Apr 26 2006, 7:30 AM EST
News source: Business Wire
The Zambia Emory HIV Research Project (ZEHRP), the International AIDS Vaccine Initiative (IAVI) and Targeted Genetics Corporation (Nasdaq: TGEN) today announced the initiation of a clinical trial in Zambia to test the safety and immunogenicity of tgAAC09, a preventive HIV vaccine.This is the first preventive HIV vaccine trial to be conducted in Zambia, and will take place at the Zambia Emory HIV Research Project Center in Lusaka with Dr. Elwyn Chomba acting as the Principal Investigator. It is an early-stage, multi-national trial, also being conducted at three sites in South Africa and Uganda.
"Zambia is proud today to be among the leading countries in Africa to spearhead the testing of vaccine candidates, given their great potential for the prevention of HIV/AIDS," said Dr. Elwyn Chomba, ZEHRP and Principal Investigator for the trial.
"IAVI is pleased to be working with the excellent team at ZEHRP. Supported by the government of Zambia, and in collaboration with the scientific and medical community in Lusaka, the Zambia Emory HIV Research Project has contributed to HIV/AIDS prevention in the country," said Seth Berkley, President and CEO of IAVI. "The Zambia study, along with other vaccine trials worldwide, will help us all take the field one step further in our search for a preventive HIV vaccine."
The vaccine candidate, tgAAC09, was developed by Targeted Genetics, based in Seattle. The vaccine is based on HIV subtype C, the subtype of the virus most prevalent in southern Africa. tgAAC09 is designed as a preventive vaccine, intended to protect people not infected with HIV from contracting the disease. It is designed to elicit two different types of immune responses -- an antibody response and a cell-mediated response.
"Expanding the evaluation of tgAAC09 to another region in need further advances the development of this vaccine candidate. We continue to be optimistic about the potential of AAV-based vaccines in the fight against HIV/AIDS and are pleased to be working in partnership with IAVI and ZEHRP in support of the global effort to halt the HIV pandemic. This is another example of the kind of international collaboration that is critical to an expedited pursuit of an effective vaccine," said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics.
About the Vaccine Candidate
The vaccine candidate, tgAAC09, utilizes a recombinant adeno-associated viral vector (AAV) that was developed with and manufactured by Targeted Genetics. Under the terms of a public-private collaboration, IAVI is funding development, pre-clinical and clinical studies to test the vaccine. The early-stage trial follows positive safety data received from the Phase I trial conducted over the past two years in Belgium, Germany, and India where volunteers received a lower-dose range.
Targeted Genetics' AAV development process is based on a cell line which was designed by Philip R. Johnson, MD., at the Children's Research Institute on the campus of Children's Hospital, in Columbus, Ohio, USA. Dr. Johnson is now Chief Scientific Officer at the Children's Hospital of Philadelphia, Pennsylvania, USA.
About the Trial
The trial should take about 18 months to complete. At the Lusaka clinical trial site, 16 volunteers (men and women) who are in good health will be enrolled. IAVI estimates that there are 30 preventive HIV vaccine candidates in human trials on six continents.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization working to accelerate the development of a vaccine to prevent HIV infection and AIDS. Founded in 1996 and operational in 23 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI also advocates for a vaccine to be a global priority and works to ensure that a future vaccine will be accessible to all w
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