Vaccine Research Unit, Fisabio, Public Health, Avenida Cataluña 21, 46020 Valencia, Spain; CIBERESP, Instituto de Salud Carlos III, Madrid, Spain.
Statistics and Operational Research Department, University of Valencia, Calle del Dr. Moliner 50, 46100 Burjassot, Valencia, Spain.
J Infect Public Health. 2024 Aug;17(8):102492. doi: 10.1016/j.jiph.2024.102492. Epub 2024 Jul 8.
A new monoclonal antibody (nirsevimab; Beyfortus®) and a bivalent prefusion RSV vaccine (Abrysvo®) for maternal immunization have been approved recently. This is a modelling study to estimate the potential impact of different immunization programs with these products on RSV-bronchiolitis.
Population-based real-world data from primary care and hospitalizations were considered. RSV bronchiolitis dynamics in absence of these immunization scenarios were explained by a multivariate age-structured Bayesian model. Then, the potential impact was simulated under different assumptions including the most recent clinical trial data. Differences in endpoints, populations, and timeframes between trials make the two products' efficacy difficult to compare.
A seasonal with catch-up program, assuming a constant effectiveness of 79.5 % during the first 5 months followed by a linear decay to 0 by month 10 with nirsevimab, would prevent between 5121 and 8846 RSV bronchiolitis per 100,000 infants-years. Assuming 77.3 % effectiveness with the same decay, between 976 and 1686 RSV-hospitalizations per 100,000 infants-years could be prevented depending on the uptake. A year-round maternal immunization program, with 51 % of effectiveness during the first 6 months followed by a linear decay to 0 by month 10 would prevent between 3246 and 5606 RSV bronchiolitis cases per 100,000 infants-years. Assuming 56.9 % effectiveness with the same decay, between 713 and 1231 RSV-hospitalizations per 100,000 infants-years could be prevented.
Our results suggest that each strategy would effectively reduce RSV-bronchiolitis.
最近，一种新的单克隆抗体（尼昔单抗；Beyfortus®）和一种二价 RSV 融合前疫苗（Abrysvo®）已被批准用于母体免疫接种。这是一项建模研究，旨在评估使用这些产品进行不同免疫接种计划对 RSV 细支气管炎的潜在影响。
考虑了初级保健和住院的基于人群的真实世界数据。通过多变量年龄结构贝叶斯模型解释了在没有这些免疫接种方案的情况下 RSV 细支气管炎的动态。然后，根据最近的临床试验数据，模拟了不同假设下的潜在影响。由于试验之间的终点、人群和时间框架存在差异，因此很难比较两种产品的疗效。
假设使用尼昔单抗进行季节性追赶免疫接种计划，在头 5 个月内有效性保持常数为 79.5%，然后到第 10 个月线性下降至 0，那么每 100,000 婴儿年可预防 5121 至 8846 例 RSV 细支气管炎。如果采用相同的衰减假设，77.3%的有效性，每 100,000 婴儿年可预防 976 至 1686 例 RSV 住院。如果进行全年母体免疫接种计划，在头 6 个月内有效性为 51%，然后到第 10 个月线性下降至 0，那么每 100,000 婴儿年可预防 3246 至 5606 例 RSV 细支气管炎。如果采用相同的衰减假设，56.9%的有效性，每 100,000 婴儿年可预防 713 至 1231 例 RSV 住院。
我们的研究结果表明，每种策略都将有效地减少 RSV 细支气管炎。
