Table 1.
Clinical Trials Investigating Broadly Neutralizing Antibodies for Prevention of Human Immunodeficiency Virus
| Study Product | Combination Arms | Clinical Trial Identifier | Scientific Description | Trial Status | Publication |
|---|---|---|---|---|---|
| VRC01 | NA | NCT01993706 | VRC 602: Phase 1 dose-escalation study of the safety and pharmacokinetics of a human monoclonal antibody, VRC-HIV MAB060-00-AB(VRC01), administered intravenously or subcutaneously to healthy adults | Completed | Ledgerwood et al (2015) [19] |
| VRC01 | NA | NCT02165267 | Phase 1 clinical trial to evaluate the safety and drug levels of a human monoclonal antibody, VRC-HIVMAB060-00-AB (VRC01) administered in multiple doses intravenously and subcutaneously in different dosing schedules to healthy, HIV-uninfected adults | Completed | Mayer et al (2017) [20] |
| VRC01; VRC01LS | NA | NCT02599896 | VRC 606: Phase 1, dose-escalation study of the safety and pharmacokinetics of a human monoclonal antibody, VRC-HIVMAB080-00-AB (VRC01LS) and VRC-HIVMAB060-00-AB (VRC01), administered intravenously or subcutaneously to healthy adults | Completed | Gaudinski et al (2018) [21] |
| VRC01 | VRC01 + HSV8-N | NCT02579083 | Phase 1, single-center study to assess the safety of MB66, a combined anti-HIV (VRC01-N) and anti-HSV (HSV8-N) monoclonal antibody film for vaginal application as microbicide | Recruiting | … |
| VRC01 | NA | NCT02716675 | Phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection among men and transgender persons who have sex with men | Completed | … |
| VRC01 | NA | NCT02568215 | Phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa | Active, not recruiting | … |
| VRC01 | NA | PER-019-16 | Phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection among men and transgender persons who have sex with men | Completed | … |
| VRC01; VRC01LS | NA | NCT02797171 | Phase 1 clinical trial to evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adult participants | Completed | … |
| VRC01 | NA | NCT03729752 | PET imaging of radiolabeled anti–HIV-1 envelope monoclonal antibody (VRC01) | Recruiting | … |
| VRC07-523LS | NA | NCT03015181 | VRC 605: Phase 1 dose-escalation study of the safety and pharmacokinetics of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered intravenously or subcutaneously to healthy adults | Completed | Gaudinski et al (2019) [22] |
| VRC07-523LS | VRC07-523LS + 10E8VLS | NCT03565315 | VRC 610: Phase I safety and pharmacokinetics study to evaluate a human monoclonal antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) administered alone or concurrently with MAB VRC- HIVMAB075-00-AB (VRC07-523LS) via subcutaneous injection in healthy adults | Suspended | … |
| VRC07-523LS | VRC07-523LS + PGT121 | PACTR201808919297244 | Phase 1 study to determine the safety and pharmacokinetics of the human monoclonal antibodies, VRC07-523LS and PGT121 administered subcutaneously to HIV-negative adults in South Africa | Enrolment completed: follow-up | … |
| VRC07-523LS | PGT121 + VRC07-523LS; PGT121 + VRC07-523LS + PGDM1400 |
NCT03721510 | Phase 1/2a study of PGT121, VRC07-523LS and PGDM1400 monoclonal antibodies in HIV-uninfected and HIV-infected adults | Recruiting | … |
| VRC07-523LS | PGT121 + VRC07-523LS; PGDM1400 + VRC07-523LS; 10-1074 + VRC07-523LS; PGDM1400 + PGT121 + VRC07-523LS |
NCT03928821 | Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adult participants | Active, not recruiting | … |
| VRC07-523LS | NA | NCT03735849 | Phase 1 clinical trial to evaluate the safety and pharmacokinetics of VRC-HIVMAB075-00-AB (VRC07-523LS) in the sera and mucosae of healthy, HIV-1–uninfected adult participants | Active, not recruiting | … |
| VRC07-523LS | NA | NCT03387150 | Multicenter, randomized, partially blinded phase 1 clinical trial to evaluate the safety and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults | Active, not recruiting | … |
| VRC07-523LS | PGDM1400 + PGT121 + VRC07-523L; PGDM1400 + PGT121 |
