Nature Medicine
September 2010, Volume 16 No 9
http://www.nature.com/nm/index.html

Commentary
The 2010 scientific strategic plan of the Global HIV Vaccine Enterprise
The Council of the Global HIV Vaccine Enterprise: Seth Berkley, Kenneth Bertram, Jean-François Delfraissy, Ruxandra Draghia-Akli, Anthony Fauci, Cynthia Hallenbeck,
Madame Jeannette Kagame, Peter Kim, Daisy Mafubelu, Malegapuru W Makgoba, Peter Piot, Mark Walport, Mitchell Warren & Tadataka Yamada; for Members of the Enterprise: José Esparza, Catherine Hankins, Margaret I Johnston, Yves Lévy & Manuel Romaris; for Alternate members: Rafi Ahmed & Alan Bernstein

[Selected excerpts from the full Commentary]

The 2010 Plan’s two scientific priorities
Recognizing the importance of pursuing a diverse range of vaccine concepts and approaches, the 2010 Plan prioritizes two main drivers key to the next phase of HIV vaccine research and development that specifically require global collaboration.

First, the Plan recognizes that clinical trials and human clinical investigation present an unequalled opportunity to obtain important information about the human immune system and its response to vaccine candidates and that they are pivotal to advancing both vaccine discovery and vaccine development. Human efficacy trials are essential to defining the ability of vaccines to prevent infection or disease and for the discovery of vaccine-induced correlates and signatures of protection, which would ultimately accelerate the development or improvement of HIV vaccines for future licensure and public health use. This scientific imperative—made possible by major advances in laboratory and computational techniques that have opened up complex biological systems, including the human immune system, to rigorous and rapid scientific analysis—underpins the importance of clinical efficacy trials to advancing vaccine discovery and development.

Second, the Plan recognizes that trials must be linked to and build upon the tools and concepts of basic biomedical science, including genomics and computational biology, immunology, virology and model systems, to optimize both vaccine design and information on vaccine biology in humans. A strengthened clinical trials effort must therefore be accompanied by sustained, strong support for fundamental vaccine discovery research. In pursuing an increasingly science-driven clinical trials effort, the field will advance promising candidates toward vaccine licensure and, at the same time, contribute fundamental scientific insights that will improve future vaccine design, product development and clinical trials.

The 2010 Plan is therefore predicated on a multidisciplinary approach that bridges the lab and the clinic, entrenching human research as intrinsic to the discovery process, and mobilizing the collaborative efforts of basic, preclinical and clinical scientists in highly iterative vaccine design and testing…

Conclusion and next steps
The creation of the Global HIV Vaccine Enterprise and its emphasis on a shared Scientific Strategic Plan represents an unprecedented response by the international scientific community to the scientific, public health and humanitarian challenges posed by HIV/AIDS. Enterprise stakeholders have a shared commitment to fulfill three essential functions: conducting regular assessments of scientific priorities and updating them to reflect lessons learned, new opportunities and the influence of new scientific findings and new technologies, establishing global processes to address priority areas and establishing a culture of mutual accountability for effective implementation of the Plan by funders and investigators. These commitments remain imperative to the fulfillment of the 2010 Plan in driving progress in the field.

Over the past 18 months, major scientific advances have signaled the beginning of an important new phase in HIV vaccine research. At the same time, there is increasing evidence that the epidemic is in danger of spinning out of control. It is our collective responsibility to ensure that this moment is not lost. Continued progress in the field urgently requires that funders, aid agencies, researchers, industry, regulatory agencies, advocates and civil society commit to working together as an open and collaborative global community. Until a deployable, efficacious vaccine is developed, that objective will be the only and ultimate goal of the Global HIV Vaccine Enterprise.