能是死后）培养出 GBS。对于其他终点或观察性研究，应评估孕妇和产后妇女中确诊的 GBS 败血症病例。非培养性诊断检测（CIDTs）可能会检测到更多疑似病例，但这些诊断检测的使用需要进一步评估。针对母体和新生儿 GBS 定植以及母体 GBS 尿路感染的疫苗效力可以作为额外的、独立的终点纳入研究，也可以在观察性研究中进行评估。虽然这里的重点是特定的 GBS 疾病结果，但干预研究也为确定 GBS 在包括所有原因死胎、早产和新生儿脑病在内的不良围产期结局中的作用提供了机会。
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