Leadership BiosSteven Self, PhD
Executive Director of Statistical Center for HIV/AIDS Research & Prevention (SCHARP)
The HIV epidemic continues to grow worldwide despite major advances in understanding the pathogenesis of HIV infection and in our ability to treat the disease. Control of the epidemic requires improved methods and strategies for preventing HIV infection. An HIV vaccine that is simple to administer, inexpensive and that induces long-lasting immunity to all known HIV strains would be the optimal preventive measure. The thorough and efficient clinical evaluation of HIV vaccine candidates presents many scientific and operational challenges. There are multiple mechanisms through which an HIV vaccine might be effective and clinical trials must be designed to assess each potential mechanism; there are significant global heterogeneities in human and viral populations for which an HIV vaccine is needed and a program of clinical trials must be designed to assess the impact of these heterogeneities on vaccine effectiveness; the most appropriate settings for clinical evaluation of HIV vaccines are ones which typically lack existing infrastructure to support rigorous clinical research so that such infrastructure must be developed as part of the clinical evaluation program.
The focus of my research is: 1) the design, coordination and analysis of a clinical trials program to evaluate promising candidate HIV vaccines and 2) the development of new statistical study designs and analytic techniques that will increase the efficiency of those evaluations. The coordination of field trials is performed largely through activities of the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) for which I serve as Executive Director. SCHARP is composed of statistical coordinating centers for international NIH-funded clinical research networks including the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the Center for HIV/AIDS Vaccine Immunology (CHAVI) and the Microbicide Trials Network (MTN). SCHARP is located within the Vaccine and Infectious Disease Division (VIDD) for which I serve as Co-Director. Within VIDD, there are research groups working on modeling inter-host and intra-host dynamics of a variety of infectious agents including HIV, HSV-2 and influenza as well as the development of new statistical methods useful for vaccine research and development such as adaptive trial designs for vaccine evaluation, sieve analyses and the discovery and validation of immune correlates of vaccine-induced protection.
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