National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30329-4027, USA; Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30329-4027, USA.
Vaccine. 2019 Nov 28;37(50):7307-7314. doi: 10.1016/j.vaccine.2016.12.029. Epub 2016 Dec 22.
Globally, group B Streptococcus (GBS) remains a leading cause of sepsis and meningitis in infants in the first 90days of life. Intrapartum antibiotic prophylaxis (IAP) for women at increased risk of transmitting GBS to their newborns has been effective in reducing part, but not all, of the GBS disease burden in many high income countries (HICs). In low- and middle-income countries (LMICs), IAP use is low. Immunization of pregnant women with a GBS vaccine represents an alternative strategy to protecting newborns and young infants, through transplacental antibody transfer and potentially by reducing new vaginal colonization. This vaccination strategy was first suggested in the 1970s and several potential GBS vaccines have completed phase I/II clinical trials. During the 2015 WHO Product Development for Vaccines Advisory Committee meeting, GBS was identified as a high priority for the development of a vaccine for maternal immunization because of the major public health burden posed by GBS in LMICs, and the high technical feasibility for successful development. Following this meeting, the first WHO technical consultation on GBS vaccines was held on the 27th and 28th of April 2016, to consider development pathways for such vaccines, focused on their potential role in reducing newborn and young infant deaths and possibly stillbirths in LMICs. Discussion topics included: (1) pathophysiology of disease; (2) current gaps in the knowledge of global disease burden and serotype distribution; (3) vaccine candidates under development; (4) design considerations for phase III trials; and (5) pathways to licensure, policy recommendations and use. Efforts to address gaps identified in each of these areas are needed to establish the public health need for, the development and deployment of, efficacious GBS vaccines. In particular, more work is required to understand the global disease burden of GBS-associated stillbirths, and to develop quality-assured standardized antibody assays to identify correlates of protection.
全球范围内，B 型链球菌（GBS）仍然是导致婴儿生命最初 90 天内败血症和脑膜炎的主要原因。对有传播 GBS 风险的孕妇进行分娩时抗生素预防（IAP），在许多高收入国家（HIC）有效降低了部分但不是全部 GBS 疾病负担。在中低收入国家（LMIC），IAP 的使用很低。用 GBS 疫苗对孕妇进行免疫接种是保护新生儿和婴儿的另一种策略，通过胎盘抗体转移，并可能通过减少新的阴道定植来实现。这种疫苗接种策略最早在 20 世纪 70 年代提出，几种潜在的 GBS 疫苗已完成 I/II 期临床试验。在 2015 年世界卫生组织疫苗产品开发咨询委员会会议期间，GBS 被确定为开发用于孕妇免疫的疫苗的高度优先事项，因为 GBS 在 LMIC 造成的重大公共卫生负担，以及成功开发的高技术可行性。此次会议之后，于 2016 年 4 月 27 日和 28 日举行了首次世界卫生组织关于 GBS 疫苗的技术磋商，以审议此类疫苗的开发途径，重点是它们在减少 LMIC 中新生儿和婴儿死亡以及可能的死产方面的潜在作用。讨论的主题包括：（1）疾病的发病机制；（2）目前对全球疾病负担和血清型分布的认识差距；（3）正在开发的疫苗候选物；（4）III 期试验的设计考虑因素；以及（5）许可途径、政策建议和用途。需要努力解决这些领域中发现的差距，以确定针对 GBS 疫苗的公共卫生需求、开发和部署。特别是，需要开展更多工作，以了解 GBS 相关死产的全球疾病负担，并开发质量保证的标准化抗体检测，以确定保护相关性。
