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Status
Completed
Phase
I
Principal Investigator(s)
Sanjay Mehendale, Nathan Clumeck & Jan van Lunzen
Objective
The purpose of this study is to determine safety and immunogenicity (ability to induce an immune response) of a novel HIV vaccine based on adeno-associated virus (AAV)
Prevention Option(s)
HIV Vaccine
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
One or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization
ARMs
Experimental
Description
Formulation buffer consisting of a buffered salt solution with potassium phosphate, calcium chloride, magnesium chloride, and HEPES
ARMs
Placebo Comparator
Official Code
Trial Sponsors
International AIDS Vaccine Initiative, Targeted Genetics Corporation, Children's Hospital of Philadelphia, Nationwide Children's Hospital
December 2003
January 2007
Enrollment
80
18
Years
50
Years
Population
Women
Men
Sites
National AIDS Research Institute
Pune
India
University of Bonn
Bonn
Germany
SGS Biopharma
Antwerpen
Belgium
St. Pierre University Hospital
Brussels
Belgium
University of Hamburg
Hamburg
Germany