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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Study 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
Date receipt dossier: 
10 Jun 2003
Pharmaceutical study code: 
IAVI A001/14E02
Company / Sponsor: 
International AIDS Vaccine Initiative (IAVI)
Phase: 
I
Treated organism: 
Humans
Indication category: 
Infectious disease
Disease: 
AIDS
Therapeutic approach: 
Immunotherapy
Genetic modification: 
genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1
Method of transfer of nucleic acid of interest: 
Adeno Associated Virus serotype 2
Administered biological material: 
Recombinant Adeno Associated Virus D (rep, cap)
Route of administration: 
Intramuscular
Locations in Belgium: 
Centre Hospitalier Universitaire St Pierre, Brussels - AZ Stuivenberg, SGS Biopharma Research Unit - Universitair Ziekenhuis Antwerpen
Type of procedure: 
Contained use only
Current status: 
Authorized