Speeding the Way to a Vaccine

A new vision to accelerate the search for an HIV vaccine, developed by the Council of the Global HIV Vaccine Enterprise with the participation of hundreds of scientists, policy makers, funders, and advocates worldwide, was published today in Nature Medicine.

The Scientific Strategic Plan of the Global HIV Vaccine Enterprise provides a forward-looking framework to speed the development, execution, and analysis of HIV vaccine trials; better integrate preclinical and clinical research; more effectively capitalize on scientific advances from other fields; and bring new researchers and new funders to the global effort to develop a safe and effective HIV vaccine.

The plan, the product of an 18-month collaborative process involving input from more than 400 researchers, policy makers, funders,and advocates worldwide, was developed by the Global HIV Vaccine Enterprise, an alliance of independent HIV vaccine research funding, policy, and advocacy organizations dedicated to accelerating the development of a preventive HIV vaccine.

The strategy released today is a full update of a Scientific Strategic Plan developed in 2005. That plan substantially reshaped the field, leading to the creation of new initiatives to address longstanding scientific and organizational obstacles in HIV vaccine research, and helping to promote many of the scientific advances that have brought the goal of a safe and effective HIV vaccine closer today.

The new Scientific Strategic Plan seeks to build rapidly on recent progress in the field by tackling the most significant barriers to HIV vaccine research. The plan is informed by detailed reports on specific challenges and opportunities in the field developed by five Working Groups created by the Enterprise Science Committee.

"We are at an important moment in the 27-year journey to develop an effective vaccine against HIV," said Alan Bernstein, Ph.D., executive director of the Global HIV Vaccine Enterprise. "Last year, the RV144 trial in Thailand provided the first evidence that a vaccine can prevent HIV acquisition. Recent discoveries such as the isolation of broadly neutralizing antibodies are informing new strategies for vaccine design, while powerful new technologies are significantly advancing our understanding of HIV infection and the human immune system. These scientific advances, coupled with a new spirit of global collaboration in HIV vaccine research and the ambitious roadmap provided by the Scientific Strategic Plan of the Enterprise, point to a new era of great progress in the search for an HIV vaccine."

"HIV/AIDS is a catastrophic global epidemic, and a vaccine is a top global health priority," said Peter Piot, MD, Ph.D., incoming director of the London School of Hygiene and Tropical Medicine and chair of the Global HIV Vaccine Enterprise. "With 33 million people living with HIV, 50,000 new infections each week and only two in five people in need receiving HIV treatment, the need for a vaccine that can help slow and one day end this epidemic has never been greater."

"There has been notable progress in the quest to identify an effective HIV vaccine. The new Enterprise Scientific Strategic Plan will further catalyze the collaborative research necessary to build on recent advances and bring a safe and effective HIV vaccine closer to reality," said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the U.S. National Institutes of Health.

The Scientific Strategic Plan provides a set of priorities and recommendations to build on the progress of the last five years. The Plan highlights the need to fundamentally alter how clinical trials are developed and implemented and recommends that the field: >strengthen existing research structures or create new ones that bring together basic, preclinical and clinical researchers to design, execute and analyze trials;

>explore novel trial design strategies and implement process improvements to significantly increase the number, efficiency and speed of clinical trials;

>develop a robust pipeline of diverse vaccine strategies;

>ensure the compatibility of trial data, regardless of sponsor;

>strengthen the global, ethical, legal and regulatory frameworks that guide and facilitate HIV vaccine research;

>maintain appropriate and flexible research capacity in high-incidence countries; and

>strengthen community engagement throughout trial design and implementation.

The plan also recommends a series of strategies to harness the full potential of significant recent advances in biomedical science through greater efforts to incorporate new tools and ideas from other areas of biomedical research. Among these are advanced imaging technologies to study mucosal immunity and genomic technologies to better understand host factors that regulate the immune response. The Plan calls for increased efforts to foster collaboration with researchers from disciplines that have the potential to transform current approaches to HIV vaccine discovery and development, such as systems biology, which provides a promising approach for the integrative analysis and modeling of large datasets.

The Scientific Strategic Plan also includes recommendations to:

>increase the engagement of the pharmaceutical and biotechnology industries in advancing vaccine research and development;

>strategies to attract and support the brightest minds to HIV vaccine research, including efforts to mentor young and early-career investigators from regions seriously affected by the epidemic;

>expand and diversify funding for HIV vaccine research. Currently, the vast majority of global HIV vaccine research support is provided by a handful of funders, with many wealthy nations and emerging economies and technological powers contributing little to the global effort.

"We need a rich diversity of global support in order to successfully develop an HIV vaccine and start writing the story of the end of AIDS," said Jose Esparza, senior adviser for HIV vaccines at the Bill & Melinda Gates Foundation. "From funding to building and supporting national research systems, many more countries and funders must become fully engaged in this effort."