United Biomedical Inc. (UBI) announced Friday that it hasbegun Phase I studies of its prototype HIV vaccine in China andAustralia.
The studies are being conducted in healthy volunteers at highrisk for HIV infection. Thirty volunteers in the China studyhave received the primary immunization, and the vaccine waswell-tolerated, said Bruce Forrest, director of clinicaldevelopment at UBI of Hauppauge, N.Y.
Recruitment is under way for the study in Australia.
Two Phase I trials of the vaccine have been launched in the U.S.Data from a trial sponsored by the National Institutes of Healthinvolving 36 patients was reported earlier this week at theNIH's conference on Advances in AIDS Vaccine Development inAlexandria, Va. It found that three of 10 subjects receiving alow dose of the vaccine produced antibodies that couldneutralize a primary field isolate of HIV-1. Another trial isunder way at San Francisco General Hospital.
Wayne Koff, UBI's vice president of vaccine research anddevelopment, said the company is also preparing to launchsimilar trials in other countries in collaboration with the WorldHealth Organization. He said the trials are in preparation forlarge-scale efficacy trials of its multicomponent vaccine.
So far the company has tested a prototype single-componentvaccine, consisting of the V3 loop from a single HIV isolate. Thecompanies final vaccine will be a multicomponent versionconsisting of eight V3 loops from HIV isolates from all over theworld and a cellular immune component. It is expected toinduce antibodies against international isolates and inducecytotoxic T cells to kill the virus within T cells.
Koff emphasized that UBI's program "is directed towarddeveloping a safe and globally effective AIDS vaccine, incontrast to most other vaccine manufacturers, who indicated atthe AIDS Vaccine Conference that they are still targeting AIDSvaccine development for only industrialized countries due toeconomic considerations."
He told BioWorld that an HIV vaccine has to work in allcountries to be effective.
-- Brenda Sandburg News Editor
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