The trials were aimed at evaluating the safety and tolerability of the vaccine at escalating dose levels.
PUNE: 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." The trials were aimed at evaluating the safety and tolerability of the vaccine at escalating dose levels as well as immune responses in healthy adult volunteers not infected with HIV.
Thirty healthy adult volunteers, who had enrolled for the ambitious programme, were administered with the injectible vaccine, called tgAAC09 (recombinant adenoassociated virus (AAV) vector, expressing HIV-1 subtype C genes). The vaccine candidate was developed by a Pune researcher — Dr Pervin Anklesaria — at the Seattle-based Targeted Genetics Corporation, a biotechnology company developing gene therapy products for the treatment of acquired and inherited diseases, and Columbus Children's Research Institute in partnership with IAVI (International Aids Vaccine Initiative). "The conduct of the vaccine trial went smoothly. No safety concerns were identified and the vaccine was well tolerated," Sanjay Mehendale, deputy director of Nari and principal investigator of the clinical trials, said.