History of the Scientific Strategic Plan
The Global HIV Vaccine Enterprise emerged from a consensus paper signed by two-dozen researchers, funders and advocates published in the journal Science. Two years later, the Enterprise's Scientific Strategic Plan for accelerating HIV vaccine research was published in the February 2005 issue of Public Library of Science (PLoS) — Medicine. The plan described the major challenges facing the field and made recommendations in six priority areas as noted below.
The 2005 Plan catalyzed major, new activities and funding commitments of a number of government and non-government organizations. It also led to the creation of new research structures and new ways of collaborating on a global scale.
The immediate goal is to design candidate vaccines that cause the immune system to produce protective responses from both of its major arms — cellular immunity and neutralizing antibodies.
The laboratory assays that researchers use to assess immune response may not be comparable, severely hampering decisions about which candidates to pursue for further testing.
Product Development and Manufacturing
Once researchers have identified a vaccine design that they believe is promising, a critical phase of vaccine research is developing a manufacturing process that yields consistent batches over time.
Clinical Trials Capacity
Three phases of clinical trials in humans are required to fully test a vaccine candidate.
National regulatory oversight of clinical trials is the cornerstone of safe and scientifically valid medical research.
Intellectual Property Issues
Researchers routinely seek patents and other intellectual property protections for their inventions.