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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 has been approved by the Ethical Committees of the participating clinical centers and enrollment can now take place. |
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| Read More... |
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| The trials in South Africa will start as preventive trials under the cooperation with the Department of Health of the South African Government. |
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| An International Advisory Board of Experts will be appointed for both trials in Italy and 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 (P001): Completed
(May 2005)
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Phase II in South Africa (ISS P-002) |
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Phase I-Therapeutic (T001): Completed
(June 2005)
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Phase II in Italy
(ISS T-002 and ISS T-003)
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| Second generation HIV-1 tat vaccine candidates |
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| Other sets of trials in planning will involve testing of second generation vaccine candidates. A Tat+Env combination vaccine will be the subject of one set of trials. Another set of trials will evaluate a vaccine that delivers Tat via microparticles. Both second generation vaccines will undergo clinical development in Italy and South Africa. Plans will be made in anticipation of Preventive Phase I clinical trials for both vaccines in both countries. As of November 2007, preclinical studies have been completed. Preparation of the dossier necessary to obtain approval for the clinical testing of the 2nd generation vaccine candidates in humans both in Italy and South Africa is ongoing. |
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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) |
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| Tat+Microparticles (Code T1-beta) |
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Status |
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Development |
- Advanced preclinical testing (monkeys)
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Phase I Preventive trial (ISS P-004) |
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- Dossier preparation for approval for human use
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