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Project San Francisco, the International AIDS Vaccine Initiative (IAVI), and the National Institutes of Health (NIH) Launch Rwanda’s First AIDS Vaccine Trial

November 21, 2005

KIGALI, Rwanda, November 21, 2005 —Project San Francisco, the U.S. National Institutes of Health (NIH), and the International AIDS Vaccine Initiative (IAVI) today announced the start of a clinical trial in Kigali, Rwanda of an AIDS vaccine targeted against multiple subtypes of HIV.  This is the first HIV/AIDS vaccine to be tested in the country.

The trial is being conducted by Emory University’s Project San Francisco, based in Kigali, in collaboration with IAVI/East Africa.  The candidate, developed by the U.S. National Institute of Allergy and Infectious Diseases’ (NIAID) Dale and Betty Bumpers Vaccine Research Center (VRC), part of the NIH, is designed as a preventive vaccine to protect uninfected people from getting AIDS.
“This marks an important stepping-stone in the global battle to stop the spread of the HIV/AIDS epidemic,” said Innocent Nyaruhirira, MD, State Minister for HIV/AIDS and other Epidemics. “Rwandan scientists are proud to be a part of the effort to find an AIDS vaccine, which would be the best solution to the AIDS crisis worldwide.”
The Kigali study is a small-scale trial, with a primary aim to evaluate the safety of the product.  Research goals also include gathering preliminary data on the ability of the candidate vaccine to stimulate immune responses against HIV/AIDS in Rwandan volunteers.  The vaccine has already been tested in similar trials in the U.S.; however, partners acknowledge the critical importance of trials in Africa to determine the candidate’s appropriateness for the region.  
“The acute awareness of the Rwandan public about the importance of AIDS prevention and the excellence of Rwandan facilities and investigators were clearly the main factors for our decision to launch the study in the country,” said Seth Berkley, MD, President and CEO of IAVI.  “The trial of NIAID’s promising vaccine reflects the successful alliance among U.S. and African government agencies, local communities, global organizations, and academic institutions. Only by leveraging all of our expertise and research capabilities will we be able to discover an AIDS vaccine.”
The VRC candidate incorporates HIV genes from three different subtypes (A, B, and C) of the virus.  These subtypes are most commonly found in Africa, the Americas, Europe, and parts of Asia, and represent about 85 percent of the HIV infections worldwide.  
The product comprises two components, which differ in how the HIV genes are packaged.  One contains naked DNA fragments from some of the HIV genes; the other consists of a respiratory virus, known as adenovirus, which has been weakened to be used as a vector to shuttle some of the same HIV gene fragments into the body.  Researchers are interested in evaluating the immune response when they first give the DNA component as a “prime” and then boost with the adenovirus component.  Because only portions of viruses are used, the vaccine cannot result in infection either with HIV or the respiratory virus.
This study of the NIAID VRC vaccine also is expected to be conducted at a site in Kenya.  The United States Military HIV Research Program plans to conduct studies with the same vaccine at sites in Uganda, Kenya, and Tanzania pending regulatory approvals.  In addition, the vaccine is also being evaluated in trials in Southern Africa, North America, South America, and the Caribbean through the HIV Vaccine Trials Network (HVTN).

Project San Francisco

Project San Francisco (PSF), an Emory University Rollins School of Public Health program, has been conducting HIV/AIDS research as well as providing clinical care and counseling for HIV-infected persons in Rwanda for nearly 20 years. PSF, established in Kigali by Dr. Susan Allen, runs an on-site couples’ voluntary counseling and testing facility, medical clinic, laboratory and pharmacy. The non-governmental organization, works closely with the Centre Hospitalier Kigali (CHK), the National HIV/AIDS Reference Laboratory, and the Ministry of Health’s Treatment and Research on AIDS Center.

International AIDS Vaccine Initiative

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 assure that a future vaccine will be accessible to all who need it.  IAVI's financial and in-kind supporters include the Bill & Melinda Gates Foundation, the Rockefeller Foundation, Alfred P. Sloan and Starr Foundations; the Governments of Canada, Denmark, the European Union, Ireland, the Netherlands, Norway, Sweden, the United Kingdom, the United States and the Basque Country; multilateral organizations such as the World Bank; corporate donors including BD (Becton, Dickinson & Co.), Continental Airlines and DHL; leading AIDS charities such as Crusaid, Deutsche AIDS Stiftung, and the Until There's A Cure Foundation; and other private donors such as the Phoebe W. Haas Charitable Trust B.

U.S. National Institute of Allergy and Infectious Diseases’ (NIAID)

NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services.  NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.