January 21, 2001
NAIROBI, Kenya, 27 January 2001—The first AIDS vaccine candidate designed specifically for Africa will enter clinical trials in Nairobi following an endorsement from the Government of Kenya. The trial was approved by Kenya's National Council on Science and Technology last month after being cleared by Kenyatta National Hospital's Ethics and Research Committee.
The preventive vaccine candidate is based upon subtype A of HIV, the most common strain in East Africa. The vaccine candidate is the product of an International AIDS Vaccine Initiative-funded partnership between the research teams of the Medical Research Council's Human Immunology Unit at Oxford University in the United Kingdom and the University of Nairobi.
It will be tested in a new, state of the art research facility at the University of Nairobi, which was officially opened by Kenya's Minister of Public Health, the Hon. Professor Sam K. Ongeri in December. Recruitment for the trial began in December, and several of the 18 volunteers needed for the Phase I trial have already been screened.
The partners also announced a new agreement under which all existing and future patents covering the vaccine candidate will be owned jointly by the Medical Research Council, the University of Nairobi and the International AIDS Vaccine Initiative (IAVI). The partners agreed to use their patent ownership to help ensure access to a successful AIDS vaccine in Kenya and in other developing countries.
"Global problems require global solutions," said Dr. Gro Harlem Brundtland, director of the World Health Organization and chair of the Global Alliance on Vaccination and Immunization. "A universally accessible AIDS vaccine is the best hope for controlling this epidemic—in Africa and throughout the world."
Dr. Brundtland added that vaccines have traditionally taken far too long to trickle down to countries that need them most. "I commend IAVI and its partners for planning ahead to assure global access to this vaccine should it prove to be successful," she said.
Dr. Seth Berkley, president and chief executive officer of the International AIDS Vaccine Initiative, said: "This is an important step forward in the quest for a globally accessible AIDS vaccine. Although more than 25 vaccine candidates have been tested in humans, this is the first one designed specifically for Africa, which has borne the brunt of this epidemic. IAVI's model of speed and flexibility has allowed the Oxford/Nairobi vaccine candidate to move forward in near record time—just over two years from announcement to testing in Nairobi. I wish to salute the volunteers in this trial. They are the true heroes of this endeavor."
"The decision to share ownership of all patents recognizes the unique contribution of Kenyan scientists to this endeavor," Professor Francis Gichaga, vice chancellor of the University of Nairobi, added. "With 500 new HIV infections in Kenyan each day, we must now move forward with urgency to test the safety and efficacy of this vaccine candidate."
Phase I testing of the subtype A DNA vaccine began in August in Oxford, when Dr. Evan Harris, a member of Parliament, became the first individual to be injected with the vaccine.
Prof. Andrew McMichael, head of the Medical Research Council's Human Immunology Unit in Oxford and one of the world's leading researchers in cellular immunity, said: "We are excited to begin trials in Nairobi for this approach. Our research indicates that this vaccine has a very good chance of stimulating cellular immune responses to HIV. Research also suggests that white blood cells activated by the vaccine can destroy virus-infected cells. For HIV, this approach may be more effective than the traditional vaccine approach of stimulating antibodies."
The rationale for this approach comes from extensive studies of sex workers in Nairobi and elsewhere. Despite frequent exposure to HIV, a small minority of these women has resisted infection over many years. "We hope this vaccine will stimulate the same strong cellular immune response to HIV that we have seen in these women," said Prof. J. J. Bwayo, who is chairman of the Department of Medical Microbiology at the University of Nairobi.
Bwayo said, "Until now, most AIDS vaccines have been made from strains circulating in the North, specifically, subtype B. The development of this vaccine begins to address the great need for vaccines designed specifically for Africa." He added: "We recognize that vaccine trials on HIV/AIDS present unique challenges. This trial has gone through rigorous safety and ethical protocols. With HIV we insisted on even higher standards of safety and ethics. The vaccine candidate is not curative but preventive. It is inspired by findings by our scientists in Nairobi."
The International AIDS Vaccine Initiative is an international non-profit scientific organization founded in 1996 whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. IAVI's work focuses on four areas: accelerating scientific progress, mobilizing support through advocacy and education, encouraging industrial involvement in AIDS vaccine development, and assuring global access. IAVI is a collaborating center of UNAIDS. Its major donors include the governments of the United Kingdom, the United States, the Netherlands, Canada, and Ireland; the World Bank; and the Bill and Melinda Gates Foundation, the Rockefeller Foundation, the Sloan Foundation, and the Starr Foundation.