Interview with Robert Hecht, Senior Vice President for Public Policy, International AIDS Vaccine Initiative (IAVI)
Policy Innovations: How did IAVI get its start?
Robert Hecht: In 1994 the AIDS epidemic was escalating, and although important advances in prevention had been made to lower future infections, the international community acknowledged that these efforts would not, in the long run, be sustainable or end the epidemic. Those working in the field understood that an AIDS vaccine would be the best long-term tool to blunt and ultimately end the epidemic, but minimal progress had been made to accelerate a vaccine’s development.
In response to this crisis, the Rockefeller Foundation convened an international meeting of scientists, public health officials and pharmaceutical industry and NGO leaders in Bellagio, Italy to evaluate the existing barriers to HIV/AIDS research. Concluding that there was a gap in existing vaccine development efforts—particularly in applied vaccine development and in coordinated international scientific activities and funding strategies—participants called for a new type of organization to accelerate the development of AIDS vaccines. A scientific meeting held in Paris later that year further assessed the impediments to vaccine progress and proposed a radically different approach to HIV vaccine development that would complement existing efforts.
These meetings became the impetus for the establishment of IAVI, in 1996, as an international NGO tasked with aggressively pursuing previously neglected approaches to AIDS vaccine development.
IAVI’s article in Innovations journal stated that your organization was the first biomedical product development public-private partnership. What does that mean for the development of an AIDS vaccine?
Product development public-private partnerships (PDPs), which unite the public sector’s commitment to international public goods for health with private industry’s unique expertise and orientation, play a critical role in advancing research and development for neglected diseases in poverty-stricken regions of the world. As one of the world’s first biomedical PDPs, IAVI has been bridging public- and private-sector interests, with a view toward resolving the scientific, financial and incentive barriers facing AIDS vaccines.
IAVI has been at the forefront of the PDP movement, increasing industry investment in the development of safe and effective HIV vaccines. In its first 10 years, IAVI has tested six new vaccine products, established major new clinical trial capacity in Africa and Asia, mobilized more than $660 million in new funding for vaccine research, and significantly increased awareness of and commitment to vaccines through its advocacy and communications initiatives. IAVI has also been used as a model for the creation of numerous other PDPs focusing on other needed health tools, such as malaria and TB vaccines and drugs, and microbicides for the prevention of HIV and other sexually transmitted infections.
What other innovations has IAVI developed?
IAVI is driven by three fundamental principles—speed, flexibility, and the ability to take informed risk—which have helped to advance the AIDS vaccine development field.
Among its many accomplishments, IAVI and its partners have developed the first AIDS vaccine candidate designed specifically for Africa, where the majority of new HIV infections occur, and initiated the first AIDS vaccine trials in several countries, including Germany, India, Kenya and Rwanda. IAVI was responsible for the development of the first HIV vaccine immunological lab to be accredited with new good clinical laboratory practice (GCLP), which has helped to transform the AIDS vaccine research landscape by standardizing procedures and protocols so that data gathered from multiple labs can be compared and evaluated consistently.
IAVI has also created the first AIDS vaccine policy research and advocacy program to help raise the political profile of HIV/AIDS and increase the attention of policy makers to the need for an AIDS vaccine appropriate for developing countries and made available simultaneously throughout the world. IAVI has been a leader in a number of areas of policy analysis and advocacy, including tracking global spending on AIDS vaccine R&D; using intellectual property provisions which ensure equitable access to a vaccine; assessing the impact of a vaccine at global and national levels; strengthening national regulatory systems for clinical trials; and assisting in the design of national AIDS vaccine plans in a number of countries.
Why has IAVI chosen to work towards finding a vaccine for the HIV/AIDS epidemic, as opposed to working towards making drugs for HIV more accessible and affordable to those already infected?
IAVI strongly supports expanded treatment for HIV infected persons. At the same time, more effective prevention—and hence a vaccine—is urgently needed to stem the tide of new infections and contain the costs of treatment.
Out of an estimated 39.5 million people living with HIV worldwide by the end of 2006, 4.3 million were newly infected last year, according to the latest figures from UNAIDS. The AIDS epidemic continues to outpace the world’s response. As we do everything possible to treat and care for those who are currently infected, we must simultaneously pursue the development of new prevention tools, such as vaccines, that hold the most promise to halt the spread of AIDS worldwide.
With nearly 12,000 persons becoming newly infected with HIV each day, accelerating the timetable towards a vaccine must be a global health and development priority. IAVI estimates that even a modestly effective AIDS vaccine could slash the number of new infections by one third over the course of a decade, saving tens of millions of lives.
What are some of the obstacles that IAVI has encountered and how has it dealt with them?
Despite significant progress and 37 ongoing clinical trials, the goal of a safe, effective and globally accessible preventive AIDS vaccine remains elusive. The development of any new vaccine is a long and complicated scientific research process. However, designing an AIDS vaccine poses a unique set of scientific challenges. Unlike many other epidemics for which successful vaccines have been developed, there are no known cases of HIV-infected individuals eliminating the virus completely from their bodies. Thus there is no clear roadmap on how to stimulate the immune system to "clear" HIV infection. Second, HIV does not usually elicit broadly-neutralizing antibodies, so the standard vaccinology strategy of mimicking natural infection to induce a neutralizing antibody response may not work against HIV. Third, HIV inserts copies of its genetic material into human cells within days of entering the human body to create a persistent yet immunologically invisible reservoir of infection. Finally, HIV is a moving target: its ability to evolve and mutate rapidly to escape immune responses, coupled with the enormous genetic diversity of the virus, pose monumental challenges to the development of an effective vaccine.
