United Biomedical Inc. will soon begin Phase I clinical trials of an oralAIDS vaccine designed to stimulate an immune response at localmucosal sites _ the rectum and genital tract _ where sexualtransmission occurs. The National Institute of Allergy and InfectiousDiseases (NIAID) will fund the trials.One trial will be run by the NIAID AIDS Vaccine Clinical TrialsNetwork at Johns Hopkins University and the other by the Universityof Rochester AIDS Vaccine Evaluation Units. In all, 32 healthy adultvolunteers will be enrolled. The aim of these tests is to determineimmune response and safety.Hauppauge, N.Y.-based United Biomedical's AIDS vaccine research isbeing supported by Baxter International, Inc. of Deerfield, Ill. Baxteragreed in 1992 to finance up to $10 million of research anddevelopment on the vaccine. At the same time, Baxter acquired almost12 percent equity in the company. Baxter will have exclusivedistribution rights to the vaccine.A True VaccineUnlike some treatments in development that are billed as vaccines but,in fact, are intended to stop the spread of AIDS in the body, UnitedBiomedical intends for its vaccine to prevent infection in the first place,according to Wayne Koff, the company's vice president for vaccineresearch and development."Our goal is to induce an immune response not only in the blood butalso in the areas of the body where AIDS enters," Koff said.United Biomedical's treatment, Multicomponent Global AIDSVaccine, has three components. First, it is formulated as a cocktail oflipid-modified peptides designed to neutralize the many forms of HIV-1 virus in genetically diverse populations throughout the world.Second, it is intended to stimulate cytotoxic T-cell responses that willtrigger the body's immune system to attack the virus in the body.Third, it is intended to be administered as a microparticle, single-doseoral vaccine.Phase I trials of the first two components have already been initiated.In addition to the United States, trials are being conducted in China andAustralia. Similar trials will soon begin in cooperation with the WorldHealth Organization (WHO) in places designated by the WHO as AIDSvaccine investigation sites. By conducting trials at sites in manycountries, including those that are less developed, the company hopesto build the infrastructure that will allow it to proceed immediately withefficacy trials once the Phase I trials have been evaluated."We have chosen to evaluate each component individually in a Phase Ihuman trial in order to confirm the responses we have seen in animaltrials, before we combine them all into a single vaccine product," saidKoff, adding that Phase II trials might begin in about 18 months.United Biomedical's goal, Koff said, is not just to develop an AIDSvaccine, but to develop one that meets criteria specified by the FederalCoordinating Council for Science, Engineering, and Technology'sCommittee on Life Sciences and Health. Some criteria are practical: thevaccine should be safe, effective, and easy to administer. Others arescientific and relate to issues of immunity, the nature of the HIV virus,and other topics.The vaccine delivery system United Biomedical is developing may alsoserve as a model for the Children's Vaccine Initiative's goal of a singledose vaccine that would protect against all childhood diseases. "Theflexibility of the microparticle delivery system we have designedallows us to put in as many vaccines as we choose," Koff said. "Youcould have one peptide of AIDS vaccine, and one of influenza and oneof measles. You could encapsulate a number of vaccines in onedelivery system."
-- Philippa Maister
(c) 1997 American Health Consultants. All rights reserved.