AIDS TREATMENT NEWS Issue #308, December 4, 1998
John S. James

DNA Plus MVA Vaccine

One of the research programs, led by researchers at Oxford University and the University of Nairobi, will combine two vaccines which may work well together. One consists of DNA for HIV core proteins; it is produced in genetically engineered bacteria. When injected, this DNA is taken up by cells in the body, which then produce those proteins-- hopefully stimulating the desired immune response against HIV. Four years of preliminary work have already been done in developing this vaccine.

The other technology to be used in this vaccine is MVA (modified vaccinia Ankara), a harmless virus used in smallpox vaccines. In this case, the vaccinia virus has been modified to encode certain HIV core proteins; the virus carries the DNA for these proteins into the cells. The virus does not replicate in humans, however.

In both mice and monkeys, this dual-vaccine approach has been shown to produce strong T-helper and CTL (cytotoxic T lymphocyte) responses. Phase I safety testing will be done at Oxford, followed by phase I, II and II/III trials in Kenya.

Other research teams are developing HIV vaccines which use the DNA or MVA technology, but this is the only project which will use them together. Another team at Oxford is using the two together, to develop a vaccine against malaria.

The VEE Replicon Vaccine

A second vaccine uses a delivery system called VEE replicon, first tested at the University of North Carolina at Chapel Hill and the U.S. Army Medical Research Institute of Infectious Diseases, and then in commercial development by AlphaVax Human Vaccines Inc. of Durham, North Carolina, for several diseases not including HIV. The IAVI project will fund the development of an HIV vaccine using this technology, which employs a non-virulent form of Venezuelan equine encephalitis virus (VEE) to carry HIV (or other) genetic material into human cells. The replicon does reproduce in human cells, but it does not produce infectious progeny. This vaccine produces both cellular and humoral immune responses, and targets lymphoid tissue.

This vaccine technology has protected monkeys against a highly pathogenic strain of SIV--providing better protection than otherwise achieved except with a live vaccine, which has safety problems. In a separate experiment, it also protected monkeys against the Marburg virus, which is related to Ebola.

Intellectual Property Innovation

IAVI has also developed innovative business arrangements on intellectual property, to combine "the best mechanisms of the for-profit and not-for-profit sectors to achieve our goals," according to Lita Nelsen, director of the technology licensing office of the Massachusetts Institute of Technology (MIT), who was IAVI's principal advisor on intellectual property issues.

The basic arrangement is that IAVI invests money in promising technologies, in return for rights or other agreements that assure that the results will be available to the public sectors of developing countries, at a cost based on production cost. This way the company gets needed investment at an early stage of product development--allowing it to move faster in producing the vaccine--without interfering with its most valuable market, which will be in the developed countries. "Developing country" is defined according to World Bank criteria, and the "public sector" means government and non-profit organizations in those countries.

"By addressing these issues early and systematically, IAVI seeks to more effectively advance its overall mission. For- profit companies are where most of the world's vaccine development expertise resides. IAVI and its partners are creating the win-win situation necessary to fully engage the expertise of the private sector in this challenge. In doing so, they may also be able to help others successfully negotiate these issues to ensure that development moves ahead rapidly and access issues are addressed early on." (from "IAVI Intellectual Property Backgrounder," November 26, 1998).

"The current paradigm, where vaccines are developed in the industrialized world and sold exclusively there at high prices to recoup R & D costs, should not be acceptable for any vaccine, and certainly not for AIDS," said IAVI's president, Seth Berkley, M.D. "Developing countries should not be forced to wait 10 to 15 years for an AIDS vaccine to trickle down to them. We need to start now to ensure that a successful AIDS vaccine will be made available simultaneously in developed and developing countries."

Funding

IAVI began in 1997, with funding from the Rockefeller Foundation and public support from Princess Diana. Other supporters include the Alfred P. Sloan, Starr, William H. Gates, and Until There's A Cure Foundations; the World Bank; UNAIDS; Fondation Marcel Merieux; the UK Government; Levi Strauss International; and Glaxo Wellcome, in addition to individual donors. Crusaid, the Elton John AIDS Foundation, and others have contributed to the vaccine development effort.

For More Information

More information on the International AIDS Vaccine Initiative, on the vaccines, and on the intellectual-property arrangements is available at http://www.iavi.org.
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