NCT04173819

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults

Completed Phase 1, PHASE2 Last updated 6 May 2025

What this trial tests

Phase 1, PHASE2 trial testing 3BNC117-LS-J in HIV-1-infection in 225 participants. Completed in 1 September 2023.

Timeline

25 January 2019

Primary endpoint
1 September 2023

1 September 2023

Quick facts

Lead sponsor	International AIDS Vaccine Initiative
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	225
Start date	25 January 2019
Primary completion	1 September 2023
Estimated completion	1 September 2023
Sites	9 locations across South Africa, Rwanda, Kenya, United States, Uganda

Drugs / interventions tested

• 3BNC117-LS-J — full drug profile →
• 10-1074-LS-J
• Combination 3BNC117-LS-J and 10-1074-LS-J — full drug profile →
• Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1 — full drug profile →
• Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2 — full drug profile →
• Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 3 — full drug profile →
• Placebo
• Placebo

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

International AIDS Vaccine Initiative — full company profile →

Who can join

Adults 18 to 45, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels \>10 µg/ml for at least 3 months in HIV-uninfected participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.
   Corey L, Gilbert PB, Juraska M, Montefiori DC, et al · · 2021 · cited 457× · PMID 33730454 · DOI 10.1056/nejmoa2031738
2. Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review.
   Mahomed S, Garrett N, Baxter C, Abdool Karim Q, et al · · 2021 · cited 77× · PMID 32604408 · DOI 10.1093/infdis/jiaa377
3. Broadly Neutralizing Antibodies for HIV-1 Prevention.
   Walsh SR, Seaman MS. · · 2021 · cited 73× · PMID 34354713 · DOI 10.3389/fimmu.2021.712122
4. Broadly neutralizing monoclonal antibodies for HIV prevention.
   Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
5. Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition.
   Seaton KE, Huang Y, Karuna S, Heptinstall JR, et al · · 2023 · cited 30× · PMID 37300931 · DOI 10.1016/j.ebiom.2023.104590
6. The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol
   Lee MJ, Collins S, Babalis D, Johnson N, et al · · 2022 · cited 24× · PMID 35382844 · DOI 10.1186/s13063-022-06151-w
7. Neutralizing Activity of Broadly Neutralizing anti-HIV-1 Antibodies against Primary African Isolates.
   Lorenzi JCC, Mendoza P, Cohen YZ, Nogueira L, et al · · 2021 · cited 24× · PMID 33298542 · DOI 10.1128/jvi.01909-20
8. Strategies for eliciting multiple lineages of broadly neutralizing antibodies to HIV by vaccination.
   Mu Z, Haynes BF, Cain DW. · · 2021 · cited 20× · PMID 34742037 · DOI 10.1016/j.coviro.2021.09.015