Italy moving
ahead on HIV vaccine tests

Encouraged by an initial trial, Italy wants to launch a large-scale human test of its HIV 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 a 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." 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. An effective preventative vaccine is seen as the best long-term hope for ending the AIDS pandemic, but one is not expected to reach market for many years.

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. The vaccine has been tested in both preventative trials and therapeutic trials to see if it can be used to treat people already infected with HIV as well as prevent the disease. In the initial tests, the vaccine was safe in 100% of volunteers. They had strong immune responses in more than 80% 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. (Reuters)