WedSeattle, Washington, November 7, 2007, The AIDS Vaccine Advocacy Coalition (AVAC) released the following statement today from Executive Director Mitchell Warren in response to the release of new data from the STEP AIDS vaccine study by Merck & Co., the US National Institute for Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN) at a public forum at the HVTN meeting today.

The data from the STEP study released today confirm that the vaccine was not effective at either preventing infection in male volunteers or at reducing viral loads in male vaccine recipients who became infected with HIV during the trial. In addition, the data suggest that the vaccine may have made some volunteers more susceptible to acquiring HIV infection. The vaccine itself does not cause HIV. This trend was specifically observed among male volunteers who had high titers of antibody to adenovirus, the cold virus that was used, in a disabled form, in the MRK-Ad5 vaccine candidate.

“These data are deeply disappointing and troubling, and raise more questions than answers for the field of AIDS vaccine. Today’s discussion of the data underscores the leadership and transparency that Merck, NIAID, and HVTN continue to show in this complex and challenging time. What is clear is that the field must continue to work on this challenge and on the larger goal of finding a safe and effective AIDS vaccine.

“As much as we would like to see a clear answer in these results to whether or not the vaccine made some volunteers more susceptible to HIV infection, the reality is that there is still significant confusion about the underlying explanation for the observed effect.

“As we move forward, the work of analyzing and interpreting the data from the STEP study, and from the companion Phambili study in South Africa, will become even more difficult and even more important.

“In the 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 http://avac.org/pr_step_study.htm as the decision about unbinding the trial is made and as more analyses and data are released. 

New York and Johannesburg — The AIDS Vaccine Advocacy Coalition (AVAC) issued the following statement with regard to recent announcements about the Phambili AIDS vaccine trial in South Africa.

“We are deeply concerned by and share the disappointment of the field regarding the October 23 announcement that the immunizations would be stopped in the Phambili trial of Merck’s Ad5 candidate, and that volunteers in that study would be counseled that receiving the vaccine might have increased their risk of acquiring HIV infection,” said Mitchell Warren, AVAC executive director.

“This is a serious setback and heavy blow to the dedicated volunteers, principal investigators, and site staff who have committed their time, energy and optimismto this study. As always, we believe that participant safety is paramount and that where ever doubts arise, monitoring boards and trial sponsors must err on the side of caution.

“At this time, it is not clear whether or not there is definitive evidence that the vaccine did increase participant’s susceptibility. In the absence of this information, we must make sure that all participants in all of the trials of the Merck product understand the basis for the counseling messages about the possibility of increased susceptibility to HIV infection. We must also be cautious about leaping to definitive conclusions until the full data sets have been analyzed.”

On Tuesday, October 23, the South African AIDS Vaccine Initiative (SAAVI) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) issued press statements stating that the Data and Safety Monitoring Board (DSMB) for the Phambili trial [HVTN 503] had reviewed the available data from the STEP study of the same candidate, which halted immunizations in September, 2007.

As the NIAID press release stated, the DSMB made several recommendations: “The DSMB also recommended that HVTN 503 volunteers be told whether they received the vaccine or placebo, be strongly encouraged to return to their study sites for protocol-related tests, and be counseled about the possibility that those who received the vaccine may have an increased susceptibility to acquiring HIV infections.”

“It is very important that the field put forward clear common messages,” said Pontiano Kaleebu, AVAC board member, and principal investigator on AIDS vaccine trials at the Uganda Virus Research Institute. “The search for an AIDS vaccine must continue even when there is bad news. To move forward, all of us — communities, investigators, sites, the media — must work together to convey accurate messages based on the information available.”

Additional data set from the STEP study will be released in a public discussion on November 7, 2007, at HIV Vaccine Trial Network meeting in Seattle, Washington. This meeting will include data on rates and timing of infection from the second 1500 volunteers enrolled in the STEP study.

“It is hoped that exploration of this additional data from STEP will add to our understanding of what happened in that trial, and shed additional light on many questions, including whether vaccine recipients did indeed have increased risk of acquiring HIV,” said Warren.

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About AVAC
Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options. To help assure its independence, AVAC does notaccept funding from government or pharmaceutical industry sources. For more information, visit http://www.avac.org.

