Email Updates

You are here

IAVI A001

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
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