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HIV Vaccine Trial Injects First Participant

Today, the 25th of May 2005, the first participant enrolled in the Maiteko a Tshireletso HVTN 059 Phase I HIV Vaccine Trial received their initial injection of the study product. Each participant will receive a total of three injections; the initial injection, at 1month and at 3 months.

The Botswana HIV Vaccine Unit is participating together with the Soweto HIV Vaccine Unit in an international multi-center Phase I HIV vaccine trial “HVTN 059”. The primary purpose of the trial is to evaluate the safety and tolerability of the study vaccine. A secondary purpose is to assess the immune response. The study vaccine AVX 101 is composed of a virus vector and an HIV gene insert. The gene insert is the gag gene of HIV-1 subtype C, the strain of HIV that is most common in sub-Saharan Africa including Botswana and South Africa. The trial in Soweto began enrolling the beginning of May 2005.

The key to this vaccine is the HIV gene insert (the gag gene of HIV-1 subtype C). We expect that when someone is given this kind of vaccine the HIV genes will tell the cells in the body to make certain HIV proteins. The body may then react to the presence of these proteins. The idea is to train the immune system to eliminate cells that show signs of HIV infection. If a person later becomes infected with HIV, the immune system could thus be prepared to respond.

A total of 96 participants will be enrolled (48 in the US, 48 in southern Africa). The Southern African Countries are Botswana and South Africa and each shall enroll about 24 participants each who should be healthy, HIV-1-uninfected adults aged 21 to 50 years of age. The trial will last about 2 years, with 12 months of active participation per volunteer.

“We in Botswana are proud to have joined the international effort to search for an efficacious and safe HIV Vaccine which is the real hope for a long lasting solution to the HIV scourge,” says Dr Moeketsi Makhema co-investigator on the trial for the Botswana HIV vaccine trials Unit. “We are particularly happy that we shall be participating jointly with South Africa on this protocol embracing the principle of commonness of purpose especially since our region currently has the highest HIV prevalence in the world.”

“We are excited about collaborating with Botswana in the quest to find an HIV vaccine that is appropriate for Southern Africa. It is important that scientists and researchers from this region work together and that we share research experiences that can only improve our countries strategies to combat HIV/AIDS,” says Dr Glenda Gray principal investigator for the Soweto HIV vaccine trials unit.
The Botswana HIV Vaccine Unit continues to recruit volunteers for the trial and anyone interested in learning more should contact the clinic toll free at 0800 600 606 or at 3913579. Interested individuals are also invited to visit the vaccine clinic at Princess Marina Hospital.

This trial is sponsored by AlphaVax, Inc. (Research Triangle Park, North Carolina. USA).

The HIV Vaccine Trials Network (HVTN) will run the trial. The HVTN is a global partnership of researchers, governments, pharmaceutical industries, academic institutions, and community members. The HVTN is dedicated to conducting international clinical HIV vaccine trials in the safest, most efficient way possible. The HVTN is funded by the National Institute of Allergy and Infectious Diseases (NIAID) a Department of the National Institute of Health, USA.



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