Department of Pediatrics, Cincinnati Children's Hospital, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Department of Pediatrics, University of Cincinnati College of Medicine, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Sci Adv. 2023 Oct 27;9(43):eadj7611. doi: 10.1126/sciadv.adj7611. Epub 2023 Oct 25.
Respiratory syncytial virus (RSV) can lead to serious disease in infants, and no approved RSV vaccine is available for infants. This first in-human clinical trial evaluated a single dose of BLB201, a PIV5-vectored RSV vaccine administrated via intranasal route, for safety and immunogenicity in RSV-seropositive healthy adults (33 to 75 years old). No severe adverse events (SAEs) were reported. Solicited local and systemic AEs were reported by <50% of participants and were mostly mild in intensity. Vaccine virus shedding was detected in 17% of participants. Nasal RSV-specific immunoglobulin A responses were detected in 48%, the highest level observed in adults among all intranasal RSV vaccines evaluated in humans. RSV-neutralizing antibodies titers in serum rose ≥1.5-fold. Peripheral blood RSV F-specific CD4 and CD8 T cells increased from ≤0.06% at baseline to ≥0.26 and 0.4% after vaccination, respectively, in >93% participants. The safety and immunogenicity profile of BLB201 in RSV-seropositive adults supports the further clinical development of BLB201.
呼吸道合胞病毒（RSV）可导致婴儿罹患严重疾病，但目前尚无针对婴儿的 RSV 疫苗获得批准。这是一项首次在人体中进行的临床试验，评估了 RSV 血清阳性健康成年人（33 至 75 岁）经鼻内途径接种一剂 BLB201（一种基于 PIV5 的 RSV 疫苗）的安全性和免疫原性。未报告严重不良事件（SAE）。<50%的参与者报告了有针对性的局部和全身不良事件（AE），且大多数为轻度。17%的参与者检测到疫苗病毒脱落。在所有已在人体中评估的经鼻内接种 RSV 疫苗中，鼻 RSV 特异性免疫球蛋白 A 应答在 48%的参与者中检测到，这是成年人中观察到的最高水平。血清中的 RSV 中和抗体滴度升高≥1.5 倍。外周血 RSV F 特异性 CD4 和 CD8 T 细胞分别从基线时的≤0.06%增加到接种后的≥0.26%和≥0.4%，在>93%的参与者中均如此。BLB201 在 RSV 血清阳性成年人中的安全性和免疫原性特征支持 BLB201 的进一步临床开发。
