The National AIDS Research Institute (NARI) Pune will be taking up the phase II trials of the newly developed AIDS vaccine shortly. The Institute has successfully completed the first phase of human trials some time back.

According to the NARI sources, the human clinical trial of the injectable vaccine called tgAAC09, which began in February 2005, has proved to be safe and well tolerated among the 30 volunteers who had participated in the study. The preliminary immunogenicity data indicates modest responses to the vaccine, mostly observed with the higher dose of vaccine and the final results are in the process of being analysed, sources added.

Deputy director and principal investigator of the clinical trials, NARI, Dr Sanjay Mehendale told Pharmabiz "The phase I trial conducted at NARI, was part of a multi-country trial, including sites in Belgium and Germany and the vaccine has tested in 30 healthy volunteers. The decision to conduct further trial with this vaccine is currently under consideration."

The trial, conducted under the joint auspices of the National AIDS Control Organisation and the Indian Council of Medical Research (ICMR) and sponsored by the International AIDS Vaccine Initiative (IAVI), has tested the recombinant adeno-associated virus (AAV) based vaccine (tgAAC09) expressing HIV-1 subtype C genes.

The primary objective of the trial was 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. The tgAAC09, which does not contain HIV virus, is a preventive vaccine intended for people who are not infected with HIV and not for persons living with HIV. Before the trail in human beings the vaccine had tested in animal and proved to be safe, Dr Sanjay added.