Italian AIDS vaccine to be tested in South Africa
(ANSA) - Rome, April 19 - A ground-breaking Italian AIDS vaccine is to be tested in South Africa, the Higher Health Institute (ISS) said Tuesday. The ISS's AIDS research group led by Barbara Ensoli will work with South Africa's National Department of Health on the second stage of testing of the vaccine, the ISS said in a statement. Initially, Ensoli's team will work with 200 volunteers between the ages of 18 and 45 at a clinic at the Medical University of South Africa in the northern province of Gauteng while another test site is being prepared at Walter Sisulu University in the Eastern Cape.
The ISS will be looking first to corroborate preliminary test results that the so-called TAT vaccine can provoke an immune response, and second will be monitoring the vaccine's safety. "The test programme begins with encouraging premises," said ISS President Enrico Garaci. From tests in Italy, he said, the TAT vaccine had shown signs of being "a promising tool to improve immune functions in HIV-positive individuals".
In November researchers published early phase II test results from Italian clinics showing that the vaccine appeared to be working. "We have seen the vaccine reach parts where drugs cannot go," Ensoli said. "The vaccine seems to bring the immune system back into kilter". Ensoli noted that 48 weeks after the vaccine was given to the volunteers, "their parameters are still improving and it appears we have managed to stop the damage". Garaci said the results "corroborate our efforts" and "confirm our model of research, from the lab bench to the patient's bed". The second stage of testing began in late 2008 in 11 centres across Italy with 128 HIV-positive people between the ages of 18 and 55, both men and women. In 2006 Ensoli ended the first phase of research and reported that her AIDS vaccine had passed its initial tests with flying colours. She said all the Italian volunteers had shown a "100% response to the vaccine by producing specific antibodies". Ensoli's vaccine is considered ground-breaking because it adopts a new approach to fighting HIV, the virus that causes AIDS. Traditional vaccines seek to bolster the immune system, the aim being to boost the body's ability to fight off the disease. This approach, however, has been relatively unsuccessful against HIV, a virus good at mutating and reviving itself. Ensoli's 'TAT-protein' vaccine, on the other hand, attempts to block the spread of the infection and prevent the reproduction of infected cells. Ensoli believes the HIV virus needs TAT-proteins to be able to take root and spread. By targeting TAT-proteins her treatment might be effective against all strains of HIV. Results from studies of the vaccine on laboratory animals have shown the treatment could be a vital step forward in the fight against AIDS. The vaccine - described by eminent oncologist and former health minister Umberto Veronesi as "intelligent" - received the green light for human testing in 2003. Ensoli's technique is not without its critics, however. In August 2007 the American magazine Science reported that Ensoli had filed a suit against prominent immunologist Ferdinando Auiti accusing him of slander and seeking to tarnish her reputation. Aiuti, Science wrote, had repeatedly cited "critical errors" in the first experimental stages of Ensoli's vaccine. Aiuti said he was "surprised" about the suit, adding that he had "nothing personal" against Ensoli and that he had not changed his opinion on her experimental vaccine. photo: ISS AIDS lab
The ISS will be looking first to corroborate preliminary test results that the so-called TAT vaccine can provoke an immune response, and second will be monitoring the vaccine's safety. "The test programme begins with encouraging premises," said ISS President Enrico Garaci. From tests in Italy, he said, the TAT vaccine had shown signs of being "a promising tool to improve immune functions in HIV-positive individuals".
In November researchers published early phase II test results from Italian clinics showing that the vaccine appeared to be working. "We have seen the vaccine reach parts where drugs cannot go," Ensoli said. "The vaccine seems to bring the immune system back into kilter". Ensoli noted that 48 weeks after the vaccine was given to the volunteers, "their parameters are still improving and it appears we have managed to stop the damage". Garaci said the results "corroborate our efforts" and "confirm our model of research, from the lab bench to the patient's bed". The second stage of testing began in late 2008 in 11 centres across Italy with 128 HIV-positive people between the ages of 18 and 55, both men and women. In 2006 Ensoli ended the first phase of research and reported that her AIDS vaccine had passed its initial tests with flying colours. She said all the Italian volunteers had shown a "100% response to the vaccine by producing specific antibodies". Ensoli's vaccine is considered ground-breaking because it adopts a new approach to fighting HIV, the virus that causes AIDS. Traditional vaccines seek to bolster the immune system, the aim being to boost the body's ability to fight off the disease. This approach, however, has been relatively unsuccessful against HIV, a virus good at mutating and reviving itself. Ensoli's 'TAT-protein' vaccine, on the other hand, attempts to block the spread of the infection and prevent the reproduction of infected cells. Ensoli believes the HIV virus needs TAT-proteins to be able to take root and spread. By targeting TAT-proteins her treatment might be effective against all strains of HIV. Results from studies of the vaccine on laboratory animals have shown the treatment could be a vital step forward in the fight against AIDS. The vaccine - described by eminent oncologist and former health minister Umberto Veronesi as "intelligent" - received the green light for human testing in 2003. Ensoli's technique is not without its critics, however. In August 2007 the American magazine Science reported that Ensoli had filed a suit against prominent immunologist Ferdinando Auiti accusing him of slander and seeking to tarnish her reputation. Aiuti, Science wrote, had repeatedly cited "critical errors" in the first experimental stages of Ensoli's vaccine. Aiuti said he was "surprised" about the suit, adding that he had "nothing personal" against Ensoli and that he had not changed his opinion on her experimental vaccine. photo: ISS AIDS lab