Oral vaccine would be delivered by "bacterial robot" and be produced and sold for far less than other AIDS vaccine candidates

Embargoed for Release
Friday, May 19, 2000, 11 a.m.

Contact: Victor Zonana, IAVI: 212-847-1047, 917-406-5633 (cell)
Jennifer Schorr, IHV: 410-706-8614

Baltimore --The development of an innovative, orally administered AIDS vaccine by the Institute of Human Virology (IHV) will be funded by the International AIDS Vaccine Initiative (IAVI) under terms of a new multi-year, multi-million dollar vaccine development partnership agreement between the organizations.

IAVI and the IHV, a center of the University of Maryland Biotechnology Institute founded by Robert Gallo, co-discoverer of HIV, estimated that the new vaccine could be produced and sold for far less than other AIDS vaccine candidates currently in the pipeline. An inexpensive AIDS vaccine is a desperate need for developing countries, where 95% of new HIV infections occur.

At the same time, IAVI announced that it has formed a partnership with the Ministry of Health in Uganda to work with a number of scientific institutions in Uganda to further the development and testing of this and other IAVI-sponsored AIDS vaccine candidates.

The new vaccine will employ a "bacterial robot"--an innovative new technology that harnesses weakened Salmonella bacteria to deliver genetic material encoding the vaccine DNA to human cells in a process called bactofection. The cells then translate the genes into the actual vaccine.

Unlike delivery systems made from viruses, bacteria can hold large amounts of useful DNA, are highly stable, and are simple and inexpensive to manufacture. They also offer the potential to deliver vaccines orally or intranasally. As a result of being orally administered, the new vaccine is expected to elicit mucosal immune responses, which are likely to be the first line of defense against sexually transmitted HIV.

"This vaccine approach stresses ease of use and low cost, key factors for reaching people in developing countries," said Dr. Seth Berkley, MD, president of IAVI. Berkley also noted that, like IAVI's three previous vaccine development partnerships, the new agreement includes legal guarantees to help ensure that a successful vaccine will be distributed in developing countries for a reasonable price. (see IAVI fact sheet on intellectual property)


"An affordable AIDS vaccine is the world's best hope for ending the epidemic, especially in developing countries," Berkley said. Berkley added that the relatively simple manufacturing process could also eventually allow this vaccine to be produced in developing countries.

Gallo said, "We are excited to be teaming up with IAVI and the Ugandans to move this promising new vaccine technology forward. Bactofection has the potential to revolutionize the way we make vaccines in the future, inducing responses not only to microbes but to certain cancers as well. IAVI's fast-track philosophy and technical assistance will help speed this approach from the laboratory bench to the clinic."

"Uganda was the first country in Africa to host an AIDS vaccine trial," said Dr. Francis Omaswa, MD, Uganda's Director General of Health Services. "Our new partnership with IAVI will help ensure that we maintain our leadership in this area, doing whatever we can to accelerate the development and testing of AIDS vaccines appropriate for use in Africa," he added.

"The driving force for this decade-long effort has been the development of a simple delivery system for an HIV vaccine that can be administered without needles and that can be afforded by developing nations. Salmonella-DNA has these attributes built in from the start. We are extremely excited now to be able to evaluate this strategy in human volunteers," said Dr. George Lewis, Director of the IHV Division of Vaccine Research.

Lewis added that evaluation of the Salmonella-DNA vaccine approach in human volunteers stems from intensive basic research on the delivery of HIV vaccines by Salmonella. This research was carried out by Dr. David Hone, also of the IHV Division of Vaccine Research, in collaboration with Dr. Lewis and colleagues in Baltimore and Montana.

Dr. Wayne Koff, IAVI's Vice President for Research and Development, noted that the Salmonella-DNA vaccine approach "links two independent vaccine strategies (orally administered recombinant Salmonella vectors and DNA vaccines) with the goal of improving upon both for an effective vaccine appropriate for use in the developing world."

Koff said the new Salmonella vaccine will incorporate the IAVI-funded DNA vaccine that is being developed by IAVI's Oxford-Nairobi Vaccine Development. This will enable the Salmonella DNA vaccine to enter clinical trials faster, and to be compared directly with the injectable vaccine developed through the Oxford-Nairobi partnership. "Head-to-head comparisons of candidate vaccines in Phase 1 trials in developing countries is an integral component of IAVI's vaccine development program to accelerate the most promising candidate vaccines into efficacy trials in the shortest period of time," Koff added.

IAVI's scientific program seeks to maximize the number of promising vaccine candidates in clinical trials. Promising approaches lacking commercial sponsorship are prioritized and identified for funding by IAVI's Scientific Advisory Committee. At the heart of the scientific program is the Vaccine Development Partnership, a collaborative model that links scientists in industrialized and developing countries. IAVI provides funding, technical expertise, project management, and regulatory guidance to move promising approaches into clinical trials as rapidly as possible.




IAVI's research focuses on vaccines that would be most useful in developing countries. Such vaccines would be inexpensive to manufacture, easy to transport and administer, stable under field conditions and require few inoculations. IAVI has also negotiated agreements with its partners to ensure that vaccines will be made available in developing countries at just above the cost of manufacture. IAVI calls this approach "social venture capitalism." Unlike traditional venture capitalists, who seek equity in return for their investments, IAVI seeks a commitment that the vaccine, if successful, will be provided to the poor in developing countries at a reasonable price.

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The International AIDS Vaccine Initiative (IAVI) is nonprofit scientific and charitable 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 three areas: accelerating scientific progress, mobilizing public support through issue advocacy and education, and encouraging industrial involvement in AIDS vaccine development. IAVI draws most of its funding from governments, foundations and multilateral institutions. Its major donors include the Bill and Melinda Gates, Rockefeller, Starr and Sloan Foundations, the World Bank, and the governments of the United Kingdom and the Netherlands.

The Institute of Human Virology (IHV) at the University of Maryland was established to create and develop a world-class center of excellence focusing on chronic viral diseases and virally linked cancers. The IHV is dedicated to discovery, research, treatment, and prevention of these diseases and cancers. Its unique structure seeks to connect cohesive, multidisciplinary research and clinical programs so that new treatments are streamlined from discovery to patient. The IHV serves patients locally and the scientific community globally. The Institute of Human Virology was formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland, and the University of Maryland Medical System. It is a center of the University of Maryland Biotechnology Institute and affiliated with University of Maryland Medicine.

For more information, visit www.iavi.org and www.ihv.org.