American Foundation for AIDS Research, December 2003
Kristen Kresge

In a landmark paper published in Science magazine earlier this year, scientists and policy makers proposed a new strategy to expedite the search for an HIV vaccine. Placing an emphasis on efficiency, the authors of the paper called for all vaccine researchers to coordinate their efforts. This concept is being referred to as the "Enterprise," after the title of the article: "The Need for a Global HIV Vaccine Enterprise."

But according to Larry Corey of the HIV Vaccine Trials Network (HVTN) and the University of Washington, the proposed partnership remains unnamed. "I don't want to use the words ‘road map.' They don't seem to work very well," he said. However, the goal of the effort is clear. The question is, "What is needed to still speed up the process of development?" asked Corey, a co-author of the article.

In the opinion of all twenty-four authors, some necessary steps include standardizing the assessment of both preclinical and clinical vaccine candidates, introducing an international clinical trial system, and developing the resources and facilities required to manufacture a vaccine.

At a recent conference highlighting the development of HIV vaccines, researchers acknowledged perhaps more than ever before the complications and expenses of making an effective vaccine. At AIDS Vaccines 2003, Dr. Anthony Fauci—director of the National Institute of Allergy and Infectious Diseases (NIAID)—delivered a plenary presentation entitled "The Bumpy Road to an HIV Vaccine," quickly summarizing the current obstacles to vaccine development.

Fauci highlighted the need for a common set of experimental lab standards to evaluate vaccines so that all researchers could learn from the results and compare data from different studies. "Let's make sure these trials are compatible with each other. You're going to learn from empirical clinical trials. You may very well learn things to inform future clinical trials," said Fauci, another co-author on the article. A trial could prove a vaccine is ineffective and not be a failed trial, and "there is a phenomenally important difference there," he added.

Fauci also called for increased financial support. He issued an invitation to non-governmental organizations, and to the Bill and Melinda Gates Foundation in particular, to get involved in the Enterprise. Although industry representatives participated in discussions leading up to the Enterprise, none have committed to a definite role in its execution. And Fauci insists that their participation is critical.

"I call upon the other partners that want to join the Enterprise to step up to the plate and bring additional resources. Industry is an absolutely essential partner in the development of a vaccine," he stated. To inspire industry to participate, Fauci mentioned two major tenets of the Enterprise idea: clinical trial networks and manufacturing capabilities. He suggested that by making an established international network of clinical trial sites available to industry, taking the burden off of companies to develop trial sites, there would be an incentive for them to make their research and results more transparent.

Also by initiating the development of a global manufacturing capacity, for use when an effective vaccine is found, the Enterprise could remove some of the financial pressure from individual corporations. Fauci hopes that by giving industry access to trial sites and manufacturing capabilities, companies might be more willing to share their data with other vaccine researchers. But the pharmaceutical industry seems unconvinced so far.

"It's a very good concept, but that's all it is right now. Until the structure actually evolves, it is difficult to visualize," said Emilio Emini, senior vice president of vaccine research at Merck. But for now he feels that, "there are no a priori blocks to industry participating in those endeavors."

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