Hospital Moinhos de Vento, Responsabilidade Social, Porto Alegre, RS, Brazil; Pontifícia Universidade Católica do Rio Grande do Sul, Escola de Medicina, Porto Alegre, RS, Brazil.
Hospital Moinhos de Vento, Responsabilidade Social, Porto Alegre, RS, Brazil; Pontifícia Universidade Católica do Rio Grande do Sul, Escola de Medicina, Porto Alegre, RS, Brazil.
J Pediatr (Rio J). 2023 Mar-Apr;99 Suppl 1(Suppl 1):S4-S11. doi: 10.1016/j.jped.2022.10.004. Epub 2022 Nov 17.
Despite the global impact of the Respiratory Syncytial Virus (RSV) infection in children, only one monoclonal antibody (Palivizumab) has been approved for clinical use. However, advances in the knowledge of RSV immunology may enable the development of safe and effective new vaccines and monoclonal antibodies in a few years. The purpose of this review is to summarize available data on approved and developing passive and active immunizations against RSV in childhood and pregnancy.
A non-systematic review of RSV immunoprophylaxis in childhood and pregnancy was carried out in PubMed, path.org and clinical trial registries, without language restrictions, up to September 2022.
Three monoclonal antibodies and 17 active immunization candidates are under development in phase 1 to 3 clinical studies. Regarding the first group, Nirsevimab is a monoclonal antibody with a prolonged half-life whose approval for clinical use is expected in the next months. Among the vaccines under development, six techniques are being used: protein subunit, viral particles, live attenuated virus, recombinant viral vector, chimeric, and mRNA. The first two approaches are being tested primarily in pregnancy, while the others are being developed for the pediatric population.
The approval of extended half-life monoclonal antibodies is the next expected advance in RSV prevention, although the costs may be a barrier to the implementation. Regarding active immunizations, maternal and infant vaccination are complementary strategies and there are many promising candidates in clinical studies using different platforms.
尽管呼吸道合胞病毒 (RSV) 感染在全球范围内对儿童产生了影响,但目前仅有一种单克隆抗体(帕利珠单抗)被批准用于临床应用。然而,随着 RSV 免疫学知识的进步,在未来几年内,可能会开发出安全有效的新型疫苗和单克隆抗体。本文的目的是总结目前已批准和正在开发的针对儿童和妊娠期间 RSV 的被动和主动免疫接种的数据。
在 PubMed、path.org 和临床试验注册中心,对儿童和妊娠期间 RSV 免疫预防进行了非系统性综述,检索时间截至 2022 年 9 月,不限制语言。
目前有 3 种单克隆抗体和 17 种主动免疫候选物正在进行 1 期至 3 期临床试验。关于第一个单克隆抗体,尼昔单抗是一种半衰期较长的单克隆抗体,预计在未来几个月内将获得临床应用批准。在正在开发的疫苗中,使用了 6 种技术:蛋白亚单位、病毒颗粒、减毒活病毒、重组病毒载体、嵌合和 mRNA。前两种方法主要在妊娠期间进行测试,而其他方法则针对儿童人群进行开发。
延长半衰期的单克隆抗体的批准是 RSV 预防的下一个预期进展,尽管成本可能是实施的障碍。关于主动免疫接种,母亲和婴儿的疫苗接种是互补的策略,在使用不同平台的临床试验中有许多有前途的候选物。