RSV是一种高度流行的、传染性很强的呼吸道病毒，是导致支气管炎和肺炎的主要原因，每年在世界范围内影响超过6400万人。幼儿、老年人和那些有潜在健康状况的人是风险最高的。每年，RSV导致5岁以下儿童超过300万人住院、近6万人死亡。在老年人中，仅在美国，RSV每年导致17.7万人住院，1.4万人死亡【1】。中国需RSV预防人数近4亿，高风险老年患病人数约500万。
目前，全球范围内还未有获批上市的RSV疫苗产品，我国的RSV治疗也仅限于缓解疾病症状【2】。GSK和辉瑞是RSV预防领域跑得最快的两家公司，各有一款老年人预防用的RSV疫苗即将在今年5月获批FDA批准上市，并且辉瑞的RSV疫苗同样适用于婴儿（母体主动免疫），而Novavax、Pierre fabre、Moderna多家公司也进入到Ⅲ期临床实验。在国内，RSV赛道仅艾棣维欣（ADV110，II期）和优锐医药（MVA-BN RSV，Ⅲ期）布局疫苗产品，华南疫苗、博沃生物、沃森生物/蓝鹊生物、石药集团等处于临床前阶段，而爱科百发、泰诺麦博等公司则专注于开发RSV治疗性药物。
RSV是一种包膜病毒，编码11种蛋白质，包括2种非结构蛋白（NS1和NS2）；4种膜蛋白：粘附糖蛋白 (G)，融合蛋白(F)，基质蛋白 (M) 和小疏水蛋白（SH）；以及五种核糖核酸酶蛋白：核蛋白（N）、磷蛋白（P）、大RNA聚合酶（L）、M2-1（一种锌结合转录反终止子）和M2-2（一种参与RNA复制和转录平衡的调节因子）【3】。
图1 RSV结构【3】
粘附G蛋白主要负责对宿主细胞的附着，能使RSV吸附于宿主细胞上导致感染开始。融合蛋白F，被宿主蛋白酶切割成F1（48K）和F2（26K）两个片段后才具有活性，能引起病毒囊膜与宿主细胞膜融合，有利于病毒穿入细胞。G和F蛋白是产生中和抗体最重要的抗原表位，也是诱导机体产生免疫原性和抗病毒的最主要靶点，F蛋白的抗体较G蛋白的抗体中和作用强【3】。
F蛋白在RSV毒株中高度保守，使其成为一个很好的潜在疫苗靶点。F蛋白以三聚体形式存在，有两种构象，融合前Pre-F和融合后Post-F，融合前不如融合后的构象稳定但更具免疫原性【3】。两种构象在结构上有很大不同，有着不同的抗原表位。目前在Pre-F中已鉴定出7种抗原表位(Ⅰ、Ⅱ、Ⅲ、Ⅳ、Ⅴ、Ø和Quaternary -Dependent)，以及可以和不同表位结合的抗体【4,5】。
表Pre-F抗原表位及结合抗体【4,5】
| Pre-F抗原表位 | 抗体 |
| 表位Ⅰ | 131-2a, 2F |
| 表位Ⅱ | Motavizumab/palivizumab |
| 表位Ⅲ | MPE8 |
| 表位Ⅳ | 101F/mAb19 |
| 表位Ⅴ | hRSV90 |
| 表位Ø | D25/5C4/AM22 |
| Quaternary-Dependent | AM14 |
RSV相关重组蛋白、抗体等试剂在诊断试剂开发、疫苗和药物开发中应用广泛。近岸蛋白推出高质量的重组G蛋白和Pre-F蛋白，以及重组G和Pre-F抗体，可用于抗原和抗体诊断试剂的开发，疫苗和药物开发的临床前研究、临床研究及质量控制环节等。
| 货号 | 产品名称 |
| DRA230 | Recombinant RSV Prefusion F-trimer Protein (strain A2) |
| DRA231 | Recombinant RSV G Protein (strain A2) |
| DA091 | RSV F Antibody (11A9) |
| DA092 | RSV G Antibody (2G7) |
DRA230抗原与多种抗体结合活性ELISA验证数据
| 抗体 | Motavizumab | MPE8 | 11.92 ng/mL | AM14 | DA091 |
| ED50值 | 4.9 ng/mL | 11.92 ng/mL | 4.28 ng/mL | 4.29ng/mL | 4.37ng/mL |
经ELISA验证，RSV Pre-F与文献报道的Motavizumab、MPE8、D25、AM14，以及近岸蛋白DA091抗体均有结合活性。
DA091
Immobilized RSV F Antibody (11A9)(Cat#DA091) at 2μg/ml (100μl/well ) can bind Recombinant RSV Prefusion F-trimer Protein (strain A2)(Cat#DRA230) .The ED50 of Recombinant RSV Prefusion F-trimer Protein (strain A2)(Cat#DRA230) is 4.37 ng/ml. (Regularly tested)
AM14
Immobilized RSV F antibody (AM14) at 2μg/ml (100 μl/well) can bind Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230). The ED50 of Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230) is 4.29 ng/ml. (Regularly tested)
D25
Immobilized RSV F antibody (D25) at 2μg/ml (100 μl/well) can bind Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230). The ED50 of Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230) is 4.28 ng/ml. (Regularly tested)
