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Global Enterprise' for HIV vaccine research

By Bob Roehr

NIAID director Anthony Fauci called for "a moral commitment…to a vision, and a strategic plan to help accelerate the development of an HIV vaccine" in his plenary address to the AIDS Vaccine 2003 conference held in New York City September 18-21.
The concepts of what has become known as the "Global Enterprise" were first launched in an article last June in the magazine Science by two dozen authors, including Fauci. There was further discussion at a meeting in Airlie, Virginia in August, and over the next six months working groups will develop a strategic plan for the Enterprise.
Fauci said that key principles are a commitment to working together as a global community; "to ensure transparency and systematic communications platforms;" common laboratory standards to allow comparability between efforts and their integration into the larger scheme of research; and identifying and meeting human and physical infrastructure needs.
Participation in the Enterprise "is not by subscription, it is by community," said Jose Esparza, director of HIV vaccine activities with the World Health Organization (WHO).
"The real challenge is to change our behavior," added Larry Corey, a University of Washington researcher who is principle investigator for the international HIV Vaccine Trials Network (HVTN) that NIH supports financially.
Fauci called developing an HIV vaccine "clearly the most important, and indeed the most difficult and problematic challenge in AIDS research." In searching for correlates of protection,Ê "We are looking for something that isn't there."
Many people both within and outside of the research community believe that HIV vaccine research has been fragmented and disjointed. Work in the lab and in monkey studies has been done to differing standards and has used different assays or measuring tools so that it often is impossible to compare the results and reach broader conclusions.
"We have these clinical networks – let's make sure these trials are compatible with each other so that we don't waste time and resources," said Fauci.
NIAID received a mandate from Health and Human Services Secretary Tommy Thompson to coordinate all HIV vaccine research funded by the US government. It now is coordinating the CDC and military research efforts so that each retains its individual identities and strengths but is conducting research to common standards and operating procedures.
Perhaps the most expensive element of research is the ability to conduct phase III clinical trials that prove that a vaccine works. NIH is working with academic and organizational partners in developing countries to create that capacity.
"Industry is an absolutely essential partner," for Fauci, and "Taking away some of the risk" for industry in this area is part of NIH's mandate. But he also made clear, "If they want to utilize the many facilities that we have, we would like them to do it in a way that the knowledge that is gained is going to be helpful to the field."
"A trial could fail to get you a vaccine," he explained, "but it could allow you to learn a lot about what you are going to do" in future iterations. "That is why transparency, and harmonization, and common laboratory parameters are so important."Ê The Global Enterprise is a vehicle to promote those goals.

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