Infectious Diseases Division, Department of Medicine, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York.
Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
J Infect Dis. 2024 Oct 16;230(4):e905-e916. doi: 10.1093/infdis/jiae185.
Respiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well tolerated and immunogenic in a phase 1/2 study. We evaluated antibody persistence after initial vaccination and safety and immunogenicity after revaccination from this study.
Healthy adults were randomized to receive initial vaccination and revaccination 12 months later with either placebo or RSVpreF (240 µg with or without aluminum hydroxide). RSV-A and RSV-B geometric mean neutralizing titers (GMTs) were measured through 12 months after both vaccinations. Tolerability and safety were assessed.
There were 263 participants revaccinated (18-49 years old, n = 134; 65-85 years old, n = 129). Among 18- to 49-year-olds and 65- to 85-year-olds, geometric mean fold rises (GMFRs) for both RSV subgroups (RSV-A, RSV-B) 1 month after initial RSVpreF vaccination were 13.3 to 20.4 and 8.9 to 15.5, respectively, as compared with levels before initial vaccination; corresponding GMFRs 12 months after initial vaccination were 4.1 to 5.0 and 2.6 to 4.1. GMFRs 1 month after revaccination vs levels before revaccination were 1.4 to 2.3 and 1.4 to 2.2 for 18- to 49-year-olds and 65- to 85-year-olds. Peak GMTs after revaccination were lower than those after initial vaccination. GMTs 12 months after initial vaccination and revaccination were similar, with GMFRs ranging from 0.7 to 1.6. No safety signals occurred.
RSVpreF revaccination was immunogenic and well tolerated among adults. Clinical Trials Registration. NCT03529773 (ClinicalTrials.gov).
呼吸道合胞病毒（RSV）可引起严重的呼吸道疾病。二价 RSV 预融合 F（RSVpreF）疫苗已在≥60 岁人群中获批使用。在一项 1/2 期研究中，RSVpreF 具有良好的耐受性和免疫原性。我们评估了该研究中初始接种后的抗体持久性以及再次接种后的安全性和免疫原性。
健康成年人随机接受初始接种，并在 12 个月后用安慰剂或 RSVpreF（240μg 加或不加氢氧化铝）进行再次接种。接种后 12 个月内，通过测量 RSV-A 和 RSV-B 几何平均中和滴度（GMT）来评估 RSVpreF 接种的免疫原性。评估了耐受性和安全性。
263 名参与者接受了再次接种（18-49 岁，n=134；65-85 岁，n=129）。在 18-49 岁和 65-85 岁的参与者中，初始 RSVpreF 接种后 1 个月，两种 RSV 亚组（RSV-A，RSV-B）的几何平均倍数升高（GMFR）分别为 13.3 至 20.4 和 8.9 至 15.5，与初始接种前相比；初始接种后 12 个月的相应 GMFR 分别为 4.1 至 5.0 和 2.6 至 4.1。与再次接种前相比，再次接种后 1 个月的 GMFR 分别为 1.4 至 2.3 和 1.4 至 2.2，在 18-49 岁和 65-85 岁的参与者中。再次接种后的峰值 GMT 低于初始接种后的 GMT。初始接种和再次接种后 12 个月的 GMT 相似，GMFR 范围为 0.7 至 1.6。未出现安全性信号。
在成年人中，RSVpreF 再次接种具有免疫原性且耐受性良好。临床试验注册。NCT03529773（ClinicalTrials.gov）。
