AVAC Reports

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2007 AVAC Report Resetting the Clock

Resetting the clock, this year’s AVAC Report title, is inspired by the anniversary of US President Bill Clinton’s 1997 speech calling for an AIDS vaccine in ten years’ time. Many organizations, including AVAC, marked this anniversary—and the expiry of the original deadline—with reflection and tempered optimism on May 18 of this year.

We recognize that the title could just as easily be the punch line of a joke about the AIDS vaccine field. Here at AVAC we frequently hear—and remark—that the timeline for finding an AIDS vaccine has been “5 to 10 years” for, well, 5 to 10 years. It seems that we are always resetting the clock.

Today we argue in all seriousness that it is time to reset the clock. We are within two to three years of data from three test-of-concept studies of AIDS vaccines, including the ongoing Thai prime-boost study and two trials of Merck’s adenovirus-based candidate. And so now is the time to set new, ambitious deadlines for developing the novel vaccine concepts and candidates that will be needed whether or not there is evidence of benefit from these first test-of-concept trials.

The three sections of this year’s report outline some specific deadlines and challenges in AIDS vaccine scientific strategy, clinical trials, and the broader realm of HIV prevention. These arenas mesh like watch gears, and must function just as smoothly if the field is to proceed.

For a printed copy of the 2007 AVAC Report please email your request to avacreport@avac.org.

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Table of Contents

Executive Summary

Letter from the Executive Director

- Figure 1. Global Coverage for Select HIV Prevention Strategies in 2005
- Figure 2. Global HIV Incidence With and Without Comprehensive Prevention Package

Key Recommendations

AVAC's Status Report - An Update on Last Year's Recommendations

Section 1: New Countdowns

In this section we explore progress and barriers in funding and strategy-setting for the field. As we wait for the results from upcoming trials, what else do we need to be doing? What are the responsibilities of key institutions at this critical time? We’ve addressed these questions and returned to industry for an updated survey of private-sector work. This section also discusses progress and challenges of the Global HIV Vaccine Enterprise.

- Figure 7. Anticipated Data Milestones and Proposed Needs for the Future

- Figure 8. Non-commercial Funding Allocations for Preventive HIV Vaccine R&D by Category in 2000-06

- Table 1. Test-of-Concept Versus Phase III: A Comparison

- Table 3. Industry HIV Vaccine Involvement 2007

- Figure 9. Global HIV Vaccine Enterprise Timeline 2003-07

Section 2: Racing Against Time
In this section we turn to clinical trial issues. Here we argue that the field is already in danger of slipping behind. We mean this in several senses, including anticipating and keeping pace with clinical trial capacity needs, reaching consensus on standards of prevention and levels of care, and solidifying communications strategies for conveying information about trial outcomes. There are also open questions about the new US approach to funding its trial networks. In the spirit of thinking globally and acting locally, we’ve highlighted specific examples from work around the world as a way of emphasizing issues that affect all prevention research.

- HIV Prevention Roadmap

- Figure 11. Countries with AIDS Vaccine Trials (August 2007)

- Table 4. Trials of New Prevention Options Worldwide

- Table 5. Trials of Preventive HIV/AIDS Vaccine Worldwide (August 2007)

Section 3: Wake Up Call
In this section we explore the critical lessons to be learned from responses to data on new approaches which could have some benefit in out-of-control epidemics. The clock is already running when it comes to implementing existing prevention approaches like male and female condoms, as well as emerging prevention strategies like male circumcision. HPV vaccine, while not an HIV prevention tool, is still an important case study. We also listen hard to what advocates from other areas of the AIDS response have to say about prevention research—since collective action is essential for improved prevention overall.

- Figure 12. Coverage of Essential Prevention Services
- Figure 13. HIV Prevention Research: A Comprehensive Timeline of Efficacy Trials

2006 AVAC Report AIDS Vaccines: The Next Frontiers

In this year's AVAC Report, AVAC offers its first contribution to the scenario planning that we think is critical to the success of the field. The next several years will bring a variety of scenarios which we cannot encounter unprepared. Instead, the AIDS vaccine field, and the field of prevention research in general, must engage in rigorous debate, dialogue and scenario planning which anticipates the issues that the next few years will bring, and ensures that the wide range of stakeholders are informed and empowered to make decisions to compete against the virus. In this report, we present four thought-provoking chapters, each of which begins with a future scenario that considers how the world might look in five or six or ten years' time.

For a printed copy of the 2006 AVAC Report please email your request to avacreport@avac.org.

AIDS Vaccines: The Next Frontiers full PDF

Executive Summary

Table of Contents

Letter from the Board President and Executive Director

	01 AIDS Vaccine Science, Strategy and Action: The state of the field, the stakes for the future   This chapter provides an update on the state of AIDS vaccine science and science management, including an analysis of the Global HIV Vaccine Enterprise and its ongoing search for an executive director; and of the new Enterprise-related funding streams which emerged in 2005-2006.   Box 2: Update on the Global HIV Vaccine Enterprise Figure 1: Understanding the Cosmology of the Global HIV Vaccine Enterprise Table 2: Trials of Preventive HIV/AIDS Vaccines Worldwide
	02 Reports from the Frontlines: Learning from last year's clinical trials   This chapter analyzes successes and new challenges in the conduct of AIDS prevention clinical trials and concludes that a consensus on “good community practice” is needed. Look for an upcoming draft set of “GCP” guidelines that could help the scientific community and communities in the field ensure that every trial that is initiated meets agreed-upon criteria for substantive and sustainable engagement with the issues.   Box 5: What Would Make Multi-Functional Sites a Reality? Perspectives from South Africa
	03 The Emerging Adolescent Agenda: HPV vaccine, AIDS prevention research, and the new opportunities for reaching the young people of the world   This chapter explores why licensure of the vaccine against human papillomavirus (HPV) presents the AIDS vaccine field with new opportunities. AVAC calls on the field to advocate for financing commitments to ensure widespread access to the vaccine; document and learn from HPV experiences with trials and pilot programs among adolescents; and collaborate on advocacy and communication campaigns at every level.   Table 3: HPV Vaccine and HIV Vaccines: How Do They Compare?
	04 AIDS Prevention Evolves (Again): Why we are on the verge of an era of new complexity?   This chapter outlines why the next few years will bring developments that make AIDS vaccine research more complicated—though no less necessary.   Table 4:Trials of New Prevention Options Worldwide Figure 6: Research That Could Redefine Prevention: Timeline of Anticipated Results

