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呼吸道合胞病毒（Respiratory syncytial virus,RSV）感染是引起婴幼儿和老年人下呼吸道疾病的重要原因，在全球范围内造成沉重的疾病负担。疫苗接种是控制RSV传播和减轻相关疾病负担的关键策略。全球目前已有三种基于RSV融合前构象F蛋白（Pre-fusion, Pre-F）研发的RSV疫苗获批上市，可为不同人群提供安全有效的主动免疫保护。本文从有效性、安全性和免疫原性三个方面对已上市的RSV疫苗进行综述，并对疫苗的长期保护效力、安全性评价和适用人群范围扩展等方面进行讨论，旨在为下一步RSV疫苗研究和应用提供参考。
Abstract：Respiratory syncytial virus(RSV) is a leading cause of lower respiratory tract infections in infants andolder adults, contributing to a substantial global disease burden. Vaccination represents a critical strategy forcontrolling RSV transmission and reducing the associated morbidity and mortality. To date, three RSV vaccinesbased on the pre-fusion conformation of the RSV F protein(Pre-F) have been approved for use, providing safeand effective active immunization across different population groups. This review summarizes the clinical data onthe efficacy, safety, and immunogenicity of these licensed vaccines. It also discusses current challenges andfuture directions, including long-term protective efficacy, ongoing safety monitoring, and the potentialexpansion of vaccination to broader target populations, with the aim of informing future RSV vaccine researchand implementation.
[1] Zhang XL, Zhang X, Hua W, et al. Expert consensus on the diagnosis, treatment, and prevention of respiratory syncytial virus infections in children[J].World J Pediatr, 2024, 20(1):11-25. DOI:10. 1007/s12519-023-00777-9.
[2] Du Y, Yan R, Wu X, et al. Global burden and trends of respiratory syncytial virus infection across different age groups from 1990 to 2019:a systematic analysis of the Global Burden of Disease 2019 Study[J]. Int J Infect Dis, 2023, 135:70-76. DOI:10. 1016/j.ijid. 2023. 08. 008.
[3] Li Y, Wang X, Blau DM, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019:a systematic analysis[J]. Lancet, 2022, 399(10340):2047-2064.DOI:10. 1016/S0140-6736(22)00478-0.
[4]范如艳.儿童呼吸道合胞病毒分子流行病学及其致炎症反应机制研究[D].衡阳：南华大学，2016.
[5] Lee N, Lui GY, Wong KT, et al. High morbidity and mortality in adults hospitalized for respiratory syncytial virus infections[J]. Clin Infect Dis, 2013, 57(8):1069-1077. DOI:10. 1093/cid/cit471.
[6] Topalidou X, Kalergis AM, Papazisis G. Respiratory syncytial virus vaccines:a review of the candidates and the approved vaccines[J]. Pathogens, 2023, 12(10):1259. DOI:10. 3390/pathogens12101259.
[7] Amarasinghe GK, Ayllón MA, Bào Y, et al.Taxonomy of the order mononegavirales:update 2019[J]. Arch Virol, 2019, 164(7):1967-1980. DOI:10. 1007/s00705-019-04247-4.
[8]崔代迅，杨小慧，冯振卿.呼吸道合胞病毒疫苗及中和抗体研究进展[J].南京医科大学学报（自然科学版），2024, 44(12):1763-1772.
[9] Killikelly AM, Kanekiyo M, Graham BS. Pre-fusion F is absent on the surface of formalin-inactivated respiratory syncytial virus[J]. Sci Rep, 2016, 6:34108. DOI:10. 1038/srep34108.
[10]McLellan JS, Chen M, Gordon Joyce M, et al.Structure-based design of a fusion glycoprotein vaccine for respiratory syncytial virus[J]. Science, 2013, 342(6158):592-598. DOI:10. 1126/science. 1243283.
[11]Britton A, Roper LE, Kotton CN, et al. Use of respiratory syncytial virus vaccines in adults aged≥60years:updated recommendations of the advisory committee on immunization practices-United States,2024[J]. MMWR Morb Mortal Wkly Rep, 2024, 73(32):696-702. DOI:10. 15585/mmwr. mm7332e1.
