A powerful international consortium set up to accelerate research into a vaccine against HIV/Aids has identified major barriers to the first generation of commercially available HIV vaccines — and ways to overcome these obstacles, says a Science and Development Network report.
The consortium, the Global HIV/Aids Vaccine Enterprise, has identified major roadblocks barring the first commercial HIV vaccines in research, human resources, product development and manufacturing, regulatory approval, and intellectual property.
The plan outlines an approach to overcoming each set of obstacles.
In this month’s issue of the Public Library of Science’s free open-access journal, PLoS Medicine, the group’s plans are detailed.
These include creating a network of clinical research training centres in developing countries such as South Africa. This ensures laboratories can develop, buy and store quality research chemicals.
Another goal is 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 such as those in Africa.
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 United States-based Aaron Diamond Aids Research Centre, in an accompanying article.
Ho is concerned, however, the enterprise’s “mission-oriented 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 Group of 8 industrialised countries in 2004. — SciDev.Net