Subject: U. S. Will Begin Human Clinical Tests of AIDS Vaccine Date: Published: 8/19/87 113 lines Source: WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. U. S. Will Begin Human Clinical Tests Of MicroGeneSys Inc. 's AIDS Vaccine --- By Edward Sussman Staff Reporter of The Wall Street Journal WASHINGTON -- The federal government will conduct the preliminary human clinical tests of an experimental AIDS vaccine developed by West Haven, Conn.-based MicroGeneSys Inc. Details of the planned tests were disclosed at a news conference by officials from MicroGeneSys and the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health. The officials said the institute would directly supervise the first phase of the experiment, which will be the first U. S. -approved human clinical trial of a vaccine against AIDS, or acquired immune deficiency syndrome. The tests will occur at the institute's Bethesda, Md., headquarters. A total of 63 males, including 60 healthy homosexuals and three heterosexuals, will be inoculated with the vaccine. The Food and Drug Administration last week approved the vaccine for human testing. While the outcome of the experiment is far from certain, Franklin Volvovitz, president and chairman of closely held MicroGeneSys, said that results from animal studies suggest that research is "on the right track." Mr. Volvovitz has been trying to position MicroGeneSys as a front-runner in AIDS research. The first phase of the test program will focus on the safety of the vaccine and will monitor immunological response to it. In all, 81 volunteers will be recruited from the Washington, D. C., area, including those who will be inoculated and a control group. All the volunteers will be rigorously screened to ensure that they haven't been exposed to the AIDS virus, and they will be asked to promise to avoid engaging in high-risk sexual behavior for three months after the inoculation. Researchers will test the inoculated volunteers to see if they develop any of the antibodies that might prevent AIDS. However, even if the volunteers do develop these antibodies, it won't be certain whether they are actually immune from AIDS. Federal officials stressed that volunteers face no risk of contracting AIDS from the vaccine. The entire testing effort could last until the mid-1990s, the company said. The first phase of the experiment will last about six months. If it proves successful, a second phase, which would last about a year and would involve a wider group of volunteers, will follow. It would be designed to explore further the safety of the vaccine and the immunological response to it, and to determine the optimal dosage. If that phase is successful, a third stage involving thousands of volunteers nationwide could be started. Inoculating a large number of volunteers, researchers say, would make it likely that some actually would subsequently be exposed to AIDS. Only after this third phase is complete could it be scientifically established whether the vaccine is effective in preventing AIDS infection, according to Anthony Fauci, director of the national institute. To date, the MicroGeneSys vaccine has only been tested on animals. Tests on chimpanzees given doses 10 times greater than the dose to be administered to humans showed that the immunized animals developed some of the natural antibodies that might prevent AIDS. The chimpanzees didn't develop significant side effects. The immunized animals weren't exposed to the AIDS virus. Researchers said that because the AIDS virus causes different responses in chimpanzees than in humans, such an experiment would have been inconclusive. Dr. Fauci said that the first round of the experiment is being concentrated on homosexual males to gauge the vaccine's effects on the population that AIDS so far has hit the hardest. Many homosexuals have been exposed to different sets of viral agents than heterosexuals, giving them a unique immunological profile in which the vaccine would need to work, he explained. The MicroGeneSys vaccine uses a synthetic version of the outer coat of the AIDS virus. The synthetic outer coat is produced by taking a virus that infects moths and butterflies and making an engineered version of that virus containing the gene for the AIDS virus's outer coat. The engineered version is used to infect a culture of insect cells, turning them into tiny factories that make non-infectious replicas of the AIDS virus's coat. The protein coat, known as gp 160, would be used to "trick" the body into mounting an immune defense against the real AIDS virus. Several other companies are also pursuing research aimed at developing an AIDS vaccine, but so far only MicroGeneSys has received FDA approval for human testing. Separate research is also being conducted on developing drugs to treat those already infected with AIDS, which so far has infected 40,000 Americans and killed more than half of them. Throughout the world, some scientists estimate that as many as 10 million people have been exposed to the AIDS virus. The national institute has authorized six university-based vaccine evaluation units nationwide to study AIDS vaccines. While these sites might become part of the long-term testing in the future, MicroGeneSys contracted exclusively with the federal government's facilities for the first phase of the testing. For its services, the government will be paid a royalty by the company based on any profit the vaccine eventually makes. In the meantime, the federal government is paying for the research. 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