MPE8
Immobilized RSV F antibody (MPE8) at 2μg/ml (100 μl/well) can bind Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230). The ED50 of Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230) is 11.92 ng/ml. (Regularly tested)
Motavizumab
Immobilized RSV F antibody (Motavizumab) at 2μg/ml (100 μl/well) can bind Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230). The ED50 of Recombinant RSV Prefusion F-trimer Protein (strain A2) (Cat#DRA230) is 4.9 ng/ml. (Regularly tested)
DRA230抗原经WB验证数据
Western blot - RSV F Antibody (11A9)(Cat#DA091)
FACS Analysis of RSV-preF full length LNP-mRNA Expression
5e5 of 293T cells transfected with RSV-preF full length LNP-mRNA were incubated with 100 μL of 10 μg/mL of RSV F Antibody (11A9) (Cat. No.: DA091) prior to staining with APC-conjugated anti Human IgG (Fig.C) and negative isotype control antibody (Fig.B), and non-transfected 293T cells were used as a control (Fig.A), binding activity was analyzed with APC signal (Regularly tested).
参考文献：
1. https://www.jnj.com/janssen-announces-u-s-fda-breakthrough-therapy-designation-for-investigational-prophylactic-vaccine-for-the-prevention-of-respiratory-syncytial-virus-in-older-adults
2. 动脉网，RSV疫苗中国III期临床获批，呼吸特药精耕又一里程碑！
3. Drysdale SB, Barr RS, Rollier CS, Green CA, Pollard AJ, Sande CJ. Priorities for developing respiratory syncytial virus vaccines in different target populations. Sci Transl Med. 2020 Mar 18;12(535):eaax2466. doi: 10.1126/scitranslmed.aax2466. PMID: 32188721; PMCID: PMC7613568.
4. Gilman MS, Moin SM, Mas V, Chen M, Patel NK, Kramer K, Zhu Q, Kabeche SC, Kumar A, Palomo C, Beaumont T, Baxa U, Ulbrandt ND, Melero JA, Graham BS, McLellan JS. Characterization of a Prefusion-Specific Antibody That Recognizes a Quaternary, Cleavage-Dependent Epitope on the RSV Fusion Glycoprotein. PLoS Pathog. 2015 Jul 10;11(7):e1005035. doi: 10.1371/journal.ppat.1005035. PMID: 26161532; PMCID: PMC4498696.
5. McLellan JS, Chen M, Leung S, Graepel KW, Du X, Yang Y, Zhou T, Baxa U, Yasuda E, Beaumont T, Kumar A, Modjarrad K, Zheng Z, Zhao M, Xia N, Kwong PD, Graham BS. Structure of RSV fusion glycoprotein trimer bound to a prefusion-specific neutralizing antibody. Science. 2013 May 31;340(6136):1113-7. doi: 10.1126/science.1234914. Epub 2013 Apr 25. PMID: 23618766; PMCID: PMC4459498.