Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04983030 | Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2022 | Feb 23, 2026 | May 29, 2026 | 6 | United States |
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
An Unsolicited AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
AESIs and potential AESIs are judged to be of special interest because of clinical importance, known or suspected class effects and include thrombotic events and symptomatic thrombocytopenia.
Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
Proportion of participants who remain off ART and maintaining plasma HIV RNA \<1000 copies/mL for at least two thirds of the time between 24 and 72 weeks of analytical treatment interruption (ATI).
| Arm | Type | Description |
|---|---|---|
| Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs | EXPERIMENTAL | Participants will receive Ad26.Mos4.HIV vaccine at week 0 and MVA-BN-HIV vaccine at week 12. The bNAbs PGT121, PGDM1400, and VRC07-523LS will be administered at week 24, and the bNAbs PGT121 and PGDM1400 will be administered at week 28. |
| Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus Placebo | ACTIVE_COMPARATOR | Participants will receive Ad26.Mos4.HIV vaccine at week 0 and MVA-BN-HIV vaccine at week 12. Placebo will be administered at week 24, and at week 28. |
| Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs | ACTIVE_COMPARATOR | Participants will receive Placebo at week 0 and 12. The bNAbs PGT121, PGDM1400, and VRC07-523LS will be administered at week 24, and the bNAbs PGT121 and PGDM1400 will be administered at week 28. |
| Name | Type | Description |
|---|---|---|
| Ad26.Mos4.HIV | BIOLOGICAL | Ad26.Mos4.HIV is a tetravalent vaccine containing Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins. |
| MVA-BN-HIV | BIOLOGICAL | MVA-BN-HIV is a monovalent vaccine comprising a single Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN®) vector encoding Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins. |
| PGT121 | BIOLOGICAL | PGT121 is a human mAb that targets the HIV-1 V3 glycan, centered on N332. |
| PGDM1400 | BIOLOGICAL | PGDM1400 is a human mAb that targets the HIV-1 V2 glycan, centered on N160. |
| VRC07-523LS | BIOLOGICAL | VRC-HIVMAB075-00-AB (VRC07-523LS) is a human monoclonal antibody (mAb) that targets the HIV-1 CD4 binding site. |
Inclusion Criteria: 1. Each potential study participant must pass the Test of Understanding (TOU), indicating that he or she understands the purpose of, and procedures required for the study, after reading the informed consent and after the investigator or designee has provided detailed information...