YEAR
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RECOMMENDATIONS
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OUTCOMES and EVENTS
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1996
Industry Investment in HIV Vaccine Research
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To fully engage private sector resources in the effort to develop an HIV vaccine:
- Increase government funding for HIV vaccine research
- Target scientific research to stimulate industry investment.
- Expand commitment by large pharmaceutical companies.
- Increase commitment by affected communities.
- Expand public leadership.
The US President should make development of a safe, effective and inexpensive vaccine by 2007 a national priority.
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UNAIDS and IAVI are formed.
Early-phase AIDS vaccine trials have already been conducted in US by NIH through it AIDS Vaccine Evaluation Group, by Walter Reed Army Institute with Thai government, and by US and European pharmaceutical and biotech companies in US, Europe, Thailand, Brazil and China.
NIH AIDS review (Levine Report) identifies vaccine-related research as a highest priority and recommends formation of an external HIV vaccine oversight board.
AVAC interviews 23 companies with active or once-active HIV vaccine programs and makes five key recommendations shown here.
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1997
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President Clinton calls for a commitment to develop an AIDS vaccine within the next decade (on May 18, which becomes HIV Vaccine Awareness Day in subsequent years). G8 summit leaders call for an AIDS vaccine.
New vaccine research awards by IAVI and amFAR.
NIH forms AIDS Vaccine Research Committee, chaired by David Baltimore. Innovation Grants for HIV vaccine development program is initiated at its request. (Some years later, this committee is redefined as a working group.)
AVAC holds National AIDS Vaccine Advocates Forum in San Diego.
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1998
Will We Have an HIV Vaccine by 2007?
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At the current level of effort, we will not have an HIV vaccine in nine years. Unless more is done, the President's challenge will not be met:
Agencies funded to conduct HIV vaccine research and development must establish clearer plans and goals to expand the HIV vaccine pipeline.
The US government must be clear about who should take responsibility and accountability to achieve these goals.
Increased commitment, funding and courage is required from all sectors.
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UNAIDS and IAVI are formed.
IAVI initiates its first development partnerships, obtaining IP rights for international access.
There are 9 products in Phase I testing,
5 in Phase II. VaxGen, with private financing, opens first Phase III efficacy trial in US, Canada, and the Netherlands, that is followed by a 2nd trial in Thailand; these trials ultimately enroll nearly 8000 volunteers.
NIH revamps and expands initiatives in the areas between basic research and preclinical development.
Existing NIH vaccine evaluation (Phase I-II) and efficacy trials/preparedness programs are reconfigured into Vaccine Trials Network and Prevention Trials Network.
AVAC countdown begins.
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1999
What Will Speed Development of an AIDS Vaccine?
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US Government must request adequate funding increases, coordinate efforts, and set and adhere to interim goals.
Expand the UNAIDS effort.
Private industry must invest in a big way and leverage its private investment.
Not-for-profits and community organizations must mobilize support for research and industry involvement, unite and organize, institutionalize CAB and community involvement and work for access.
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South African AIDS Vaccine Initiative (SAAVI) is formed. First African AIDS vaccine trial begins in Uganda.
All major vaccine companies appear to be working on HIV vaccines.
Rep. Pelosi and Sen. Kerry introduce Lifesaving Vaccine Technology Act, first legislation to propose incentives for vaccines for AIDS, TB, and malaria, but Congress takes no action.
1st HIV Vaccine Handbook published by AVAC.
AVAC formally requests that NIH set mile-stones for vaccine development, suggesting six areas for tracking.
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2000
How Can We Overcome Obstacles to an AIDS Vaccine?
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Expand government programs as rapidly as they can effectively handle expansion.
Pass legislation that provides incentives for private sector involvement in HIV vaccine research - both "pushes" and "pulls" are needed because purposeful company activity is crucial.
Fund public outreach, education and communication programs.
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AIDS is finally understood to be a social, economic and security threat.
UNAIDS publishes its guidance on ethical considerations in HIV preventive vaccine research.
WHO/UNAIDS African AIDS Vaccine Program (AAVP) is formed.
EU pledges new funds for HIV vaccines. Bill & Melinda Gates Foundation grants $100 million to IAVI.
The public-private partnership, Canadian network for Vaccines and Immunotherapeutics (CANVAC) is formed.
Growing importance of international research, with active clinical trials and trials planned in 13 countries by 7 groups.
The Dale and Betty Bumpers Vaccine Research Center (VRC) is opened and Gary Nabel is named Director.
NIAID agrees to set annual milestones for products it supports and for funding initiatives.
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2001
Can a Shifting Landscape Accelerate an AIDS Vaccine?
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AVAC proposes a new vision for vaccine development:
- Gaps in research are filled.
- The public is engaged.
- Enlightened self-interest reigns.
- Every avenue is pursued.
- Leadership is ongoing.
- Lives in the developing world matter.
- Taking risk is rewarded.
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About 15 new products are poised to begin clinical trials. IAVI DNA+MVA enters trials in Kenya. Merck and NIAID agree to collaborate on DNA and Ad5 vaccine trials.