New York, September 21, 2007 — The AIDS Vaccine Advocacy Coalition (AVAC) released the following statement from Executive Director Mitchell Warren about the announcement that vaccinations have been discontinued in the STEP Study, a test-of-concept trial of the MRK-Ad5 AIDS vaccine candidate developed by the Merck Research Laboratories:

“Today’s announcement about the STEP Study is a deep disappointment and a scientific setback for the AIDS vaccine field. However, it must be seen for what it is: the failure of a product to show efficacy in a specific trial. Clinical testing of AIDS vaccines is a scientific process and, while this is a disappointment, it is in no way the end of the search for an AIDS vaccine.

“These data are certainly not the ones that we had hoped for. The entire HIV vaccine field, including AVAC, had been looking to STEP and its companion Phambili trial in South Africa, to provide initial evidence of vaccine-related benefits. Even as the data disappoint, we also note the success of the STEP Study trial design in providing a swift answer to the critical question of whether or not the vaccine provided any benefits. A successful clinical trial is one that produces a scientifically accurate result. It may not be the result you had hoped for, but it answers questions that help the field move forward.

“We applaud Merck’s tremendous leadership on HIV vaccine research. The company has set an example for the field, taking on one of the most important health technology challenges of our time. Merck and its collaborator, the US NIH-funded HIV Vaccine Trials Network, have been committed, strategic and willing to take risks at every stage of evaluating MRK-Ad5, and they must be commended for this. AVAC also recognizes the contributions of the thousands of volunteers in these trials. Their altruistic involvement makes HIV vaccine research possible. It is essential to build on what has been learned here and proceed with further research as rapidly as possible. Millions of lives are at stake.

“In the next weeks and months the AIDS vaccine field will need to make carefully-considered decisions about whether to move forward with planned trials of related vaccine strategies, and how to proceed with the Phambili trial, which has paused immunizations and enrollment. AVAC is committed to working with many other stakeholders in the AIDS vaccine field and in other areas of AIDS prevention research to ensure that these discussions are thoughtful, transparent, and clearly communicated to global audiences.

“These results do not change our fundamental view. Developing an AIDS vaccine will require a series of large-scale human trials in many different countries over a number of years. These trials need to be designed to produce clear results and to design better candidates in the future. This research must be complemented by ongoing studies of other new biomedical prevention strategies, and by full-scale, fully-funded implementation of proven prevention and treatment strategies.”

About the STEP Study
An interim analysis of data from the study, involving over 3,000 people testing an adenovirus-based vaccine (MRK-Ad5) developed by the Merck Research Laboratories, showed no efficacy in protecting against new infections or in reducing viral load in people who received the vaccine and went on to become infected. The study was scheduled to end in 2009. Periodic reviews of data by an independent monitoring board are part of the clinical trials process, and the study was halted on the recommendation of the STEP Study monitoring board after a regularly-scheduled review.

There have been two previous efficacy trials of an AIDS vaccine candidate, called AIDSVAX. Both of these studies took more than five years from launch to announcement of the finding, that the candidate did not protect against infection. The STEP Study enrolled its first participant in December 2004, and we have a definitive answer less than three years later. Getting swift, precise answers about candidates is crucial for the field. In this sense, the STEP Study fulfilled its purpose, as disappointing as the results may be.

One reason for this efficiency is that both STEP and its companion trial Phambili, which tested the candidate in South Africa, were designed as “test-of-concept” trials, to give an initial answer about vaccine benefits in a relatively abbreviated timeframe. The STEP Study met its enrollment targets and its endpoint goals within the timeframe specified by the trial planners. 

New AVAC Report on the State of the AIDS Vaccine Field Calls for Accelerated Action in AIDS Vaccine and HIV Prevention Research

Seattle — The AIDS Vaccine Advocacy Coalition (AVAC) announced today at the AIDS Vaccine 2007 Conference that it has received a five-year, $14 million grant from the Bill & Melinda Gates Foundation to create a new international HIV Prevention Research Advocacy Network.  The Advocacy Network will work with civil society, policymakers, and research partners around the world to advance ethical research and development of new HIV prevention interventions, ensure that communities are informed about and involved in prevention research, and ensure that the benefits of research are shared globally.

