Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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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mRNA-1645-eODGT8 is an investigational messenger RNA (mRNA) vaccine being developed for the prevention of HIV infections. It is designed to encode HIV immunogens and is currently being studied in adult participants without HIV who are in overall good health.
mRNA-1645-eODGT8 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the Nasdaq stock exchange. The company is conducting a Phase 1 clinical trial to evaluate the vaccine's safety and immunogenicity.
mRNA-1645-eODGT8 is currently in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to assess its safety and immune response.
mRNA-1645-eODGT8 is being evaluated in a Phase 1 clinical trial registered as NCT06694753. The study, titled 'Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa,' is recruiting 96 participants in South Africa.
mRNA-1645-eODGT8 works by delivering messenger RNA that encodes HIV immunogens, which are designed to stimulate the immune system to produce a protective response against HIV. The vaccine is administered to healthy adults to evaluate its ability to generate an immune response.