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HIV-1 TAT VACCINES: CLINICAL TRIALS PLANS
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 The successful completion of Phase I studies of the Tat vaccine in Italy, allowed the progression to Phase II clinical studies in both Italy and in South Africa. |
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| The phase II therapeutic trial with the HIV-1 Tat vaccine is currently ongoing in Italy. |
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| Read More... |
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| The phase II therapeutic trial in South Africa is being organized in cooperation with the Department of Health of the South African Government. |
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| An International Advisory Board of Experts has been appointed for the trial in Italy and is being appointed for the trial in South Africa. |
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| First generation HIV-1 tat vaccine candidate: Tat alone (code T1-alpha) |
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Status |
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Development |
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Phase I - Preventive (ISS P-001): Completed in Italy
(May 2005)
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Phase II - Therapeutic in South Africa (ISS T-003) |
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Phase I - Therapeutic (ISS T-001): Completed in Italy
(June 2005)
Phase II - Therapeutic (ISS T-002): ongoing in Italy
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| Second generation HIV-1 Tat vaccine candidates |
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| Other trials in planning will involve testing of second generation vaccine candidates. A Tat+Env combination vaccine will be the subject of one trial in Italy. Both second generation vaccines will undergo clinical development in Italy and South Africa. As of November 2007, preclinical studies have been completed. The dossier for the clinical testing of the Tat+Env vaccine candidate in humans has been approved by the competent Italian regulatory agencies and a phase I preventive trial is starting in Italy. |
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| Tat+Env vaccine (code T2-alpha) |
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Status |
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Development |
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Preclinical (mice, rabbits, and monkeys) completed |
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Phase I preventive trial (ISS P-002) starting in Italy |
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Dossier preparation completed |
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| Tat+Microparticles (Code T1-beta) |
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Status |
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Development |
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Advanced preclinical testing (monkeys): completed
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GMP process development
Dossier preparation for approval for human use |
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