IAVI, along with the rest of the AIDS vaccine field, must also address importnt financial and political challenges. Despite recent increases in funding for AIDS vaccine R&D, there are significant shortfalls in support for rational vaccine design and strengthening clinical trials capacity. Large-scale efficacy trials of the most promising vaccine candidates will further increase costs in the coming years. Sustained and flexible funding is vital, since developing an AIDS vaccine will be a long-term undertaking and new priority activities will emerge as the field advances and we learn more through trial and error.
In addition, the large scientific and commercial risks associated with AIDS vaccines have tended to keep industry on the margins of the search. There needs to be greater engagement by the private sector, which holds much of the needed expertise—product development, bioengineering, manufacturing and commercialization—to create an AIDS vaccine.
What are some of the ethical dilemmas the organization encounters in conducting biomedical research throughout the world, and how are those dilemmas overcome?
Both vaccines and drugs are tested in stages, each taking a number of years, to ensure their safety and efficacy. IAVI adheres to the highest ethical standards and follows all national and international guidelines for its pre-clinical and clinical research. Before any trial can begin, an ethics committee must approve the protocol and make sure that it is in the interests of the people involved in the trial, and national regulatory authorities must assess the safety of the product and the soundness of the proposed study design.
One of main challenges faced by IAVI and other organizations conducting AIDS vaccine research is to make sure that volunteers fully understand and agree to the vaccine trial procedures and what is expected of them. To ensure that the rights of trial participants are protected, international ethics guidelines have been established for all pharmaceutical and vaccine trials. These guidelines are reinforced by an independent review system on a national and trial-site basis. All potential volunteers are educated about the trial and, after thorough discussion, must give their informed consent—a written agreement to participate in a trial based on the volunteer's complete understanding of all relevant information—should they wish to join the trial. Sponsors of clinical trials must demonstrate that they will employ only qualified research staff and will take all the steps needed to maximize the confidentiality of volunteers. Volunteers in an AIDS vaccine trial receive extensive risk-reduction counseling throughout the trial and access to prevention methods such as condoms. They may also receive medical care during the trial period for issues unrelated to the trial itself. In addition, a volunteer can decide to leave the study at any time without explanation.
What else has IAVI done to advance the fight against HIV/AIDS?
In addition to accelerating AIDS vaccine research and working to create a favorable policy environment that will speed the uptake of an eventual vaccine, IAVI works to educate and actively engage the communities hardest hit by the AIDS epidemic worldwide.
IAVI advocates for a comprehensive global response to HIV/AIDS that includes increasing access to current and future HIV/AIDS treatments and prevention products at the local and community level. In areas where vaccine trials are taking place, IAVI informs community members about the research process, as well as about current HIV prevention methods and treatment options. In addition, IAVI offers vaccine trial participants access to voluntary counseling and testing programs. IAVI works through a large number of partnerships and strives to close the “North-South” divide, taking the science and research of the North and applying it to the problems of the South, in collaboration with local researchers and political leaders.
IAVI also focuses on vulnerable groups such as women and youth, which are heavily affected by the AIDS epidemic. As the proportions of HIV-infected women continue to grow in many countries of Asia, Eastern Europe and Latin America, IAVI has incorporated gender-related issues in its vaccine trials and its advocacy initiatives, improving the participation of women in trials and promoting a range of future options to address the complex web of physiological and socioeconomic factors that increase women’s vulnerability to HIV infection.
What is IAVI’s most recent work in the search for a vaccine?
In the last two years, IAVI launched vaccine trials in India, Zambia, Rwanda, South Africa, Uganda and Kenya—the first AIDS vaccine trials in several of these countries. IAVI has also partnered with a number of other organizations to analyze how improved public policies could help to accelerate vaccine R&D and ensure global access to a future vaccine. IAVI has documented a wide range of key issues, including vaccine R&D expenditures, future spending needs, vaccine demand scenarios and the analysis of the potential impact of a vaccine in lowering the number of new HIV infections. IAVI has then built upon this policy analysis by promoting awareness about the need for an AIDS vaccine among political, community, financial and scientific leaders.
What’s in store for the future?
HIV is a difficult adversary, but scientists believe that an AIDS vaccine is possible. To date, there have been several milestones in AIDS vaccine development, marking progress in our understanding of the HIV virus and ways to design an effective vaccine against it, as well as in our ability to conduct efficient AIDS vaccine clinical trials in a wide variety of settings, including in developing countries badly affected by the AIDS pandemic. In addition, thanks to increased political and financial commitment over the past few years, new scientific consortia comprising leading HIV researchers are tackling crucial scientific questions.
Researchers know that the immune systems of some individuals have a natural ability to prevent infection with HIV. In other individuals, the immune system appears to control the progression of the disease. Experimental vaccines against SIV, a close cousin of HIV that infects monkeys, have been shown to prevent AIDS. Together, these findings support the scientific potential for a vaccine to prevent AIDS in humans.
There are two large-scale AIDS vaccine trials ongoing. One, involving 16,000 volunteers in Thailand, will have results in 2008-09. Another, with 6,000 volunteers in the United States, Latin America, the Caribbean and South Africa, will also provide major findings in the next two years. In the next 24-26 months, we will see whether the world is close to a vaccine that can help to slow the AIDS epidemic worldwide. In the meantime, more work is being done to improve the current vaccine concepts and to design and test novel approaches that can yield a vaccine of even higher efficacy and long-lasting duration.