September 21, 2000
BONN, 21 September 2000—An AIDS vaccine candidate designed specifically for Africa and manufactured in Germany has been approved for human testing. Wayne Koff Ph.D., Vice President for Research and Development of the International AIDS Vaccine Initiative (IAVI), announced today that the Medicines Control Agency (MCA) of the United Kingdom has approved Phase I testing of an MVA vaccine based on HIV subtype A, the most common strain in Kenya and in many other parts of Africa.
The MVA, or modified vaccinia Ankara-strain, vaccine was designed by Dr. Tomas Hanke at the Medical Research Council Human Immunology Unit in Oxford and manufactured under contract by Impfstoffwerke Dessau-Tornau, GmbH (IDT), a pharmaceutical company in Rosslau, Germany. "Producing the required amounts of high-quality vaccine for this study is a relatively small contribution to the solution of the AIDS-problem", says Heinz Hofmann, executive manager of IDT. "A vaccine for Africa developed through advanced technology in Europe could, however, be a decisive step forward."
The MVA vaccine is the second component of a novel prime-boost vaccination strategy. The first component, a DNA vaccine, entered Phase I trials in Oxford, England at the end of August. Pending approvals from the appropriate Kenyan authorities it is hoped that the DNA vaccine will move into human trials in Nairobi, Kenya within the next six months. The German-manufactured MVA vaccine will first be tested in Oxford and then in Nairobi and then the two components will be tested as a combination in Oxford and in Nairobi.
Both vaccine candidates are the product of a partnership between the research teams of Professor Andrew McMichael of the Medical Research Council Human Immunology Unit at Oxford University in the United Kingdom and Professor J.J. Bwayo of the University of Nairobi in Kenya. The Oxford/Nairobi Partnership is the first of four vaccine development partnerships funded by the International AIDS Vaccine Initiative (IAVI), a global scientific organization dedicated to accelerating the development of AIDS vaccines for use throughout the world.
"Today's news provides further evidence that IAVI's model of public-private partnership is speeding up the search for a preventive AIDS vaccine," said Dr. Koff. "Under IAVI's sponsorship, two vaccine candidates have now moved from concept to clinic in less than two years, near record time for a such an accomplishment. This is also the first MVA vaccine for AIDS to be approved for human testing," Koff said.
According to Dr. Seth Berkley, President and CEO of IAVI, "IAVI is committed to filling the pipeline with promising AIDS vaccine approaches. The MVA approach has long shown exceptional promise, but was languishing in the laboratory. We are pleased to have been the catalyst to move it forward into the clinic."
According to Professor McMichael, "Preclinical studies with the combination of DNA + MVA validated the strategy that by combining the two vaccines, immune responses against the virus are optimized, compared with vaccinating with either DNA or MVA alone. These studies provided the rationale for IAVI's decision to fast-track both candidate vaccines into clinical trials."
The rationale for this approach comes from extensive studies of sex workers in Nairobi. Despite continuous 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. 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. Any vaccine trials on humans must go through rigorous safety and ethical protocols. With HIV we are insisting on even higher standards of safety and ethics. The proposed vaccine is not curative but preventive. It is inspired by findings by our scientists in Nairobi."
The German AIDS-Foundation, national partner of IAVI in Germany, praises the involvement of German business. "It is encouraging to see private companies from Germany successfully contributing to AIDS vaccine development", says Ulrich Heide, executive director of the foundation. "It is nevertheless disheartening to see how little the German government is doing to speed up the development of an AIDS vaccine for developing countries." In a common statement IAVI and the German AIDS-Foundation ask for an additional 50 Mio DM in Federal grants annually.
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 Netherlands, Canada and Ireland, the World Bank, the Bill and Melinda Gates Foundation, the Rockefeller Foundation, the Sloan Foundation, and the Starr Foundation.