[12]Fleming-Dutra KE, Jones JM, Roper LE, et al. Use of the pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in infants:recommendations of the advisory committee on immunization practices-United States, 2023[J].MMWR Morb Mortal Wkly Rep, 2023, 72(41):1115-1122. DOI:10. 15585/mmwr. mm7241e1.
[13]Papi A, Ison MG, Langley JM, et al. Respiratory syncytial virus prefusion F protein vaccine in older adults[J]. N Engl J Med, 2023, 388(7):595-608. DOI:10. 1056/NEJMoa2209604.
[14]Walsh EE, Marc GP, Zareba AM, et al. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults[J]. N Engl J Med, 2023, 388(16):1465-1477.DOI:10. 1056/NEJMoa2213836.
[15]Wilson E, Goswami J, Baqui AH, et al. Efficacy and safety of an mRNA-based RSV PreF vaccine in older adults[J]. N Engl J Med, 2023, 389(24):2233-2244.DOI:10. 1056/NEJMoa2307079.
[16]Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants[J]. N Engl J Med, 2023, 388(16):1451-1464. DOI:10. 1056/NEJMoa2216480.
[17]Feldman RG, Antonelli-Incalzi R, Steenackers K, et al. Respiratory syncytial virus prefusion F protein vaccine is efficacious in older adults with underlying medical conditions[J]. Clin Infect Dis, 2024, 78(1):202-209. DOI:10. 1093/cid/ciad471.
[18]Obando-Pacheco P, Justicia-Grande AJ, Rivero-Calle I, et al. Respiratory syncytial virus seasonality:a global overview[J]. J Infect Dis, 2018, 217(9):1356-1364.DOI:10. 1093/infdis/jiy056.
[19]谢智博，段晓健，郭晋源，等. 2017—2020年河南省漯河市呼吸道合胞病毒流行特征研究[J].病毒学报，2021, 37(3):554-560. DOI:10. 13242/j. cnki.bingduxuebao. 003972.
[20]Ison MG, Papi A, Athan E, et al. Efficacy and safety of respiratory syncytial virus(RSV)prefusion F protein vaccine(RSVPreF3 OA)in older adults over 2 RSV seasons[J]. Clin Infect Dis, 2024, 78(6):1732-1744.DOI:10. 1093/cid/ciae010.
[21]GSK. GSK presents positive data for arexvy, its respiratory syncytial virus(RSV)vaccine, indicating protection over three RSV seasons[EB/OL].(2024-10-8)[2024-10-13]. https：//www. gsk. com/en-gb/media/press-releases/gsk-presents-positive-data-forarexvy-its-rsv-vaccine-indicating-protection-over-threersv-seasons/.
[22]Pfizer. Pfizer announces positive top-line data for full season two efficacy of ABRYSVO?for RSV in older adults[EB/OL].(2024-4-9)[2024-8-23]. https：//www. pfizer. com/news/press-release/press-releasedetail/pfizer-announces-positive-top-line-results-phase-3-study-1.
[23]ACIP. Update on moderna’s RSV vaccine, mresvia(mrna-1345), in adults≥60 years of age[EB/OL].(2024-6-26)[2024-10-5]. https：//stacks. cdc. gov/view/cdc/157864.
[24]Lloyd P. Evaluation of guillain-barre syndrome(GBS)following RSV vaccination among adults 65 years and older[EB/OL].[2024-9-7]. https：//www. cdc. gov/acip/downloads/slides-2024-06-26-28/06-RSV-AdultLloyd-508. pdf.
[25]Pfizer. ABRYSVO package insert.[EB/OL].(2023)[2024-8-17]. https：//www. fda. gov/media/168889/download.
[26]Son M, Riley LE, Staniczenko AP, et al.Nonadjuvanted bivalent respiratory syncytial virus vaccination and perinatal outcomes[J]. JAMA Netw Open, 2024, 7(7):e2419268. DOI:10. 1001/jamanetworkopen. 2024. 19268.
