HVTN 123：比较稳定和瞬时转染细胞株产生的 CH505TF gp120 的安全性和免疫原性的 1 期随机试验。

IF 5 2区医学 Q2 IMMUNOLOGY

Journal of Infectious Diseases Pub Date : 2025-04-15 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

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引用次数: 0

摘要

利用瞬时转染细胞系可以显著缩短蛋白质亚单位疫苗的生产时间。本试验比较了上游稳定转染和瞬时转染制备的人类免疫缺陷病毒（HIV）包膜CH505TF gp120疫苗的安全性和免疫原性（每种疫苗均与TL4激动剂GLA-SE佐剂混合）。两种疫苗都是安全且耐受性良好的。末次注射后2周血清IgG结合抗体应答率稳定组为92%，短暂组为93% （P = 1.000）。对CH505.w4.3的中和反应率也相同（92% vs 100%, P = 0.291）。这些数据支持瞬时转染作为加速HIV疫苗测试和迭代的可用工具。临床试验注册。NCT03856996。

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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.

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.

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来源期刊

Journal of Infectious Diseases 医学-传染病学

CiteScore

13.50

自引率

3.10%

发文量

449

审稿时长

2-4 weeks

期刊介绍： Published continuously since 1904, The Journal of Infectious Diseases (JID) is the premier global journal for original research on infectious diseases. The editors welcome Major Articles and Brief Reports describing research results on microbiology, immunology, epidemiology, and related disciplines, on the pathogenesis, diagnosis, and treatment of infectious diseases; on the microbes that cause them; and on disorders of host immune responses. JID is an official publication of the Infectious Diseases Society of America.