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  HIV-1 TAT VACCINES: CLINICAL TRIALS PLANS
CLINICAL TRIALS PLANS 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.
The phase II therapeutic trial ISS T-002 with the HIV-1 Tat vaccine has been completed in Italy.
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The phase II therapeutic trial in South Africa ISS T-003 has been organized and conducted in cooperation with the Department of Health of the South African Government and the patients' follow-up is currently ongoing after the completion of the treatment phase.
First generation HIV-1 tat vaccine candidate: Tat alone
Status
 
Development

 

Phase I - Preventive (ISS P-001): Completed in Italy (May 2005)
  Phase II - Therapeutic in South Africa (ISS T-003): treatment phase completed - patients follow-up ongoing
  Phase I - Therapeutic (ISS T-001): Completed in Italy (June 2005)

Phase II - Therapeutic (ISS T-002): completed in Italy (December 2012)

 

 

Second generation HIV-1 Tat vaccine candidates
Other trials in planning will involve testing of second generation vaccine candidates. Both second generation vaccines will undergo clinical development in Italy and South Africa. 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 (ISS P-002) has been completed in Italy.
Tat+Env vaccine
Status
 
Development

 

Preclinical (mice, rabbits, and monkeys) completed
  Phase I preventive trial (ISS P-002) completed in Italy in 11 healthy volunteers
  Dossier preparation completed

 

Tat+Microparticles
Status

Advanced preclinical testing (monkeys): completed

 

 

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