PROMISING ITALIAN AIDS VACCINE MOVING TOWARDS LARGER SCALE HUMAN TRIALS IN AFRICAJul 6, 2005 | www.Newsinferno.com According to the Aids Vaccine Advocacy Coalition, there are presently about 30 experimental AIDS vaccines being tested worldwide in small-scale human trials. Only around a dozen have moved to phase II where effectiveness is considered. Phase I trials focus on safety.
One particular vaccine from Italy has shown enough promise to encourage Italy’s National Health Institute to plan large-scale human testing in Africa. Those trials should last until 2010 or 2011.
To date, the vaccine had been in small-scale trials involving 47 volunteers at four clinics in Italy. Final results were anticipated to be ready in 2006 but, due to the fact that the drug was well tolerated in all subjects and because the immunogenicity results were “much better” than expected, the move to phase II was pushed up.
To date, only two vaccines have made it to large-scale testing on thousands of volunteers in high-risk populations and one of them has already been discontinued because it did not work.
The Italian vaccine acts directly on TAT which is a protein needed by the virus to replicate itself. So far, the vaccine has been safe in 100% of the test subjects with about 80% having a strong immune response.