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

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

doi:10.1093/infdis/jiae558

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

J Infect Dis. 2024 Dec 13:jiae558. doi: 10.1093/infdis/jiae558. Online ahead of print.

Authors

Gregory J Wilson¹, L W Preston Church², Colleen F Kelley³, Samuel T Robinson², Yiwen Lu², Briana D Furch², Youyi Fong², Carmen A Paez², Margaret Yacovone⁴, Thomas Jacobsen⁵, Maureen Maughan⁵, Diana Martik⁵, Jack R Heptinstall⁶, Lu Zhang⁶, David C Montefiori⁷, Georgia D Tomaras^{6

8

9}, James G Kublin², Lawrence Corey²

Affiliations

¹ Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
² Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
³ Department of Medicine, Emory University, Atlanta, Georgia, USA.
⁴ National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
⁵ Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.
⁶ Duke Center for Human Systems Immunology, Departments of Surgery, Immunology, Molecular Genetics and Microbiology, Durham, North Carolina, USA.
⁷ Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.
⁸ Duke Center for Human Systems Immunology, Duke University School of Medicine, Durham, North Carolina, USA.
⁹ Duke Center for Human Systems Immunology, Department of Molecular Genetics and Microbiology, Duke University School of Medicine, Durham, North Carolina, USA.

PMID: 39671174
DOI: 10.1093/infdis/jiae558

Abstract

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.

Keywords: HIV; manufacturing; protein; transfection; vaccine.

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Associated data

ClinicalTrials.gov/NCT03856996

Abstract

Associated data

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