The trial in India is part of a multi-country phase I clinical development program for tgAAC09, an investigational recombinant adeno-associated viral vector (rAAV)-based HIV/AIDS vaccine candidate, that is also underway in Germany and Belgium.
The other collaborators involved in the study are the Indian Council of Medical Research (ICMR) and National AIDS Control Organization (NACO), and researchers at Columbus Children’s Research Institute (CCRI) and The Children’s Hospital of Philadelphia (CHOP).
The trial is a placebo-controlled, dose-escalating safety study that will also monitor immune responses to the product candidate. Data from this study, in combination with data from the ongoing phase I trial in Europe, will help to guide future development of the vaccine candidate.
Targeted Genetics expects to report data from the European trial in the first half of 2005.
Preclinical studies of tgAAC09 demonstrate that the vaccine induces anti-HIV T-cell and B-cell responses in animal models. Another promising area of development identified through preclinical studies is the potential to ‘boost’ the effect of the vaccine by administering two sequential doses.
“HIV/AIDS is a significant and growing health problem in India, as it is in many other parts of the world, and we are pleased to be collaborating with IAVI and the Indian Government in studying tgAAC09 in a region where development of an effective vaccine is essential,” said H Stewart Parker, president and CEO of Targeted Genetics.