A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

Summary

Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part of the study is to understand how the body's immune system responds to lab-made antibodies against HIV when they are given in combination at different doses. The study also wants to see if the way the antibodies are given affects the immune response.

Timeline

Start

2021-11-15

Primary completion

2023-07-19

Completion

2023-07-19

Publications

• Mahomed S, Paez CA, Huang Y, Seaton KE, Yu C, Gillespie K, Miner MD, Karuna ST, Gamble T, Heptinstall J, Domin E, Tang H, Zhang L, Gao F, Yacovone M, Spiegel HML, Dumond J, Anderson MA, Piwowar-Manning E, Dye BJ, Tindale I, Proulx-Burns L, Trahey M, Takuva S, Takalani A, Bailey VC, Kalams SA, Scott H, Kosgei J, Delany-Moretlwe S, Kassim S, Laher F, Chirenje ZM, Musodza Y, Mhlanga F, Mkhize N, Weiner JA, Ackerman ME, McElrath MJ, Pensiero MN, Gama L, Barouch DH, Corey L, Cohen MS, Montefiori DC, Tomaras GD, Siegel M, Kelley CF; HVTN 140/HPTN 101 Study Team. Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, VRC07-523LS, and PGT121.414.LS infused intravenously or subcutaneously (HVTN 140/HPTN 101 part B): a phase 1, randomised trial. Lancet HIV. 2026 Jul;13(7):e452-e464. doi: 10.1016/S2352-3018(25)00356-X. Epub 2026 May 11.
• Seaton KE, Paez CA, Yu C, Karuna ST, Gamble T, Miner MD, Heptinstall J, Zhang L, Gao F, Yacovone M, Spiegel H, Dumond JB, Anderson M, Piwowar-Manning E, Dye B, Tindale I, Proulx-Burns L, Trahey M, Takuva S, Takalani A, Bailey VC, Kalams SA, Scott H, Mkhize NN, Weiner JA, Ackerman ME, McElrath MJ, Pensiero M, Barouch DH, Montefiori D, Tomaras GD, Corey L, Cohen MS, Huang Y, Mahomed S, Siegel M, Kelley CF; HVTN 140/HPTN 101 study team. Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A): a first-in-human, phase 1 randomised trial. Lancet HIV. 2025 Jun;12(6):e405-e415. doi: 10.1016/S2352-3018(25)00012-8.

Drugs

Indications