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Also known as eOD-GT8 60mer mRNA
mRNA-1645-eODGT8 · 1 trial · 1 indication
* 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...
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| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
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| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
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| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
mRNA-1645-eODGT8 is an investigational mRNA vaccine being developed by Moderna, Inc. for the prevention of HIV infections. It is in Phase 1 clinical development and has not been approved by any regulatory agency. The candidate encodes HIV immunogens and is designed to be evaluated for safety and immune response in adults without HIV.
mRNA-1645-eODGT8 is being studied for the prevention of HIV infections. It is an investigational vaccine candidate, not an approved product, and is currently limited to clinical research in adults who do not have HIV and are in overall good health. Its intended use is prophylactic vaccination against HIV.
Moderna, Inc., which trades on the Nasdaq under the ticker MRNA, is the developer of mRNA-1645-eODGT8. The company is running the candidate through early-stage clinical testing as part of its mRNA vaccine pipeline in infectious disease.
mRNA-1645-eODGT8 is in Phase 1 clinical development. It is an investigational vaccine candidate and is not FDA approved. One Phase 1 trial is currently active and recruiting, with no completed trials reported for this candidate to date.
mRNA-1645-eODGT8 is being studied in one Phase 1 trial, NCT06694753, titled a safety and immunogenicity study of three mRNAs encoding HIV immunogens. The trial is recruiting 96 adult participants without HIV and in overall good health in South Africa. It is randomized, double-blind, and placebo-controlled.
The Phase 1 trial NCT06694753 is a randomized, double-blind, placebo-controlled study enrolling 96 adults without HIV who are in overall good health. Participants are 18 years of age or older, all sexes are eligible, and the study is being conducted in South Africa. The trial is currently recruiting.