The new grant broadens AVAC’s advocacy focus beyond AIDS vaccines, to include other new HIV prevention interventions such as microbicides and oral prevention drugs.

“We are entering a new era in HIV prevention research, with more products being tested in efficacy trials than ever before,” said Mitchell Warren, Executive Director of AVAC.  “A coordinated global effort is urgently needed to support the wide range of prevention research, to ensure that the voices of civil society and communities are heard, and to prepare for results from these trials.”

“It is essential to build support for and understanding of how new HIV prevention tools will help accelerate efforts to slow this epidemic,” said Joe Cerrell, Director of Global Health Advocacy for the Gates Foundation.  “AVAC has been an important voice in AIDS vaccine advocacy for the last decade, and we are extremely pleased to support this broadening of its work.”

“This generous grant from the Gates Foundation will allow AVAC to expand our advocacy efforts and build a global network of advocates who will work to promote HIV prevention research and help communities prepare for the use of new HIV prevention options,” said Mike Powell, President of the AVAC Board of Directors.

AVAC remains committed to advocacy for effective AIDS vaccines, and will now be able to expand its work.  The new international HIV Prevention Research Advocacy Network will:
� Develop international advocacy partnerships that support both the needs of communities involved in research and a global advocacy movement for HIV prevention research.
� Translate complex scientific ideas to communities AND translate community needs and perceptions to the scientific community.
� Work to hold both research agencies and advocates accountable for accelerating ethical prevention research and development.
� Help ensure that communities, policymakers, and civil society have realistic expectations about HIV prevention research and specific clinical trials.
� Work closely with other groups conducting HIV prevention research advocacy, including microbicide advocacy groups.

“With so many clinical trials of HIV prevention interventions underway or planned in the next few years, there is an urgent need for a global advocacy network that will expand and support partnerships among the different groups working in the field,” said Lori Heise, Director of the Global Campaign for Microbicides.

Developing and maintaining strong support for clinical research of new HIV prevention interventions can be difficult in many communities and countries, but is necessary if ethical research is to take place in these communities.  The Advocacy Network will link advocates, researchers, and policymakers from around the world and will share information and identify and promote “good practices” for advocacy and clinical research.

“This network will provide an important knowledge base for those of us working on and supporting clinical trials in our communities,” said Manju Chatani, coordinator of the African Microbicides Advocacy Group. “We look forward to working with AVAC and other partners to strengthen HIV prevention research advocacy here in Africa and in communities around the world.”
Resetting the Clock — New AVAC Report Examines State of the AIDS Vaccine Field and Calls for New, Ambitious Deadlines for Vaccine Development

AVAC also released its annual report examining the state of the AIDS vaccine field today at the AIDS Vaccine 2007 Conference.  The new report, entitled Resetting the Clock, outlines the specific deadlines and challenges facing the field in the arenas of AIDS vaccine scientific strategy, clinical trials, and the broader prevention field and provides recommendations for action by researchers, policymakers, industry, funders, civil society, and advocates, including AVAC.

The report also discusses progress and challenges of the Global HIV Vaccine Enterprise, an alliance of independent partners committed to accelerating the development of an AIDS vaccine. AVAC is one of the founding stakeholders of the Enterprise.

“We will soon have data from the test-of-concept studies of novel AIDS vaccine candidates,” said Warren.  “It is time to reset the clock to launch a countdown for meeting new, ambitious deadlines for developing new vaccine concepts and candidates that will be needed whether or not there is evidence of benefit from these first test-of-concept trials.”

Key features of Resetting the Clock include:
� New Countdowns looks at progress and barriers in funding and strategy-setting for the vaccine field, addresses key questions about what needs to be done as we wait for the results from current trials, and looks at the responsibilities of key institutions.  It also includes an updated industry survey.
� Racing Against Time examines clinical trials issues and finds that the field is already in danger of slipping behind on several fronts, including clinical trials capacity, consensus on standards of prevention and levels of care, and new funding structures for US prevention research networks.
� Wake Up Call explores the critical lessons to be learned from responses to male circumcision and HPV vaccine introduction.  It also includes a survey of advocates from other areas of the AIDS response about prevention research.
“This report shows that the current state of HIV prevention research is troubling and challenging.  It is time for all AIDS advocates to re-exam�ine their messages, their missions, and their goals for the next five to ten years,” said Warren.  “We at AVAC remain committed to our advocacy for an effective AIDS vaccine and are excited about expanding the scope of our work to include the broader field of HIV prevention research and working with new partners around the globe to ensure that the world finds a way to defeat HIV/AIDS.”

