HVTN 123：一项1期随机试验，比较稳定和瞬时转染细胞系产生的CH505TF gp120的安全性和免疫原性。
HVTN 123: A Phase 1, Randomized Trial Comparing Safety and Immunogenicity of CH505TF gp120 Produced by Stably and Transiently Transfected Cell Lines.
作者信息
Wilson Gregory J, Church L W Preston, Kelley Colleen F, Robinson Samuel T, Lu Yiwen, Furch Briana D, Fong Youyi, Paez Carmen A, Yacovone Margaret, Jacobsen Thomas, Maughan Maureen, Martik Diana, Heptinstall Jack R, Zhang Lu, Montefiori David C, Tomaras Georgia D, Kublin James G, Corey Lawrence
机构信息
Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
出版信息
J Infect Dis. 2025 Apr 15;231(4):e764-e769. doi: 10.1093/infdis/jiae558.
Utilizing transiently transfected cell lines could significantly reduce manufacturing timelines for protein subunit vaccines. This trial compared safety and immunogenicity of human immunodeficiency virus (HIV) envelope CH505TF gp120 vaccines produced by upstream stable and transient transfection (each admixed with GLA-SE adjuvant, a TL4 agonist). Both vaccines were safe and well tolerated. Serum IgG binding antibody response rates 2 weeks after final injection were 92% in the stable group and 93% in the transient group (P = 1.000). Neutralization response rates against CH505.w4.3 were also equivalent (92% vs 100%, P = .291). These data support transient transfection as an available tool for accelerating HIV vaccine testing and iteration. Clinical Trials Registration. NCT03856996.
利用瞬时转染细胞系可显著缩短蛋白质亚单位疫苗的生产时间线。本试验比较了通过上游稳定转染和瞬时转染生产的人类免疫缺陷病毒（HIV）包膜CH505TF gp120疫苗（每种均与TL4激动剂GLA-SE佐剂混合）的安全性和免疫原性。两种疫苗均安全且耐受性良好。末次注射后2周，稳定组血清IgG结合抗体反应率为92%，瞬时组为93%（P = 1.000）。针对CH505.w4.3的中和反应率也相当（92%对100%，P = 0.291）。这些数据支持将瞬时转染作为加速HIV疫苗测试和迭代的可用工具。临床试验注册编号：NCT03856996。
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