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

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

Pharmaceutical study code

IAVI A001/14E02

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