U.S. Scraps Plan to Test AIDS Vaccine
By MARILYN CHASE
July 18, 2008; Page B2
The U.S. National Institutes of Health scrubbed plans to test its AIDS vaccine due to concerns about its safety and effectiveness, 10 months after the collapse of a clinical trial for a similar vaccine from Merck & Co.
Thursday's move, the latest setback in a field pummeled by recent failures, is a sober recognition that questions still trump answers in the quest to prevent the spread of HIV, the virus that causes AIDS.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, a unit of NIH, cited concern about similarities between his agency's experimental vaccine and Merck's, which was shown to have made some who received it more susceptible to the disease. He also cited the continuing lack of knowledge about how to elicit immunity against the lethal virus.
Dr. Fauci is soliciting proposals for a "leaner, meaner" study with modest goals that would be a fraction of the size and cost of the original plan, which called for studying 8,500 people world-wide at a cost estimated at roughly $140 million.
More recently, the plan was scaled back to 2,400 volunteers at a cost of approximately $63 million. But Dr. Fauci said the trial should be even smaller, costing perhaps $38 million to $45 million. It wouldn't seek the ultimate goal of any vaccine-preventing disease, but instead aim to lower the level of virus in the blood.
"Tony's doing the right thing, resetting expectations," said Seth Berkley of the International AIDS Vaccine Initiative.
The canceled study, called PAVE-100, was seen as a promising test of the first truly global vaccine created by Dr. Gary Nabel of the NIH. The vaccine uses pieces of virus strains from around the world to spark immunity, but also uses the cold virus Adenovirus-5 to carry part of the vaccine's payload.
That Adenovirus-5 ingredient was implicated in the failure of the Merck vaccine test, in which people who got the vaccine became infected at a higher rate than those given a placebo, or dummy shot. Those shown to be most at risk were men previously exposed to the Ad-5 cold virus and those who weren't circumcised.
AIDS advocates scrambled to avoid a collapse of confidence -- and investment -- in pursuit of an AIDS vaccine, which is seen as the only way to end a deadly scourge affecting 33 million people.
"After a year of public hand-wringing and unproductive public attacks on the search for an AIDS vaccine, it is essential this decision not be viewed as a vote of no-confidence," said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition in New York.
"We're not going away," Dr. Fauci said. "I don't see this as chilling, but realistic."
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