Schepp Rutger M, Kaczorowska Joanna, van Gageldonk Pieter G M, Rouers Elsbeth D M, Sanders Elisabeth A M, Bruijning-Verhagen Patricia C J, Berbers Guy A M
Centre for Infectious Disease Control, National Institute for Public Health and the Environment, P.O. Box 1, 3720 BA Bilthoven, The Netherlands.
Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, 3508 GA Utrecht, The Netherlands.
Vaccines (Basel). 2023 Dec 2;11(12):1807. doi: 10.3390/vaccines11121807.
Respiratory Syncytial Virus (RSV) poses a severe threat to infants, particularly preterm infants. Palivizumab, the standard preventive prophylaxis, is primarily utilized in high-risk newborns due to its cost. This study assessed palivizumab's effectiveness in preventing RSV infections in predominantly very preterm infants during their first year of life. Serum samples from a prospective multicentre cohort study in the Netherlands were analyzed to assess RSV infection rates by measuring IgG levels against three RSV proteins: nucleoprotein, pre-fusion, and post-fusion protein. Infants were stratified based on gestational age (GA), distinguishing very preterm (≤32 weeks GA) from moderate/late preterm (>32 to ≤36 weeks GA). In very preterm infants, palivizumab prophylaxis significantly reduced infection rates (18.9% vs. 48.3% in the prophylaxis vs. non-prophylaxis group. Accounting for GA, sex, birth season, and birth weight, the prophylaxis group showed significantly lower infection odds. In infants with >32 to ≤36 weeks GA, the non-prophylaxis group (55.4%) showed infection rates similar to the non-prophylaxis ≤32-week GA group, despite higher maternal antibody levels in the moderate/late preterm infants. In conclusion, palivizumab prophylaxis significantly reduces RSV infection rates in very premature infants. Future research should explore clinical implications and reasons for non-compliance, and compare palivizumab with emerging prophylactics like nirsevimab aiming to optimize RSV prophylaxis and improve preterm infant outcomes.
呼吸道合胞病毒（RSV）对婴儿，尤其是早产儿构成严重威胁。帕利珠单抗作为标准的预防性药物，因其成本因素主要用于高危新生儿。本研究评估了帕利珠单抗在预防主要为极早产儿出生后第一年RSV感染方面的有效性。对荷兰一项前瞻性多中心队列研究的血清样本进行分析，通过测量针对三种RSV蛋白（核蛋白、融合前蛋白和融合后蛋白）的IgG水平来评估RSV感染率。婴儿根据胎龄（GA）进行分层，区分极早产儿（GA≤32周）和中度/晚期早产儿（>32至≤36周GA）。在极早产儿中，帕利珠单抗预防显著降低了感染率（预防组为18.9%，非预防组为48.3%）。综合考虑GA、性别、出生季节和出生体重，预防组的感染几率显著较低。在GA>32至≤36周的婴儿中，非预防组（55.4%）的感染率与GA≤32周的非预防组相似，尽管中度/晚期早产儿的母体抗体水平较高。总之，帕利珠单抗预防可显著降低极早产儿的RSV感染率。未来的研究应探讨临床意义和不依从性原因，并将帕利珠单抗与新型预防性药物如尼塞韦单抗进行比较，旨在优化RSV预防并改善早产儿结局。
