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HVTN 123: A Phase 1, Randomized Trial Comparing Safety and Immunogenicity of CH505TF gp120 Produced by Stably and Transiently Transfected Cell Lines
The Journal of Infectious Diseases ( IF 5.0 ) Pub Date : 2024-12-13 , DOI: 10.1093/infdis/jiae558 Gregory J Wilson, L W Preston Church, Colleen F Kelley, Samuel T Robinson, Yiwen Lu, Briana D Furch, Youyi Fong, Carmen A Paez, Margaret Yacovone, Thomas Jacobsen, Maureen Maughan, Diana Martik, Jack R Heptinstall, Lu Zhang, David C Montefiori, Georgia D Tomaras, James G Kublin, Lawrence Corey
The Journal of Infectious Diseases ( IF 5.0 ) Pub Date : 2024-12-13 , DOI: 10.1093/infdis/jiae558 Gregory J Wilson, L W Preston Church, Colleen F Kelley, Samuel T Robinson, Yiwen Lu, Briana D Furch, Youyi Fong, Carmen A Paez, Margaret Yacovone, Thomas Jacobsen, Maureen Maughan, Diana Martik, Jack R Heptinstall, Lu Zhang, David C Montefiori, Georgia D Tomaras, James G Kublin, Lawrence Corey
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.
中文翻译:
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
利用瞬时转染的细胞系可以显著缩短蛋白质亚单位疫苗的生产时间。该试验比较了人类免疫缺陷病毒 (HIV) 包膜CH505TF上游稳定转染和瞬时转染(每种疫苗都与 TL4 激动剂 GLA-SE 佐剂混合)生产的 gp120 疫苗的安全性和免疫原性。两种疫苗都是安全且耐受性良好的。最后一次注射后 2 周血清 IgG 结合抗体反应率在稳定组中为 92%,在瞬时组中为 93% (P = 1.000)。针对 CH505.w4.3 的中和反应率也相当 (92% vs 100%,P = .291)。这些数据支持瞬时转染作为加速 HIV 疫苗检测和迭代的可用工具。临床试验注册。NCT03856996。
更新日期:2024-12-13
中文翻译:
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
利用瞬时转染的细胞系可以显著缩短蛋白质亚单位疫苗的生产时间。该试验比较了人类免疫缺陷病毒 (HIV) 包膜CH505TF上游稳定转染和瞬时转染(每种疫苗都与 TL4 激动剂 GLA-SE 佐剂混合)生产的 gp120 疫苗的安全性和免疫原性。两种疫苗都是安全且耐受性良好的。最后一次注射后 2 周血清 IgG 结合抗体反应率在稳定组中为 92%,在瞬时组中为 93% (P = 1.000)。针对 CH505.w4.3 的中和反应率也相当 (92% vs 100%,P = .291)。这些数据支持瞬时转染作为加速 HIV 疫苗检测和迭代的可用工具。临床试验注册。NCT03856996。