NIH institute to work with trial of AIDS vaccine, despite concerns

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Red alert: trials have begun of a new AIDS vaccine, produced using cells expressing gp120. Credit: P. BERMAN, VAXGEN INC

The US National Institute of Allergy and Infectious Diseases (NIAID) is to collaborate with large-scale, privately funded clinical trials of an anti-HIV vaccine developed by Genentech.

In 1994, NIAID declined to undertake such a ‘phase three’ trial itself, citing since-resolved concerns about the vaccine's safety — and continuing concerns about its efficacy. The vaccine is based on a part of HIV's protein coat known as gp120 (see Nature 369, 593; 1994).

This year, a trial of a modified version called AIDSVAX has gone ahead anyway, led by the Genentech spin-off company VaxGen (see Nature 391, 220; 1998). NIAID now says it will collaborate with the trial's sponsors to conduct scientific studies of its own.

NIAID, which is the leading supporter of AIDS research at the National Institutes of Health (NIH), plans, among other things, to bank cells from volunteers. This will allow later analysis of cases of breakthrough infection, and the charting of immune function in successfully vaccinated subjects.

NIAID's new willingness to be associated with the trial has won applause from activists — and barbs from scientists who say there is no evidence that the vaccine will work.

It's “a very positive development”, says Jeff Jacobs of the AIDS Action Council in Washington DC. “This alleviates some concern we had of VaxGen moving forward without the government's involvement.”

But some scientists are less sanguine. “What has changed is not scientific, it's political,” says Dennis Burton, a molecular biologist at the Scripps Research Institute in La Jolla, California, and an expert on antibody responses to HIV. Another prominent AIDS researcher, who declined to be identified, says: “If anything did come out of the trial, the NIH would be crucified for not having been involved.”

Anthony Fauci, the director of NIAID, insists that politics played no part in the decision. The institute will capture scientific information that could answer important questions — such as why the vaccine is ineffective, if that turns out to be the case — and that would otherwise be lost, he says.

“Our interest is based in trying to understand and learn anything we possibly can,” says Fauci. “It would be a shame if the only phase three trial [thus far] is executed and we don't get the optimum amount of information.”