The phase I clinical trials for an AIDS vaccine,which began on February_8, 2005 at the National Aids Research Institute (Nari) here, have been completed, with researchers confirming that the “whole exercise went off smoothly without any safety concern”, reported by Times of India.
The trial enrolled 30 healthy volunteers who were followed up for 12 months post-vaccination. The conduct of the vaccine trial went “smoothly”. No safety concerns were identified and the vaccine was “well-tolerated”.
In addition, a single administration of the vaccine at the doses evaluated in this initial study elicited modest immune responses in some volunteers. These preliminary data from the trial were presented at the AIDS Vaccine Conference in Amsterdam in September 2006. The final results from this study are now being analysed, a release from International AIDS Vaccine Initiative said here.
The phase I trial tested a recombinant adeno-associated virus (AAV)-based vaccine (tgAACO9) expressing HIV-1 subtype C genes.
It was primarily designed to evaluate the safety and tolerability of the vaccine at escalating dose levels as well as immune responses following vaccination in healthy adult volunteers who are not infected with HIV.
This trial was part of a multi-country testing, including sites in Belgium and Germany.