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COMBI 1
- Development stage
- Unknown
- Lead developer
- Vaccine Research Institute
- Modality
- Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intramuscular
01
Overview
COMBI 1 is a combination HIV vaccine regimen evaluated in the ANRS VRI06 Phase I clinical trial. It consists of the co-administration of CD40.HIVRI.Env, a biological vaccine comprising an anti-CD40 monoclonal antibody fused to the HIV-1 envelope glycoprotein gp140 (Clade C, strain 96ZM651), adjuvanted with the Toll-like receptor 3 (TLR3) agonist Poly-ICLC (Hiltonol), and the DNA-HIV-PT123 vaccine, which encodes multiple HIV antigens including gp140, Gag, Pol, and Nef. Developed by ANRS Emerging Infectious Diseases and the Vaccine Research Institute (VRI), the regimen aims to target dendritic cells via the CD40 receptor to enhance antigen presentation and elicit robust humoral and cellular immune responses. Phase I results (NCT04842682) indicated that the combination is safe and induces early, sustained anti-Env cellular and V1V2 IgG responses in healthy HIV-negative volunteers.
- Other names
- CD40.HIVRI.Env + DNA-HIV-PT123 + Poly-ICLCCD40.HIVRI.Env + DNA-HIV-PT123 + Hiltonol
02
Targets
CD40 (Cluster of differentiation 40 receptor)Env (HIV-1 envelope glycoprotein)TLR3 (Toll-like receptor 3)Gag (HIV-1 Gag polyprotein)Nef (HIV-1 Nef)Human immunodeficiency virus type 1 reverse transcriptasegp140 (HIV-1 gp140)
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