[27]Dieussaert I, Hyung Kim J, Luik S, et al. RSV prefusion F protein-based maternal vaccine-preterm birth and other outcomes[J]. N Engl J Med, 2024, 390(11):1009-1021. DOI:10. 1056/NEJMoa2305478.
[28]Kim HW, Canchola JG, Brandt CD, et al. Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine[J]. Am J Epidemiol, 1969, 89(4):422-434. DOI:10. 1093/oxfordjournals. aje. a120955.
[29]Acosta PL, Caballero MT, Polack FP. Brief history and characterization of enhanced respiratory syncytial virus disease[J]. Clin Vaccine Immunol, 2015, 23(3):189-195. DOI:10. 1128/CVI. 00609-15.
[30]Snape M D, Moore J, Du J, et al. Safety and immunogenicity of an mrna-based rsv vaccine and an rsv/hmpv combination vaccine in children 5 to 23 months of age[Z]. Preprints. 2024. 10. 20944/preprints202412. 0878. v1
[31]FDA. Considerations for respiratory syncytial virus(RSV)vaccine safetyin pediatric populations[EB/OL].(2024-12-12)[2024-12-12]. https：//www. fda.gov/media/184301/download.
[32]Schwarz TF, Hwang SJ, Ylisastigui P, et al.Immunogenicity and safety following 1 dose of AS01Eadjuvanted respiratory syncytial virus prefusion F protein vaccine in older adults:a phase 3 trial[J]. J Infect Dis,2024, 230(1):e102-e110. DOI:10. 1093/infdis/jiad546.
[33]Gurtman A. Bivalent RSV prefusion f vaccine in adults≥60 years of age[EB/OL].(2023-2-28)[2024-12-13]. https：//www. fda. gov/media/165737/download.
[34]Shaw CA, Essink B, Harper C, et al. Safety and immunogenicity of an mRNA-based RSV vaccine including a 12-month booster in a phase 1 clinical trial in healthy older adults[J]. J Infect Dis, 2024, 230(3):e647-e656. DOI:10. 1093/infdis/jiae081.
[35]Shaw CA, Mithani R, Kapoor A, et al. Safety,tolerability, and immunogenicity of an mRNA-based respiratory syncytial virus vaccine in healthy young adults in a phase 1 clinical trial[J]. J Infect Dis, 2024,230(3):e637-e646. DOI:10. 1093/infdis/jiae035.
[36]Walsh EE, Falsey AR, Scott DA, et al. A randomized phase 1/2 study of a respiratory syncytial virus prefusion F vaccine[J]. J Infect Dis, 2022, 225(8):1357-1366.DOI:10. 1093/infdis/jiab612.
[37]Sim?es EAF, Center KJ, Tita ATN, et al. Prefusion F protein-based respiratory syncytial virus immunization in pregnancy[J]. N Engl J Med, 2022, 386(17):1615-1626. DOI:10. 1056/NEJMoa2106062.
[38]Baber J, Arya M, Moodley Y, et al. A phase 1/2 study of a respiratory syncytial virus prefusion F vaccine with and without adjuvant in healthy older adults[J]. J Infect Dis, 2022, 226(12):2054-2063. DOI:10. 1093/infdis/jiac189.
[39]Who. Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines[EB/OL].(2020-11-11)[2025-02-20]. https：//www. who. int/publications/m/item/respiratory-syncytial-virus-vaccines-annex-2-trs-no-1024.
[40]虞结梅，郑妍鹏，彭向雷，等.人呼吸道合胞病毒疫苗研发的突破及挑战[J].中国食品药品监管，2023(12):64-73.
基本信息:
DOI：10.13242/j.cnki.bingduxuebao.240327
中图分类号:R186
引用信息:
[1]蓝林晨,刘晓辉,卢姣汐,等.上市呼吸道合胞病毒疫苗临床研究进展[J].病毒学报,2025,41(03):915-922.DOI:10.13242/j.cnki.bingduxuebao.240327.
基金信息:
中央高校基本科研业务费专项资金资助（项目号：20720220006）,题目：全链条快速疫苗与分子诊断应急响应技术体系建设~~
2025-04-25
2025-04-25
2025-04-25