4
Clinical Trials Capacity
The Challenge: Three phases of clinical trials in humans are required to fully test a vaccine candidate. These trials must be conducted in the populations that would eventually use the vaccine. For HIV, this means conducting trials both in industrialized and developing countries (95% of new HIV infections occur in developing countries).
The Enterprise scientific strategic plan proposes the development of a network of training centers in developing countries to provide technical assistance in the following areas:
Recommendations: The Enterprise scientific plan calls for creating a network of vaccine manufacturing experts to engineer improved HIV vaccine production processes; these experts would be closely linked to vaccine discovery consortia and clinical trial sites. Such an effort will be particularly important as more HIV vaccine candidates are discovered and advance through clinical trials. Private industry involvement in such a network is critical, because most vaccine manufacturing expertise resides in the private sector.
- Enhancing research infrastructure, including trial sites and laboratories
- Training and supporting qualified staff
- Educating the public about vaccine trials to help with recruitment of informed study participants
- Ensuring coordination with the medical systems that provide care to people in communities where trials will take place
- Developing HIV vaccine trial sites that can also be used to test other new HIV prevention technologies, such as anti-HIV microbicides, as well as other biomedical interventions relevant to the host communities
