Home > Newsletters > RxTrials Institute Drug Pipeline Alert > Phase I Trial Program of HIV/AIDS Vaccine Program Expanded to India
RxTrials Institute Drug Pipeline Alert
Feb. 8, 2005 | Vol. 3 No. 27
Phase I Trial Program of HIV/AIDS Vaccine Program Expanded to India
Targeted Genetics, the nonprofit International AIDS Vaccine Initiative, the Indian Council of Medical Research and National AIDS Control Organization, and researchers at Columbus Children's Research Institute and The Children's Hospital of Philadelphia have announced the initiation of a Phase I trial in India of tgAAC09, an investigational recombinant adeno-associated viral vector (rAAV)-based HIV/AIDS vaccine candidate.
The trial in India is part of a multicountry Phase I clinical development program for tgAAC09 that is also underway in Germany and Belgium. The Phase I clinical trial is a double-blind, placebo-controlled, dose-escalating safety study that will also monitor immune responses to the product candidate. The study in India is designed to enroll up to 30 volunteers who are HIV uninfected and in good general health. Each volunteer will receive a single intramuscular injection into the upper arm.
Data from this study, in combination with data generated by the ongoing Phase I trial in Europe will help to guide future development of this vaccine candidate. Targeted Genetics expects to report data from the European trial in the first half of 2005.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.