呼吸道合胞病毒疫苗及其抗体制剂的研究进展

Research progress of respiratory syncytial virus vaccine and antibody preparations

呼吸道合胞病毒(respiratory syncytial virus,RSV)感染是一个全球性的健康问题,目前临床上仍缺乏特异的治疗手段。接种疫苗主动免疫预防或使用抗体制剂被动免疫预防是避免重症感染和减少死亡的重要措施。针对不同的人群,须研制不同类型的RSV疫苗:减毒活疫苗对婴儿来说,可能是最佳选择;亚单位疫苗有引起增强型呼吸道疾病的风险,不适合RSV血清学阴性的婴幼儿接种,主要适用于老年人和孕妇。研发安全且有效的RSV疫苗难度大,虽然已有30余种RSV疫苗进入临床研究阶段,并显示出应用潜力,其中F纳米颗粒疫苗已率先进入III期临床试验,但在老年人和孕妇中未达预期效果。在RSV流行季节前,使用特异性抗体制剂也是预防高危人群严重RSV感染性疾病的有效手段。长效单克隆抗体MEDI8897比帕利珠单抗更具成本效益,已进入III期临床试验,且获得优先研发资格。多克隆免疫球蛋白RI-002已在免疫缺陷人群中显示出较好的预防效果,具有进一步研发的现实意义。本综述针对近年来RSV疫苗及其抗体的研究进展进行阐述,期望为RSV的预防提供参考。

Respiratory syncytial virus(RSV)infection is an important global health problem.There is lack of specific treatment methods in clinical practice.Active prevention by vaccination or passive prevention by using antibody preparations are important measures to avoid severe infections and reduce deaths.Different RSV vaccines need to be developed for different populations.There are four main types of RSV vaccines under development.Live attenuated vaccines may be most suitable for infants.Subunit vaccines have the risk of causing enhanced respiratory diseases and are not suitable for infants with negative RSV serum vaccination,but they are mainly suitable for the elderly and pregnant women.Ensuring safety and immunogenicity is an important issue that needs to be solved in the development of RSV vaccines.Although there are many challenges in the development of RSV vaccines,more than 30 RSV vaccines have entered the clinical research stage,showing potential for application.Among them,the F nanoparticle vaccine has taken the lead in entering phase III clinical trials,but it has not achieved the expected effect in the elderly and pregnant women.Before the RSV epidemic season,using specific antibody is also an effective means to prevent severe infection in high-risk groups.The long-acting monoclonal antibody MEDI8897,which is more cost-effective than palivizumab,has entered phase III clinical trials,and has got priority R&D qualification.Polyclonal immunoglobulin RI-002 has shown good preventive effects in immunodeficiency populations,and has practical significance for further research.