Resetting the Clock is available online at http://www.avac.org/reports.htm.

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About AVAC
Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options. For more information, visit http://www.avac.org.

Call for new urgency, targets and leadership to accelerate research on HIV Vaccine Awareness Day

New York, NY — On May 18, 1997, US President Bill Clinton called for a concerted effort to develop an AIDS vaccine within a decade. This year we mark the 10th anniversary of that call for action with a global AIDS epidemic that rages on, and without a preventive HIV vaccine.

“Over the past decade, we have seen great progress in AIDS vaccine development, and we now see signs of great hope for development of a vaccine,” said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC). “But we have fallen short of the goal set out by President Clinton. Critical elements of the accelerated, comprehensive effort that we need to deliver on the promise of an AIDS vaccine are missing.”

In its special HIV Vaccine Awareness Day report, “The Countdown Continues” (available at http://avac.org/pdf/hvad_the_countdown_continues.pdf), AVAC identifies key issues and obstacles to an accelerated, comprehensive approach to AIDS vaccine development and challenges vaccine researchers, advocates, and funders to:

�    Accelerate and better coordinate research and testing of vaccines and other potential new HIV prevention technologies.
�    Sustain clinical trial capacity internationally, especially in communities where the HIV epidemic is most severe.
�    Develop bold and well-resourced plans for vaccine research and community education in all populations at high risk for HIV infection, not only those who are “easier” to reach.
�    Prepare for results of current AIDS vaccine efficacy trials by examining different efficacy scenarios.
�    Ensure that research results of all current trials are widely shared in order to help develop better next generation AIDS vaccine candidates.
�    Urgently expand access to proven HIV prevention options and treatment for all who need them.
�    Bring new, young investigators into AIDS vaccine research.

Ten years ago, President Clinton said, “[W]ith the strides of recent years, it is no longer a question of whether we can develop an AIDS vaccine, it is simply a question of when.”  While the dream of having that vaccine in the first decade of the 21st century has not come true, the world has, nonetheless, made tremendous advances in the past decade.
Global resources for AIDS vaccine development, while still short of what is needed, have quadrupled; the number of countries with clinical trials capacity has expanded from North and South America and Europe to include Asia and Africa; and more than 25,000 brave men, women, and children have stepped forward to volunteer for AIDS vaccine trials around the world.

On this anniversary, AVAC reaffirms its commitment to advocacy for a new clinical trials paradigm that recognizes the need for partnerships that include those from scientific and non-scientific domains. These partnerships both improve research and ensure that communities can immediately benefit from the conduct of clinical trials whose ultimate goal , an AIDS vaccine , may still be years away.

“If we are to sustain the necessary momentum to develop and distribute an AIDS vaccine, advocates, activists, scientists, trial volunteers and concerned citizens must work together to create a new paradigm for AIDS vaccine research and development. We must get better at answering the �question of when,’ and be able to explain why it is taking so long to develop a vaccine. And we must also take every step necessary to ensure that delays are avoided, whether in product development, regulatory decisions, or manufacturing,” said Warren.
“If one candidate fails, we must ensure that communities everywhere know this is not the end of the road. We must be sure that there is another candidate moving steadily forward into clinical trials,” he added. “We will ultimately measure the search for an AIDS vaccine in decades, but both President Clinton’s sense of urgency and optimism must remain with us as we continue the countdown to a day when the AIDS epidemic is over.”

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About AVAC:
Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options. For more information, visit www.avac.org.

About HIV Vaccine Awareness Day:
Each year on May 18th, people around the world commemorate HIV Vaccine Awareness Day, an observance to recognize and thank the thousands of volunteers, community members, health professionals, researchers and scientists who are working together to find a safe and effective HIV vaccine. It is also a day to educate our communities about the importance of HIV vaccine research and development. More information at http://avac.org/hvad.htm.