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.
Authors
- David C. Montefiori (ORCID: https://orcid.org/0000-0003-0856-6319)
- Thomas Jacobsen (ORCID: https://orcid.org/0000-0002-1523-3996)
- Diana Martik
- James G. Kublin (ORCID: https://orcid.org/0000-0003-1279-3741)
- Georgia D. Tomaras (ORCID: https://orcid.org/0000-0001-8076-1931)
- L. W. Preston Church (ORCID: https://orcid.org/0000-0001-8045-3920)
- Maureen F. Maughan
- Yiwen Lu (ORCID: https://orcid.org/0000-0003-4921-7406)
- Lawrence Corey (ORCID: https://orcid.org/0000-0002-2179-2436)
- Youyi Fong (ORCID: https://orcid.org/0000-0002-4230-6863)
- Jack Heptinstall (ORCID: https://orcid.org/0000-0002-3401-5935)
- Carmen A. Paez (ORCID: https://orcid.org/0000-0001-8640-6623)
- Samuel T. Robinson (ORCID: https://orcid.org/0000-0003-2356-9905)
- Briana D. Furch (ORCID: https://orcid.org/0000-0003-3018-1642)
- Colleen F. Kelley (ORCID: https://orcid.org/0000-0001-5611-0119)
- Margaret Yacovone (ORCID: https://orcid.org/0000-0002-6983-8560)
- Lu Zhang (ORCID: https://orcid.org/0000-0002-7492-6047)
- Gregory J. Wilson
Institutions
- Emory University (US)
- Duke University (US)
- Fred Hutch Cancer Center (US)
- Center for Human Genetics (US)
- Duke Medical Center (US)
- National Institute of Allergy and Infectious Diseases (US)
- Vanderbilt University Medical Center (US)
Publication Details
- Journal
- The Journal of Infectious Diseases
- Published
- 2024-12-13
- DOI
- https://doi.org/10.1093/infdis/jiae558
- Primary Topic
- Bacteriophages and microbial interactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institutes of Health
- Center for AIDS Research, University of Washington
- National Institute of Allergy and Infectious Diseases