AEGiS-Chicago Tribune: STUDY: Doctors now wonder if the vaccine increases the likelihood of infection; At least 5 volunteers infected despite receiving AIDS vaccine Chicago TribuneImportant note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
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STUDY: Doctors now wonder if the vaccine increases the likelihood of infection; At least 5 volunteers infected despite receiving AIDS vaccine

Chicago Tribune - May 29, 1994
John Crewdson, Staff Writer


WASHINGTON-At least five volunteers in the government's principal AIDS-vaccine study have become infected with the AIDS virus despite receiving the vaccine. That has raised concerns not only about how well the vaccine works but whether it may have increased the likelihood of their infection and--in one case--even accelerated the progression of disease.

Scientists in charge of the study said infections with human immunodeficiency virus, which most researchers believe plays a central role in acquired immune deficiency syndrome, have been confirmed in two volunteers classified earlier as having a low risk for such infections, as well as three subjects whose lifestyles and sexual practices placed them in the group considered at high risk for AIDS.

One of the high-risk subjects, described as a woman whose sexual partner already was infected with HIV when she entered the study, and from whom she apparently later caught the virus, is said to since have undergone an unusually rapid decline in the number of white blood cells known as T-cells, the standard measure for the progress of AIDS.

None of the five cases has been reported so far in scientific literature. But they have been discussed at scientific meetings, including one closed-door session in Washington last month in which AIDS researchers from around the country met to debate whether the National Institutes of Health should go ahead with plans to test the vaccine on thousands of new, uninfected volunteers.

"We just don't know what we're going to do," said Dr. Jack Killen, the NIH official in charge of the vaccine trials, who acknowledged that the five post-vaccination infections had contributed to some researchers' doubts "that this is going to be a really good vaccine."

"The feeling is very mixed about the strength, duration and breadth of the immune response" demonstrated thus far by any of the candidate vaccines, Killen said. Four of the five infections, Killen said, have occurred in volunteers given one of the two vaccines, made by California companies Genentech and Biocene, that are under consideration for use in the expanded trials.

Both vaccines contain only a piece of the AIDS virus, called gp120, rather than the whole virus. Like other "sub-unit" vaccines that employ different pieces of the virus, the Genentech and Biocene products generate antibodies that, at least in theory, attack and neutralize the entire AIDS virus should it later appear.

Scientists do not understand why vaccine-induced antibodies which represent a potent weapon against nearly every other known virus, apparently fail to neutralize the AIDS virus.

"These five people are going to be studied with more intensity than anybody else has ever been studied," said Dr. Barney Graham, a Vanderbilt University researcher involved in the vaccine trials.

Graham described one of the two "low-risk" volunteers who became infected with HIV as "a monogamous person who later changed partners," thus raising his risk from low to high after the study had begun. No details could be learned about the circumstances of the infection sustained by the other low-risk volunteer.

Equally unclear is what the five infections mean for the future of subunit AIDS vaccines in general, the concept on which nearly a decade of AIDS-vaccine research has been based.
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