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AIDS Vaccine Advocacy Coalition Calls for AIDS Vaccine Field to Work Together to Analyze STEP Study Data and Determine Best Course to Move Forward
Date:11/7/2007

weeks and months to come, we look to the AIDS vaccine field as a whole to maintain a collaborative spirit and to commit all necessary resources to the critical work of understanding the potential explanations and implications for the trends observed in the STEP study.

"We commend the trial sponsors for their consistent commitment to the safety of the volunteers, which must be the top priority in this and every other HIV prevention trial. At every stage of this difficult process, trial sponsors and site-level staff must continue to clearly communicate key information about the data and the participants' potential risk to volunteers at every site.

"AVAC recognizes that these data leave the AIDS vaccine field with a range of difficult decisions. Going forward, we believe that the wisest course of action is also the most cautious. To safeguard future trials and volunteers, the trial sponsors and the field as a whole should take as long as is needed to analyze the data and attempt to come to more definitive conclusions about what these new data mean, before beginning efficacy trials of other vaccine candidates.

"In addition, if there is the possibility that unblinding the STEP study and informing every participant about whether he or she received the placebo or the vaccine will provide an additional safeguard for participants, then this is the course of action that should be taken. AVAC believes that ultimately the decision about unblinding the trial should be guided by the participants' own concerns and priorities.

"Above all, we must continue to see this for what it is: a major setback for the AIDS vaccine field, but one that can and must be overcome through rigorous scientific investigation, open communication with communities, and a firm commitment to the shared goal of reversing the course of the AIDS epidemic in our lifetimes."

AVAC will continue to provide updates, analysis and resource materials at

SOURCE AIDS Vaccine Advocacy Coalition
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