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B-GT/17: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine |
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Company or sponsor |
International AIDS Vaccine Initiative (IAVI) |
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Pharmaceutical study code |
IAVI A001/14E02 |
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Phase |
I |
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Unicenter/multicenter study |
multicenter |
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| Clinical data | see table 2 | ||
Installation |
Centre Hospitalier Universitaire St Pierre, Brussels |
AZ Stuivenberg - |
Universitair Ziekenhuis Antwerpen |
Authorisation procedure |
contained use, first use (see relevant regulation) |
contained use, first use (see relevant regulation) |
contained use, new operation (see relevant regulation) |
Application number |
SBB 219 2003/0419 |
SBB 219 2003/0425 |
SBB 219 2004/1310 |
User(s) |
Prof. N. Clumeck |
Dr. E. Vets |
Prof. Dr. P. Jorens |
Receipt date |
10/06/2003 |
17/06/2003 |
06/01/2004 |
Biosafety Council meeting date |
10/07/2003 |
10/07/2003 |
10/07/2003 |
Authorisation date |
15/12/2003 |
28/01/2004 |
10/03/2004 |
Status |
trial running |
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