2005 AVAC Report: AIDS Vaccines at the Crossroads

In the 2005 Report, AIDS Vaccines at the Crossroads, we lay out what we see as some of the major challenge areas we all will face and offer recommendations for navigating them.

We offer recommendations for the field in general, the Global HIV Vaccine Enterprise, policy makers, researchers and communities. Some of these recommendations will be familiar because we've made them before, and we reiterate them because we believe they are still needed and useful. (See our timeline of 10 years of AVAC recommendations for a perspective on progress over the past decade.) We also provide an update on tenofovir pre-exposure prophylaxis research.

And some analysis and recommendations are new. For example, we take an in-depth look at intellectual property issues and offer some "small step" recommendations that we believe will help move the field forward.

- For the Exec Summary on-line
- For the Exec Summary PDF - English, Français, Español, ไทย

- For the full PDF
- For a list of recommendations in this Report PDF...
- For "The Past Year: Update, Analysis and Recommendations"
- For "Ten years and counting: A decade of AVAC recommendations"
- For "Get Enterprising: an open letter to the soon-to-be-named executive director of the Global HIV Vaccine Enterprise"
- For "Follow the money: Money, development and research"
- For a legislative update
- For "Intellectual property at the crossroads"
- For "Don't shoot the messenger: An update on tenofovir research"
- For "Advocates' work is never done"

2004 AVAC Report: AIDS Vaccine Trials - Getting the Global House in Order

The Report focuses on how the field is readying itself for the road ahead. Several chapters address different aspects of "readiness" - a term that means different things to different people, but that is at the heart of the AIDS vaccine advocacy agenda today.

The Report chapters include:
- Milestone update on vaccine research and development
- Getting the global house in order
- The correlates of readiness
- How vaccine trials can and should leave communities better off
- Adolescents: the missing cohort
- Invoking the Enterprise

If you would like to receive a hard copy of this publication you may email your request to avac@avac.org or call 212-367-1021. You may also download a version using Adobe Acrobat 4.0 or greater by using the link provided below.

2004 AVAC Report
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4 Years and Counting: 2003
How Do You Fight a Disease of Mass Destruction?

When America became frightened by the bio-terror threat, Congress and the Administration moved swiftly to put funding and incentives in place. That same kind of decisive action is needed to accelerate research and ensure an AIDS vaccine is available to all who need it. This year's report looks at the bioterror model, and provides the results of our new industry survey.

The report also includes a series of articles on particular subjects that raise important questions. Chapters include:

• What can the federal response to bioterror teach us about finding an AIDS vaccine?
• Show us more than the money: our new legislative agenda
• The AVAC Fund makes its first awards
• The sorry fate of vaccine development milestones
• Are there too many "me-too" products in the pipeline?
• Are they getting it right at VRC?
• The VEE delay: what are the lessons for future collaboration?

4 Years Report, Online Version in PDF



5 Years and Counting: 2002
Science, Urgency, and Courage

Five years away from the date former President Bill Clinton set as a goal for finding an AIDS vaccine there are more candidate vaccine products in development than ever before. No one knows if any of the current experimental vaccines will work. No one even knows for sure what immune response a vaccine needs to elicit to prevent HIV disease. The only way to obtain answers is to ask tens of thousands of altruistic and courageous volunteers to participate in dozens of trials. The only way to obtain answers is to invest hundreds of millions of dollars to fund these trials.

This year's report focuses on the importance of clinical research in advancing the science on AIDS vaccines. Chapters include:

• Clinical trials at the five-year mark: climbing heartbreak hill
• Community call to action
• Vaccines on a global scale
• U.S. government
• Vaccines as intellectual property
• New roles for state governments in the U.S.

5 Years Report, Online Version in PDF



6 Years and Counting: 2001
Can a Shifting Landscape Accelerate an AIDS Vaccine?

For a copy of Last Year's Report: "6 Years and Counting...Can a Shifting Landscape Accelerate an AIDS Vaccine?", please contact us at avac@avac.org or visit the link provided below.

6 Years Report, Online Version in PDF






7 Years and Counting: 2000
How Can We Overcome Obstacles to an AIDS Vaccine?

For a copy of "7 Years and Counting...How Can We Overcome Obstacles to an AIDS Vaccine?", please contact us at avac@avac.org or visit the link provided below.

7 Years Report, Online Version in PDF






8 Years and Counting: 1999
What Will Speed the Development of an AIDS Vaccine?

For a copy of "8 Years and Counting...What Will Speed the Development of an AIDS Vaccine?", please contact us at avac@avac.org or visit the link provided below.

8 Years Report, Online Version in PDF






9 Years and Counting: 1998
Will We Have an HIV Vaccine by 2007?

For a copy of "9 Years and Counting...Will We Have an HIV Vaccine by 2007?", please contact us at avac@avac.org or visit the link provided below.

9 Years Report, Online Version in PDF


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