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Phase II trails of new HIV vaccine to be held in South Africa

by Medindia Content Team on Nov 15 2005 8:58 PM

In a step further to combat the AIDS epidemic, South Africa's first Phase II HIV vaccine trials were launched by charitable group the International AIDS Vaccine Initiative (IAVI) and U.S.-based Targeted Genetics Corporation.

The trials will test the safety of "tgAAC09" is a preventive HIV vaccine candidate that is based on HIV subtype C, the subtype of the virus most prevalent in southern and eastern Africa, the two groups said in a joint statement on Monday.

Sub-Saharan Africa is the region hardest hit by AIDS, with more than 25 million people estimated to be infected with HIV, the virus that leads to the disease.

South Africa has the highest caseload of HIV in the world, with about one in nine of its 45 million population carrying the virus, while in neighbouring Botswana and Swaziland prevalence is as high as 40 percent.

"We are pleased that South Africa has taken a leading role in the testing of vaccine candidates given the medical and humanitarian promise a preventative vaccine holds," said Eftyhia Vardas, a doctor at the country's Perinatal HIV Research Unit, who will coordinate the trials.

Investigators test the immune response and acquire more data on safety during second phase trials on drugs that have already been proven safe during first phase tests. tgAAC09 is designed to elicit two different types of immune responses, an antibody response and a cell mediated response. The vaccine consists of an artificially made copy of the HIV virus and cannot cause HIV infection or Aids," the IAVI said on Monday.

The vaccine candidate, developed by U.S.-based Targeted Genetics, will be tested on 78 healthy volunteers at three sites in South Africa. The trial is expected to last 18 months.

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IAVI, a global non-profit organisation working to accelerate the development of an AIDS vaccine, estimates that around 30 preventative HIV vaccine candidates are in human trials in six continents.

The South African trial follows positive safety data received from "Phase I" tests conducted over the past two years in Belgium, Germany and India.

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This is the first Phase II HIV vaccine trial to be held in South Africa.


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