French Scientist Injects Self With AIDS Vaccine
A French AIDS scientist has injected himself with a prototype AIDS vaccine, thus beginning the first human testing of a vaccine against the deadly illness, it was reported today.
The researcher, Dr. Daniel Zagury, a professor of immunology at the Pierre and Marie Curie University in Paris, has developed evidence of an immune response to the test vaccine. But that result is to be expected whenever a person with normal immune function is exposed to foreign proteins.
This preliminary result does not prove that the test vaccine has any protective value against the AIDS virus because Zagury has never been exposed to the lethal virus.
His self-experimentation was potentially dangerous because there was no way to predict whether he would suffer side effects, such as immune system damage or even the development of AIDS.
But so far, Zagury said he has suffered no ill effects from the injection last November, according to a letter he and 11 colleagues wrote to Nature, a British scientific journal.
“I had to be sure it was safe in myself” before giving it to anyone else, Zagury, 59, said in a telephone interview. “I am a scientist, a physician and an immunologist. I worked on this for three years. I am not crazy.”
Since November, Zagury has received a second injection of the test vaccine and expanded his tests to include a number of other French researchers as well as a “small group” of volunteers from Zaire. But he cautioned that much more research is necessary to see if the preparation is “a good candi date vaccine.”
Zagury’s results were described as encouraging by leading American AIDS vaccine researchers, who nevertheless expressed astonishment that he was actually conducting the tests. For such human tests to be conducted in the United States, approval by the U.S. Food and Drug Administration and the research institutions involved would have been needed. Several research groups are in the process of applying for such authorization.
“It would have been premature for us to do this,” said Dr. Bernard Moss of the National Institutes of Health. Moss provided Zagury with viral materials last year for monkey experiments that were apparently used by the French scientist in developing his test vaccine.
Vaccines, designed to protect healthy people from acquiring a disease, usually contain weakened or dead germs. Once injected into the bloodstream, they work by inducing the body’s immune system to produce protective molecules called antibodies as well as special white blood cells that can eliminate foreign organisms. Thus, an AIDS vaccine would stimulate the body to protect itself against the AIDS virus.
Some researchers said they were surprised by Zagury’s use of a live-virus vaccine made with recombinant DNA technology--a technique that has triggered debate about its potential hazards. One fear is that such a vaccine might cause recipients with weakened immune systems to develop a serious viral infection similar to infections seen in AIDS patients.
Live-Virus Vaccine Method
In the recombinant live-virus approach, genes from the AIDS virus are inserted into the vaccinia, or cowpox, virus, which normally is used to immunize humans against smallpox.
The live-virus vaccine method has attracted widespread interest in AIDS research because it is thought to stimulate a strong immune response. It also may be effective against multiple strains of the AIDS virus--an important consideration because the AIDS virus has been identified in numerous variations.
But the potential drawbacks of recombinant vaccinia preparations were highlighted just last week. Researchers at the Walter Reed Army Medical Center in Washington described the case of a military recruit infected with the AIDS virus who had not yet become ill. After receiving a smallpox shot, he developed a vaccinia infection throughout his body and then developed AIDS. He died a few months later.
A Dedicated Scientist
Because of such considerations, it is uncertain whether Zagury’s experiments will accelerate the pace of AIDS vaccine research. It is expected to take at least five to 10 years to develop a safe and effective AIDS vaccine that can be used throughout the world.
Zagury, who has collaborated on other AIDS research with Dr. Robert C. Gallo of the National Cancer Institute, a co-discoverer of the AIDS virus, is described by colleagues as a dedicated scientist who became passionately committed to fighting AIDS after witnessing the devastation caused by the disease in Africa. “He is doing all this for humanitarian reasons,” Moss said.
Other researchers expressed similar views. “He’s got a lot of guts,” said Laurence A. Lasky of Genentech Inc., a South San Francisco-based genetic engineering firm.
“I wouldn’t do it myself; I’m a more conservative person,” said Scott Putney of Repligen Corp., a Cambridge, Mass., research company.
A Maverick Figure
Zagury first emerged as a maverick figure in AIDS research after it was disclosed last year that he was secretly testing a therapy to boost the immune system of about 20 patients in Zaire who were already infected with the AIDS virus.
These experiments, which were approved by the Zaire government, involve removing white blood cells from the patients and then infecting the cells with massive amounts of the AIDS virus. The infected cells are killed with chemicals and then injected back into the patient’s muscles.
Zagury, who has previously refused to discuss the tests, said these patients are “doing well,” but he declined to elaborate.
Zagury’s self-experimentation followed tests of his vaccine preparation in monkeys, baboons and a chimpanzee, which the scientist said demonstrated the approach was “absolutely innocuous and harmless.”
After receiving the injection himself, Zagury monitored his immune system for adverse effects and evidence of response to the vaccine over a nine-week period. The immune response was strongest against the strain of the AIDS virus used in developing the vaccine but there was some response to “a very different strain” as well, according to the letter published in today’s issue of Nature.
Ongoing Tests
Zagury’s ongoing human vaccine tests are comparable to what scientists call a “Phase 1” trial, in which a small number of people are injected with an experimental vaccine and then closely monitored through blood tests and exams for possible side effects.
The next phases would be larger trials to determine dosage and whether the vaccine actually works.
The AIDS virus, which attacks the body’s immune system, is transmitted through contaminated blood, sexual contact and from infected mother to child. As of March 16, 32,825 Americans had contracted AIDS and 19,021 had died.
