drugset / Trial / NCT03856996
A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity of CH505TF gp120 produced from stably transfected cells to CH505TF gp120 produced from transiently transfected cells in healthy, HIV-1-uninfected adult participants.
Timeline
- Start
- 2019-05-23
- Primary completion
- 2021-03-16
- Completion
- 2021-09-07
Publications
- Wilson GJ, Church LWP, Kelley CF, Robinson ST, Lu Y, Furch BD, Fong Y, Paez CA, Yacovone M, Jacobsen T, Maughan M, Martik D, Heptinstall JR, Zhang L, Montefiori DC, Tomaras GD, Kublin JG, Corey L. 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. 2025 Apr 15;231(4):e764-e769. doi: 10.1093/infdis/jiae558.
- Wolfe LS, Smedley JG 3rd, Bubna N, Hussain A, Harper R, Mostafa S. Development of a platform-based approach for the clinical production of HIV gp120 envelope glycoprotein vaccine candidates. Vaccine. 2021 Jun 29;39(29):3852-3861. doi: 10.1016/j.vaccine.2021.05.073. Epub 2021 Jun 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Stable CH505TF gp120 | Vaccine | 100 ug | Intramuscular |
| Subject | Transient CH505TF gp120 | Vaccine | 100 ug | Intramuscular |
| Background | GLA-SE | Other / unclassified | 10 ug | Intramuscular |