NCT03205917 | Phase 1 randomized placebo-controlled clinical trial of the safety, pharmacokinetics and antiviral activity of PGDM1400 and PGT121 and VRC07-523LS monoclonal antibodies in HIV-uninfected and HIV-infected adults | Active, not recruiting | … |
| VRC07-523LS | VRC07-523LS + PGT121.414.LS | NCT04212091 | Phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or subcutaneous infusions in healthy, HIV-uninfected adult participants | Not yet recruiting | … |
| CAP256V2LS | CAP256V2LS + VRC07-523LS CAP256V2LS + PGT121 | PACTR202003767867253 | Phase I dose-escalation study of the safety, tolerability and pharmacokinetics of a human monoclonal antibody, CAP256V2LS (VRC-HIVMAB0102-00-AB) administered intravenously to HIV-negative and HIV-positive women or subcutaneously alone and in combination with VRC07-523LS and /or PGT121 to HIV-negative women in South Africa | Not yet recruiting | … |
| PGT121 | NA | NCT02960581 | Phase 1 randomized placebo-controlled clinical trial of the safety, pharmacokinetics and antiviral activity of pgt121 monoclonal antibody in HIV-uninfected and HIV-infected adults | Completed | … |
| N6LS | NA | NCT03538626 | VRC 609: Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of a human monoclonal antibody, VRC-HIVMAB091-00-AB (N6LS), administered intravenously or subcutaneously with or without recombinant human hyaluronidase PH20 (rHuPH20) to healthy adults | Recruiting | … |
| 10E8 | NA | NCT03875209 | Phase 1 dose-escalation study of the safety, tolerability, pharmacokinetics, and antiviral activity of the bispecific antibody 10E8.4/iMab in HIV-1–infected and uninfected individuals | Recruiting | … |
| PG9 | NA | NCT01937455 | Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy men | Completed | Priddy et al (2019) [28] |
| 3BNC117 | NA | NCT02018510 | Phase 1, open-label, dose-escalation study of the safety, pharmacokinetics and antiretroviral activity of 3BNC117 monoclonal antibody in HIV-infected and HIV-uninfected volunteers | Completed | Caskey et al (2015) [16] |
| 3BNC117 | 3BNC117 + 10-1074 | NCT02824536 | Phase 1 study of the safety and pharmacokinetics of the combination of 3BNC117 and 10-1074 in HIV-uninfected adults | Completed | Cohen et al (2018) [17] |
| 3BNC117-LS-J | NA | NCT03254277 | Phase 1 first-in-human study of the safety and pharmacokinetics of 3BNC117-LS in HIV-infected and HIV-uninfected individuals | Active, not recruiting | … |
| 3BNC117-LS-J | 3BNC117-LS-J + 10-1074-LS-J | NCT04173819 | Safety and pharmacokinetics of the combination broadly neutralizing antibodies, 3BNC117-LS-J and 10-1074-LS-J, in healthy American and African adults | Recruiting | … |
| 3BNC117-LS-J | 3BNC117-LS-J + 10-1074-LS-J | NCT03554408 | Phase 1, dose-escalation, first-in-human study of the safety and pharmacokinetics of the subcutaneous and intravenous administration of 10-1074-LS alone and in combination with 3BNC117-LS in HIV-infected and HIV-uninfected Individuals | Recruiting | … |
| 10-1074 | NA | NCT02511990 | Phase 1, open label, dose-escalation study of the safety, pharmacokinetics and antiretroviral activity of 10-1074 monoclonal antibody in HIV-infected and HIV-uninfected individuals | Completed | Caskey et a (2017) [14] |
| 2G12 (C2G12) | C2G12 + C2F5 + C4E10 | ISRCTN64808733 | Randomized double-blind phase 1 study to assess the pharmacokinetics of C2F5, C2G12, and C4E10 when administered together in a gel vehicle as a vaginal microbicide | Completed | Morris et al (2014) [10] |
| 2G12 (P2G12) | NA | NCT01403792 | Double-blind, placebo-controlled, randomized, dose-escalation phase I safety study of a single vaginal administration of P2G12 antibody in healthy female subjects | Completed | Ma et al (2015) [12] |
| 2G12 (P2G12) | NA | NCT02923999 | Phase I dose-escalation trial to evaluate safety and reactogenicity of single intravenous administration of P2G12 | Not yet recruiting | … |
Abbreviations: AAV, adeno-associated viral vector; HIV, human immunodeficiency virus; iMab, ibalizumab; NA, not applicable; PET, positron emission tomography.
A blank cell in the publication column indicates that there are no published data currently available.