HVTN drop plans for Phase III study of ALVAC +gp120. Thai/Walter Reed trial goes forward.
AVAC identifies FDA and patent issues as critical to vaccine development and has first meetings with FDA.
Two books on HIV vaccines are published, Big Shot (P .Thomas) and Shots in the Dark (J. Cohen).
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2002
Science, Urgency, and Courage
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AVAC issues a community call to action, asking individuals, communities and organizations to incorporate advocacy for AIDS vaccines into your work and your life:
- Protecting trial participants.
- Accelerating ethical research.
- Involving and educating communities.
- Ensuring global vaccine access.
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US Congress passes legislation to stimulate research and investment, accelerate regulatory processes, accept liability, and create adequate purchase capacity for bioterror vaccines.
Department of Defense HIV research program transferred to NIH.
The European Union and member states create EuroVacc, the European Vaccine Effort against HIV/AIDS.
EuroVacc and CANVAC develop collaborative networks.
AVAC's legal advisors identify over 1000 issued patents in 13 selected HIV vaccine component categories.
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2003
How Do You Fight a Disease of Mass Destruction?
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A more systematic, integrated AIDS vaccine effort is needed to:
- Ensure products are not unnecessarily delayed en route to human trials.
- Fully utilize advances in standardization of assays and validation procedures while retaining flexibility to develop and use new assays.
- Serve the multiple needs common among vaccine producers: access to non-human primates, development of isolates and reagents and prepared clinical sites.
- Meet international standards for multi-site trials, provision of treatment and community involvement.
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Science magazine publishes call for Global HIV Vaccine Enterprise.
VaxGen results show Phase III trials are feasible, though reporting of results and results them-selves are disappointments.
First HIV vaccine trials in South Africa begin after long delays.
AVAC analyzes NIH, IAVI, and WRAIR mile-stones. Altogether only 10 products entered Phase I and only 3 entered Phase II in 3 years since 2000. In analysis of "me-too" products in clinical trials, 52% are DNA and/or MVA, 29% are ALVAC variations, and only 19% test other approaches.
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2004
AIDS Vaccine Trials - Getting the Global House in Order
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Well-designed clinical trials are a necessity:
- Clinical trials cannot be confined to the industrialized world.
- Trial infrastructure must be created.
- Efficacy trials cannot be done overnight.
- Clinical trials are just one element of the vaccine development process.
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G8 endorses the Enterprise, and over 100 scientists collaborate on its mission and initial scientific plan in six critical areas.
12 new products enter Phase I clinical trials. VaxGen Thai trial shows no efficacy.
IAVI is developing six international trial sites.
PAVE partnership of US government agencies plus IAVI is announced.
AVAC defines 14 correlates of readiness for international vaccine trials, identifies adolescents as "the missing cohort," and describes 8 ways vaccine trials can leave communities better off.
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2005
AIDS Vaccine at the Crossroads
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Scientists must follow an evidence-based agenda and work to achieve antibody, mucosal and innate immune responses.
The Enterprise and other collaborators must address knowledge sharing, intellectual property, regulatory and access issues.
Funders must improve incentives and support to bring talented young scientists into the field.
Trial hosts and sponsors must engage civil society more fully and integrate local prevention, testing and treatment with trials.
Leaders must implement strategies speedily with foresight and accountability.
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Enterprise publishes its scientific plan in Public Library of Science and convenes its first stakeholders' and funders' fora.
NIH and Gates Foundation commit up to $900 million of new money for Enterprise-related initiatives. CANVAC loses its government funding.
First proof of concept efficacy trial begins Ad5 vaccine in Western Hemisphere and Australia, by Merck and HVTN. IAVI opens first HIV vaccine trial in India. Large canarypox/gp120 efficacy trial in Thailand nears full enrollment.
Peer review of multipurpose international and domestic clinical trial sites and networks by NIH.
AVAC publishes 2nd AIDS Vaccine Handbook, focused on global perspectives.
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2006
AIDS Vaccines:
The Next Frontiers
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We must map out the pathway for the future to ensure that there is sufficient clinical trials capacity, human resource development and community and political will for the "long haul".
The AIDS vaccine field must collaborate with and learn from other fields, as HPV licensure and rollout provides valuable lessons on issues of trial participation, access, delivery and funding for a vaccine targeted at a population which will also need an AIDS vaccine - young people.
The AIDS vaccine field must prepare for an era of "platinum" prevention. The field must learn from last year's clinical trials as there are more reports and discussions on what works and what doesn't, the need to build clinical trials capacity and to ensure that communities are authentic partners in the research process. |
AVAC launches AIDS Vaccine Clearinghouse (www.aidsvaccineclearinghouse.org)
Merck's HPV vaccine Gardasil is approved by the FDA. HIV vaccine researchers have opportunity to collaborate on issues of adolescent vaccine trials and licensure as well as vaccine roll out issues in developed and developing countries.
Gates Foundation announces $287 million in new grants for HIV vaccine research in line with Enterprise Scientific Strategic Plan.
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