HVTN 123: A Phase 1, Randomized Trial Comparing Safety and Immunogenicity of CH505TF gp120 Produced by Stably and Transiently Transfected Cell Lines

• Published in: The Journal of infectious diseases 2024-12
• Main Authors: 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
• Format: Article
• Language: English
• ISSN: 0022-1899; 1537-6613; 1537-6613
• 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.