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