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AIDS Vaccine Trial Begins in Entebbe, Uganda

February 10, 2003

Entebbe, 10 February 2003—A team of Ugandan Researchers at the Uganda Virus Research Institute (UVRI) in Entebbe has begun a trial of a series of preventive AIDS vaccines this week. The vaccines are the only ones in human testing that are tailored for the subtype of HIV most common in Eastern Africa. The Phase I safety trial in Entebbe will enroll 50 volunteers who are not infected with HIV. A number of volunteers have already stepped forward to participate in the trials, but more are needed.

Volunteers in Uganda will join those in the UK and Kenya, where trials of these vaccines have been ongoing for more than for two years. The vaccines do not contain HIV, and cannot cause HIV infection. The vaccine series is intended to be given to people uninfected with HIV. This Phase I trial is only the beginning of testing these vaccines; larger trials will be needed to determine if the vaccines will indeed protect people against infection from HIV.

The Uganda National Council for Science and Technology approved the trial last year. It was also reviewed and approved by the Science and Ethics Committee at UVRI and reviewed by UNAIDS.

The trial is part of a partnership between the International AIDS Vaccine Initiative and the UVRI. Last year IAVI and the Ministry of Heath agreed to work together to accelerate the development and testing of preventive AIDS vaccines for Uganda and the world. The trial will be conducted by a study team composed of nurses, counselors, physicians, social scientists and laboratory scientists and is led by Principal Investigator Dr. Pontiano Kaleebu. The team has undergone extensive training in Uganda, the US, the UK and Kenya.

The two vaccines—one a naked DNA formulation, the other constructed from a weakened pox virus, MVA—were developed as part of an IAVI-sponsored partnership between the research teams of the UK Medical Research Council’s Human Immunology Unit at the University of Oxford and the University of Nairobi in Kenya.

The vaccine is tailored for subtype A of HIV, the subtype of HIV that is common in Uganda and other parts of east Africa. This is significant because, although scientists do not yet know if an AIDS vaccine will need to be made differently for different regions, most vaccines in human testing are tailored for subtypes other than A.

Trials of the vaccine combination are ongoing in Kenya and the UK. If the vaccines continue to show promise in these early stage trials they will progress to larger scale trials in additional sites in Uganda and other parts of East Africa.

Uganda has been at the forefront of AIDS vaccine development. In 1999, it was the site of the first AIDS vaccine trial in Africa when the Aventis-Pasteur ALVAC AIDS vaccine candidate was given to 40 healthy volunteers. The ALVAC vaccine is now being tested in later stage trials in the US, Latin America and Thailand. A number of other preventive AIDS vaccine trials are planned for Uganda.

“Uganda has been a leader in accelerating prevention efforts for AIDS and was the site of the first AIDS vaccine trial in Africa. We are proud to be continuing to work towards finding a vaccine for Uganda and the world," said Dr. Pontiano Kaleebu, Principal Investigator of the trial. He added, “We are pleased to be working with IAVI and our colleagues in Kenya and the UK on this most important project. If this vaccine continues to show promise in these early trials we hope to accelerate to a larger efficacy trial in East Africa.”

“IAVI is proud to be working with Ugandan researchers on this project; they have done a superb job in preparing for this trial. We are also tremendously grateful to the many volunteers who have already stepped forward to help test these vaccines,” said Dr. Seth Berkley, President and Chief Executive Officer of IAVI. “We will need many more men and women from all walks of life to come forward to help find a vaccine to prevent AIDS,” added Berkley, who was assigned to serve as the Ugandan Ministry of Health epidemiologist from 1987 to 1990 while working for the Carter Center.

"We are excited that this trial is beginning here at UVRI. We believe that working together the partners in this project can reach our goal of a preventive AIDS vaccine for Uganda and the world," said Dr. Miph Musoke, Acting Director of UVRI.

"Uganda is leading the way in the search for an AIDS vaccine for Africa. It is important that the fruits of our work here be available to Ugandans as soon as a successful vaccine is created. Our agreement with IAVI ensures that a successful vaccine from this partnership will be made available in our country as soon as possible," said Prof. Francis Omaswa, Director General, Health Services.

"Uganda has long been at the forefront in responding to AIDS. It is only natural that we would be involved in the search for a vaccine to help end this epidemic, said Dr Kihumuro Apuuli, Director General, Uganda AIDS Commission.

Volunteer information seminars are conducted every Thursday from 5pm to 7pm in the Golf View Inn in Entebbe; anyone interested in learning more about the IAVI sponsored vaccine trial is invited to attend. More information is available at www.iavi.org/uganda

About the Uganda Virus Research Institute
The Uganda Virus Research Institute, founded in 1936, is a government institution under the Ministry of Health whose broad mission is to carry out scientific research concerning communicable diseases, especially viral diseases of public health importance, and to advise the government on strategies for control and prevention. A number of international organizations are collaborating with UVRI on HIV research. UVRI serves as a World Health Organization primary laboratory for HIV-1 isolation and characterization.

About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global nonprofit organization that sponsors cross-national research partnerships to develop and test novel candidates for a vaccine to prevent HIV/AIDS. IAVI also works to assure that future AIDS vaccines will be rapidly accessible to all. IAVI is a Collaborating Centre of the Joint United Nations Programme on HIV/AIDS (UNAIDS). IAVI’s major financial supporters include the Bill & Melinda Gates Foundation; the Rockefeller, Sloan and Starr foundations; the World Bank; BD (Becton, Dickinson and Company); and the governments of Canada, the Netherlands, United Kingdom, United States, Ireland, Denmark, Norway and Sweden.