Brussels, 24 Jan 2005
The Global HIV/AIDS Vaccine Enterprise, whose membership includes the European Commission and the European and Developing Countries Clinical Trials Partnership (EDCTP), has outlined a strategic plan for developing an effective HIV vaccine.
The plan has been developed through a process of consultation involving 140 participants from 17 countries, plus the European Commission. It summarises the major roadblocks to developing an HIV vaccine, outlines the current scientific priorities, and elaborates an initial strategic approach to address these priorities.
Outlining its strategic plan in the Public Library of Science's 'Medicine' journal, the coordinating committee for the enterprise stresses that developing an HIV vaccine 'requires an effort of a magnitude, intensity and design without precedent in biomedical research.' Such a global enterprise can augment the efforts of individual teams of researchers, and promote a global and open community of problem solvers.
According to the strategic plan, scientifically, the most immediate goal is the development of new HIV candidate vaccines based on recently transmitted viruses, which offer the best hope of providing immune responses to those strains of the disease currently in circulation.
After analysing which avenues of research currently offer the best hope for developing vaccine candidates, the plan then turns its attention to less scientific strategic requirements. The first such example is the need to increase product development and manufacturing capacity.
'As more HIV candidate vaccines enter the pipeline, current capacity will be rapidly exhausted. The initial priority is to identify or establish one or more dedicated HIV vaccine bioprocess and analytical development groups that bring together the skill set and capacity to manufacture different promising candidates for clinical trials,' states the plan.
As well as increasing production capacity, the Vaccine Enterprise would also like to increase global capacity for conducting large-scale clinical trials, particularly in developing countries. This will be achieved through: increasing the quantity and quality of research staff, establishing sustainable research facilities to support trials, and expanding access to large, well-defined populations of uninfected people at high risk of HIV infection.
While Vaccine Enterprise accepts that intellectual property issues may arise at some point in the vaccine development process, they note that 'at present the top priority is to stimulate early stage research and vaccine design by increasing scientific freedom to operate, and sharing of data and biological materials.' Further consideration should be given to minimising restrictions on freedom of operation, sharing information, materials, expertise and trade secrets, and maximising access to essential technologies and inventions, it adds.
In terms of the research structures that will be needed in order to carry out the work, the Enterprise identifies several distinct formations tailored to a specific research challenge. First, networks of focused consortia and real or virtual centres will be ideally suited to address many of the current scientific roadblocks. Second, a global system of laboratories will work together to ensure the quality and standardisation of clinical research to enable comparison of data from different trials.
To ensure the development of quality trial sites, a network of collaborative Clinical Research Training Centres will be established, having a positive impact on the search for an HIV vaccine, as well on activities generic to clinical trials for other diseases. Finally, to ensure sufficient capacity in the development and manufacture of vaccine candidates, a network of individuals and companies with manufacturing experience will link to consortia involved in vaccine research.
In conclusion, the strategic plan calls for a doubling of the global expenditure on HIV vaccine research, currently at around 500 million euro per year. 'The Enterprise Coordinating Committee will analyse the additional financial requirements to fully implement the scientific plan [...] and explore options to leverage these funds from the public and private sector.' To consult the Enterprise's scientific strategic plan, please: click here