St George's University of London, London, SW17 0RE, UK.
UK Health Security Agency, London, UK.
F1000Res. 2024 May 21;13:519. doi: 10.12688/f1000research.147555.1. eCollection 2024.
Group B streptococcus (GBS) remains a leading cause of infant sepsis, meningitis and death despite intrapartum antibiotic prophylaxis. A vaccine is urgently required, and two candidates are in advanced clinical trials. For successful GBS vaccine implementation, especially if a vaccine is licensed based on an immunological threshold, there must be cross-sector engagement, effective advocacy, robust plans for phase IV studies and equitable access.
A round-table discussion, held at St George's University of London, reviewed the current position of GBS vaccines in the UK context, focusing on phase IV plans, convening a diverse group of stakeholders from across the UK, with a role in GBS vaccine licensure, advocacy, implementation or effectiveness evaluation.Presentations outlined the latest UK epidemiology, noting the rising infant invasive GBS (iGBS) infection rates from 1996 to 2021 for both early and late onset disease, with the highest disease rates in Black infants (1.1/1000 livebirths vs white infants (0.81/1000 livebirths). Potential coverage of the candidate vaccines was high (>95%). Regulatory input suggested that EU regulators would consider waiving the need for a pre-licensure efficacy study if a putative correlate of protection could be adequately justified. Phase IV study methodologies for a GBS vaccine were considered, largely based on previous UK maternal vaccine assessments, such as a nationwide cohort study design using a vaccine register and a maternal services dataset. Other strategies were also discussed such as a cluster or stepped-wedge randomised trial to evaluate implementation outcomes. Opportunities for advocacy, education and engagement with additional key partners were discussed and identified.
With an approved GBS vaccine a near possibility, planning of phase IV studies and identification of critical barriers to implementation are urgently needed. Cross-sector engagement is essential and will facilitate a successful pathway.
尽管有分娩时抗生素预防措施，B 组链球菌（GBS）仍然是导致婴儿败血症、脑膜炎和死亡的主要原因。迫切需要一种疫苗，目前有两种候选疫苗正在进行临床试验。为了成功实施 GBS 疫苗，特别是如果疫苗是基于免疫阈值获得许可的，就必须跨部门参与、进行有效的宣传、制定强有力的第四阶段研究计划以及实现公平准入。
在伦敦圣乔治大学举行的一次圆桌讨论会上，审查了 GBS 疫苗在英国的当前情况，重点讨论了第四阶段计划，召集了来自英国各地的利益相关者，他们在 GBS 疫苗许可、宣传、实施或有效性评估方面发挥作用。演讲者介绍了英国最新的流行病学情况，指出从 1996 年到 2021 年，早发性和晚发性疾病的婴儿侵袭性 GBS（iGBS）感染率都在上升，黑人婴儿的疾病率最高（每 1000 例活产中有 1.1 例），而白人婴儿的疾病率为 0.81/1000 例活产。候选疫苗的潜在覆盖率很高（>95%）。监管部门表示，如果可以充分证明保护的相关因素，欧盟监管机构将考虑免除疫苗上市前疗效研究的必要性。考虑了 GBS 疫苗的第四阶段研究方法，主要基于英国以前的母体疫苗评估，例如使用疫苗登记处和产妇服务数据集的全国性队列研究设计。还讨论了其他策略，例如评估实施结果的聚类或阶跃式随机试验。讨论并确定了宣传、教育和与其他关键合作伙伴接触的机会。
由于批准 GBS 疫苗的可能性很大，因此迫切需要规划第四阶段研究并确定实施的关键障碍。跨部门参与是必不可少的，这将为成功的途径提供便利。
