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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06694753 | Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa. | PHASE1 | RECRUITING | 96 | — | — | Dec 15, 2025 | Mar 31, 2027 | May 7, 2026 | 6 | South Africa |
* Local and systemic reactogenicity signs and symptoms will be collected for a minimum of 7 days following receipt of any study vaccination. * AEs leading to early participant withdrawal or permanent discontinuation, SAEs, medically attended adverse events (MAAEs), and AESIs will be collected throughout the study. Additionally, all AEs will be collected for 30 days after any receipt of study vaccination.
• Proportion of vaccinees with VRC01- or BG18-class IgG B cells, and frequency of VRC01- or BG18-class B cells among IgG+ B cells in PBMCs or in germinal centers, at baseline and after each study product administration, as determined by B-cell phenotyping and BCR sequencing.
| Arm | Type | Description |
|---|---|---|
| Cohort 1A Group 1: mRNA-1645-eODGT8 + mRNA-1645-CoreG28v2 | EXPERIMENTAL | Participants will receive one injection of 10 mcg mRNA-1645-eODGT8 to be administered as a 0.5 mL IM injection into the deltoid at Week 0 and one injection of 10 mcg mRNA-1645-CoreG28v2 to be administered as a 0.5 mL IM injection into the deltoid at Week 8. |
| Cohort 1A Group 2: Placebo | PLACEBO_COMPARATOR | Participants will receive 0.9% sodium chloride to be administered as a 0.5-mL IM injection into the deltoid at Weeks 0 and 8. |
| Cohort 2A Group 3: mRNA-1645-N332GT5 | EXPERIMENTAL | Participants will receive 10 mcg of mRNA-1645-N332GT5 to be administered as a 0.5 mL IM injection into the deltoid at Weeks 0 and 8. |
| Cohort 2A Group 4: Placebo | PLACEBO_COMPARATOR | Participants will receive 0.9% sodium chloride to be administered as a 0.5-mL IM injection into the deltoid at Week 0 and Week 8. |
| Cohort 1B Group 5: mRNA-1645-eODGT8 + mRNA-1645-CoreG28v2 | EXPERIMENTAL | Participants will receive one injection of 30 mcg mRNA-1645-eODGT8 to be administered as a 0.5 mL IM injection into the deltoid at Week 0 and one injection of 30 mcg mRNA-1645-CoreG28v2 to be administered as a 0.5 mL IM injection into the deltoid at Week 8. |
| Cohort 1B Group 6: Placebo | PLACEBO_COMPARATOR | Participants will receive 0.9% sodium chloride to be administered as a 0.5-mL IM injection into the deltoid at Week 0 and Week 8. |
| Cohort 2B Group 7: mRNA-1645-N332GT5 | EXPERIMENTAL | Participants will receive 30 mcg of mRNA-1645-N332GT5 to be administered as a 0.5 mL IM injection into the deltoid at Weeks 0 and 8. |
| Cohort 2B Group 8: Placebo | PLACEBO_COMPARATOR | Participants will receive 0.9% sodium chloride to be administered as a 0.5-mL IM injection into the deltoid at Week 0 and Week 8. |
| Name | Type | Description |
|---|---|---|
| mRNA-1645-eODGT8 | BIOLOGICAL | eOD-GT8 60mer is a self-assembling nanoparticle composed of 60 subunits of the engineered HIV-1 gp120 outer domain germline targeting version 8 (eOD-GT8) fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 15-amino acid Glycine-Serine linker. eOD-GT8 60mer will be delivered using an mRNA lipid nanoparticle (LNP) platform. To be administered by intramuscular (IM) injection at doses of 10 or 30 mcg. |
| mRNA-1645-CoreG28v2 | BIOLOGICAL | core-g28v2 60mer is a nanoparticle composed of 60 protein subunits of an engineered core-gp120 fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 21-amino acid Glycine-Serine linker. Core-g28v2 60mer will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg. |
| mRNA-1645-N332GT5 | BIOLOGICAL | N332-GT5 gp151 is an HIV envelope glycoprotein gp151 trimer based on BG505 SOSIP MD39 (clade A) trimer with "germline-targeting" mutations added that confer the ability to bind germline precursors of BG18 class B cells. N332-GT5 gp151 will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg. |
| Placebo | BIOLOGICAL | Saline |
Inclusion Criteria: 1. Demonstrates an understanding of the study and is able and willing to complete the informed consent process. 2. 18 to ≤ 55 years old, on day of enrollment. 3. Available for clinic follow-up through the last clinic visit. 4. Willingness to undergo FNA and leukapheresis. 5. Agr...