The Council of the Global HIV Vaccine Enterprise on Tuesday released a new strategy for HIV vaccine research, which marked “the culmination of an 18-month effort that included the input of 400 scientists worldwide,” VOA News reports (DeCapua, 9/7).
The strategy, published as a Commentary (.pdf) in the journal Nature Medicine builds off the recommendations issued by the group in 2005 and “provides a forward-looking framework to speed the development, execution and analysis of HIV vaccine trials; better integrate pre-clinical 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,” according to a Global HIV Vaccine Enterprise press release (.pdf) (9/7).
“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,” the group writes in Nature Medicine.
“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. … 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,” they write (9/8).
MedPage Today examines the group’s appeal for “more and better human trials as part of the search for a way to prevent [HIV] transmission.” The news service continues, “We’ve always regarded trials as the icing on the cake, the culmination of a series of basic science experiments,” Global HIV Vaccine Enterprise Executive Director Alan Bernstein said. “But instead of simply testing a potential agent, as a way to bring it forward for regulatory approval, human trials should be designed to be ‘an integral part of the whole discovery process,’ Bernstein told MedPage Today in an interview.”
Such a push for “clinical trials is a sea change from early 2008, when the failure of a major vaccine candidate had some researchers suggesting that studies in humans should be abandoned,” MedPage Today writes. More clinical trials “will inevitably need more money, Bernstein told MedPage Today,” the news service writes. “Currently, HIV vaccine research costs about $850 million a year worldwide, but a large clinical trial can cost a substantial fraction of that.” The article notes the appeal by scientists to invest more funds for vaccine research (Smith, 9/7).
“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,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) said, according to the Global HIV Vaccine Enterprise press release.
Among several recommendations, the Scientific Strategic Plan calls for the field to strengthen or create new research structures “to bring together basic, preclinical and clinical researchers to design, execute and analyze trials; … develop a robust pipeline of diverse vaccine strategies; 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[;] … increase the engagement of the pharmaceutical and biotechnology industries in advancing vaccine research and development … [; and] expand and diversify funding for HIV vaccine research,” according to the press release (9/7).
VOA News includes additional comments by Bernstein, who addresses the need for researchers to work together with the pharmaceutical industry so as to develop an HIV vaccine as quickly as possible, and highlights recent progress in HIV vaccine development (9/7).
“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,” the authors of the Nature Medicine Commentary write.
“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,” they conclude (9/8).
Kaiser Daily Health