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CD40.HIVRI.Env + DNA-HIV-PT123 + Poly-ICLC
- Development stage
- Unknown
- Lead developer
- ANRS
- Modality
- Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
- Administration
- Intramuscular
01
Overview
The 'Combi 3 group' refers to a specific high-dose combination vaccine regimen evaluated in the Phase I ANRS VRI06 clinical trial (NCT04842682) for the prevention of HIV infection. This prophylactic strategy involves the co-administration of **CD40.HIVRI.Env**, a dendritic cell-targeting biologic consisting of a monoclonal antibody against the CD40 receptor fused to the HIV-1 Clade C ZM96 envelope antigen (gp140), and **DNA-HIV-PT123**, a DNA vaccine encoding multiple HIV-1 antigens including gp140, Gag, Pol, and Nef. The regimen is adjuvanted with **Poly-ICLC** (Hiltonol), a synthetic double-stranded RNA that acts as a Toll-like receptor 3 (TLR3) agonist to stimulate innate immune pathways and enhance the adaptive response. The 'Combi 3' designation specifically identifies the cohort receiving the 3.0 mg dose of the CD40-targeted fusion protein in combination with the DNA vaccine. Results from the trial indicated that the combination was safe and capable of inducing early and sustained anti-envelope cellular and humoral immune responses.
- Other names
- CD40.HIVRI.Env + DNA-HIV-PT123 + Hiltonol
02
Targets
CD40 (Cluster of differentiation 40 receptor)Env (HIV-1 envelope glycoprotein)Nef (HIV-1 Nef)Pol (HIV-1 Pol polyprotein)TLR3 (Toll-like receptor 3)Gag (HIV-1 Gag polyprotein)Human immunodeficiency virus type 1 reverse transcriptasegp140 (HIV-1 gp140)
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