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Executive Summary

NIAID WILL RUN MULTIPLE VACCINE HIV THERAPEUTIC TRIAL instead of the Department of Defense, which had planned to use only one AIDS vaccine as originally conceived under a federal appropriation last year. According to the multi-candidate HIV vaccine Phase III clinical trial protocol, which was developed by the National Institutes of Health, "the choice of which candidates and the number of candidate vaccines to be compared to placebo will be determined after careful analysis of the ongoing Phase I trials and ACTG (AIDS Clinical Trials Group) 214." In addition to two MicroGeneSys gp160 vaccine strains, vaccines under consideration for the trial include: Immune Response/Rhone-Poulenc Rorer's Immunization Products Ltd. whole inactivated virion (the "Salk" vaccine); Genentech's gp120 vaccine; Chiron-Biocine's gp120 product; and Immuno AG's gp160 vaccine. On April 14, the Department of Defense reached an agreement to transfer a $20 mil. congressional appropriation to HHS to conduct a large-scale, Phase III trial of a gp160 HIV therapeutic vaccine. The transfer announcement followed a week of debate and speculation as to the future of the $20 mil. appropriation after DoD had indicated its intention to conduct a trial with only a single candidate, MicroGeneSys' gp160 vaccines. DoD's initial position went against recommendations put forth by NIH and FDA that the appropriate use of the money would be a multicandidate trial ("The Pink Sheet" Nov. 30, 1992, p. 8). However, the selection process for the multi-vaccine trial has been made more difficult due to MicroGeneSys and its development partner Wyeth-Ayerst's recent decision to pull out of ACTG 214. The trial is one of the main comparative studies of HIV therapeutic vaccines currently being pursued by the government. The firms cited concerns with the trial's dosing schedule as well as the primary endpoints under consideration for the study. Despite the withdrawal of the MicroGeneSys vaccine, ACTG 214 is expected to begin by mid-May with a Chiron-Biocine gp120 strain in place of the two MicroGeneSys gp160 strains. The trial will include two Genentech gp120 strains and two Chiron-Biocine strains along with an alum control arm. Initial results are expected within the next five months. NIAID announced April 15 that it will require manufacturers to donate their HIV therapeutic vaccines to participate in the Phase III multi-candidate trial. "To stay within the $20 mil. framework for the trial, and as recommended by the National Institutes of Health advisory committee, it will be necessary that the participating vaccine manufacturers contribute their respective vaccines to the trial free of charge," NIAID said. At a meeting of the gp160 advisory group in November, manufacturers with potential candidates for a trial -- Genentech, Immuno Ag and Chiron-Biocine -- announced their willingness to provide their products at no cost. MicroGeneSys is opposing the donation requirement. In an April 15 statement, the company said it views the NIAID requirement "as an attempt to drive MicroGeneSys from participation in the trial. MicroGeneSys is a small company of limited resources that has already donated more product to the cause of research than all of its competitors combined. Attacks on the company by NIH and others have hampered severely its ability to raise funds." Regarding the transfer, MicroGeneSys noted that it is the firm's understanding that the transfer does not accurately reflect the intent of Congress' legislation. MicroGeneSys, through the successful lobbying of former Louisiana Sen. Russell Long, was responsible for securing the $20 mil. for the firm's gp160 product in last October's DoD appropriation. NIAID plans to use the $20 mil. for a multi-candidate trial similar to one that the NIH gp160 advisory panel devised over the course of several months. The study will include approximately 12,000 individuals with CD4 counts between 200 and 500. Assuming a trial with three vaccine arms and one placebo arm, NIAID believes the study could cost from $14 mil. to $23.5 mil. The cost also will include CD4 cell count testing and virology processing. While NIAID is considering all of its clinical trial networks, a likely mechanism is the institute's Community Programs for Clinical Research on AIDS (CPCRA).

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