HIV-1 TAT, or derivatives thereof for prophylactic and therapeutic vaccination,

Vaccines based on viral regulatory gene products (Tat/Rev/Nef) have contained virus replication preventing disease onset.

Summary of Invention This invention refers to Tat as the active principle for a prophylactic and/ or therapeutic vaccine against HIV infection, the progression towards AIDS and the development of tumors and other syndromes and symptoms in subjects infected by HIV. Tat is in biologically active form either as recombinant protein or peptide or as DNA. More particularly, the invention refers to a vaccine based on HIV-I Tat as immunogen, inoculated as DNA and/or recombinant protein or as peptides, alone or in combination with other genes or viral gene products (Nef, Rev, Gag) or parts thereof, or in combination with various immune- modulant cytokines (IL 12, IL 15) or with the gene coding for an immune- modulant cytokine or part thereof. Tat, Nef, Rev, Gag and the immune- modulant cytokines are administrated both as a mixture of recombinant proteins, peptides or fusion proteins (Tat/Nef, Tat/Rev, Tat/Gag, Tat/IL- 12, Tat/IL-15) or as plasmid DNA. Solution to which problem (s) Vaccines based on viral structural products (Env/Gag/Pol) alone have failed to prevent infection by HIV/SIV. Vaccines based on viral regulatory gene products (Tat/Rev/Nef) have contained virus replication preventing disease onset. Biologically active HIV-1 TAT, both as a protein and as DNA, has been shown in monkey trials to be safe to induce both humoral and cellular immune responses and to block primary infection, thus preventing disease onset against a challenge with a highly pathogenic virus. Key applications - A vaccine for prophylactic and/or therapeutic use against HIV infection in humans. Stage of Development: - All preclinical studies have been completed and an IND was filed in 2002 - A Phase I study , showing safety and good immunological activity has been completed in June of 2005 and results are being currently analyzed. - cGMP production process to obtain biologically recombinant for of HIV-1TAT has been developed and clinical lots are being produced for $ 10 Million EU funded clinical trial program, coordinated by Dr. Ensoli, aimed at testing the immunogenic activity of vaccine candidates comprising structural and regulatory antigens including TAT HIV-1. - Preparatory studies are under way for a phase II study in Italy and Africa.

Phase I/II

Priority date: Dec. 1, 1997; granted in some countries, national phases in all others.

Developmental Partnership, Outlicense, Sale