The Global HIV/AIDS Vaccine Enterprise, an international consortium set up to accelerate research into a vaccine against HIV/AIDS, published its scientific strategic plan in this month's issue of PLoS Medicine.
The consortium has identified the major barriers to the first generation of commercially available HIV vaccines in a number of sectors. These include obstacles related to research, human resources, product development and manufacturing, regulatory approval, and intellectual property.
The strategic plan outlines an approach to overcoming each set of obstacles. The document then describes the group's scientific plans.
These include creating a network of clinical research training centres in developing countries, ensuring laboratories can develop, buy and store quality research chemicals, and developing a system for sharing information and research findings.
The plan's authors say the gap between existing capacity and future requirements for large clinical trials is particularly wide in developing nations.
They suggest three key steps to address this problem: increasing the number and quality of research staff, creating facilities to support trials, and improving access to uninfected, high-risk sections of local populations to participate in clinical trials.
The severe shortage of trained personnel in developing countries is a major obstacle to conducting clinical trials, says the plan.
It underlines the importance of expanding research-training opportunities in developing countries, while ensuring that staff have adequate long-term career paths, and that the social and political environments support clinical research.
"The scientific strategic plan of the enterprise is spot-on in identifying the major roadblocks in HIV vaccine development, as well as in establishing the key scientific priorities as we see them today," says David Ho, scientific director of the US-based Aaron Diamond AIDS Research Centre, in an accompanying article.
Ho is concerned, however, the enterprise's "mission-orientated approach" may ignore important findings that come from "curiosity-driven basic studies".
Virginia Barbour, Barbara Cohen and Gavin Yamey, senior editors of PLoS Medicine, also see a potential flaw in the enterprise's concerted approach. In their editorial, they ask whether it would not be healthy to encourage a certain amount of competition in order to drive research efforts.
"As long as it remains unclear where scientific breakthroughs will come from, diversity and flexibility should be encouraged and not stifled," they write.
But they believe the absence of a timeline for each task is the strategy's greatest shortcoming.
"The enterprise's plan should be hailed as a crucially important outline for vaccine development, but the goodwill surrounding it won't last unless it is quickly followed up with a set of milestones, and a transparent process by which progress will be measured and course corrections implemented," they conclude.
The Global HIV/AIDS Vaccine Enterprise is an international alliance of agencies and organisations that undertake or support HIV vaccine research. Its creation was proposed in 2003 by a group of international researchers, and was endorsed by the 'G8' group of industrialised countries in 2004.Link to the full article in PLoS Medicine
Link to the full article by David Ho in PLoS Medicine
Link to the full editorial by Virginia Barbour, Barbara Cohen and Gavin Yamey in PLoS Medicine