Paediatric Infectious Diseases Research Group and Vaccine Institute, St George's University of London and St George's University Hospitals National Health Service Trust, London, UK; Institute of Infection and Immunity, St George's University of London and St George's University Hospitals National Health Service Trust, London, UK.
The Vaccine Centre, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK.
Lancet Infect Dis. 2019 May;19(5):e162-e171. doi: 10.1016/S1473-3099(18)30659-5. Epub 2019 Jan 22.
Group B streptococcus (GBS) is a leading cause of young infant mortality and morbidity globally, with vaccines being developed for over four decades but none licensed to date. A serocorrelate of protection against invasive disease in young infants is being considered to facilitate vaccine early licensure, followed by demonstration of efficacy assessed postlicensure. In this Review, we synthesise the available scientific evidence to define an immune correlate associated with GBS disease risk reduction on the basis of studies of natural infection. We summarise studies that have investigated GBS serum anticapsular or anti-protein antibodies, and studies measuring the association between antibody function and disease risk reduction. We highlight how knowledge on the development of correlates of protection from existing vaccines could be harnessed to facilitate GBS vaccine development. These lessons include aggregation of serocorrelates of protection for individual serotypes, understanding the relationship between immunity derived from natural exposure of adults and vaccine-induced immunity, or using extrapolation of protection from in-vitro immunoassay results. We also highlight key considerations for the assessment of the role of antibodies to derive a serocorrelate of risk reduction in future seroepidemiological studies of GBS disease.
B 群链球菌(GBS)是全球导致婴幼儿死亡和发病的主要原因,尽管已开发该疫苗超过 40 年,但尚未获得许可。正在考虑针对侵袭性疾病的血清学保护相关性,以促进疫苗早期许可,然后在许可后评估功效。在这篇综述中,我们综合了现有科学证据,以根据自然感染研究来确定与 GBS 疾病风险降低相关的免疫相关性。我们总结了研究 GBS 血清荚膜或抗蛋白抗体的研究,以及研究抗体功能与疾病风险降低之间关系的研究。我们强调了如何利用现有疫苗的保护相关性知识来促进 GBS 疫苗的开发。这些经验教训包括聚合针对个体血清型的保护血清学相关性、了解成人自然暴露和疫苗诱导免疫产生的免疫之间的关系,或使用体外免疫测定结果的推断来保护。我们还强调了在未来 GBS 疾病血清流行病学研究中评估抗体作用以得出风险降低血清学相关性的关键考虑因素。