Italy Moving Ahead in Human Trials of Aids Vaccine

Last Updated: 2005-07-05 15:16:28 -0400 (Reuters Health) By Shasta Darlington

ROME (Reuters) - Encouraged by an initial trial, Italy wants to launch a larger-scale human test of its AIDS vaccine in Africa in the hope of having it ready for the market by 2011, the project's chief researcher said on Tuesday.

Barbara Ensoli of Italy's National Health Institute began the small-scale trial involving 47 volunteers at four different clinics in Italy in 2003 and was aiming for results in 2006.

"The information we've gathered allows us to affirm that the vaccine is safe and well tolerated in all subjects," Ensoli told a press conference to announce plans for phase II of the trials.

"We also had much better immunogenicity results than we expected, so we're going to move to phase II ahead of schedule," she said. Immunogenicity is the strength and breadth of an immune response.

The trial should finish by 2010 or 2011, Ensoli said.

Around 30 HIV vaccines are being tested in small-scale human trials around the world. Only a dozen have moved to phase II, when the focus shifts from safety to effectiveness, according to the U.S.-based AIDS Vaccine Advocacy Coalition (AVAC).

An effective preventative vaccine is seen as the best long-term hope for ending the HIV/AIDS pandemic but one is not expected to reach market for many years.

"Barbara's work is very important. Are they going to produce the first AIDS vaccine? We don't know," said Mitchell Warren, executive director of AVAC. "But finding out what doesn't work right now is almost as important as finding out what works."

Only two products have been the subject of large-scale experiments involving thousands of volunteers in high-risk populations, and one of those did not work.

Ensoli's vaccine is unique in that it acts on TAT, a protein essential for the replication of the virus, instead of trying to block the virus itself.

In the initial tests, the vaccine was safe in 100 percent of volunteers. They had strong immune responses in more than 80 percent of the experiments, Ensoli said.

Ensoli and Italy's ISS are in talks with the European Union and private investors for the 50 million euros needed to fund the second-phase trial that would be broadened in Italy and launched in South Africa. In total, the trials would involve between 500 and 2,000 volunteers.

"We think we are going to get funds to cover Africa, but we're still looking for Italy," Ensoli said.

Almost 40 million people worldwide were infected with HIV at the end of 2004, almost two-thirds of them in sub-Saharan Africa, according to the World Health Organization. The disease has already claimed almost 30 million lives and around 5 million people are infected every year.