Steven G. Self
Ph.D., University of Washington, Biostatistics, 1981.
M.S., California State University, Biology, 1977.
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 throughactivities of the Statistical Center for HIV/AIDS Research and Prevention (SCHARP). SCHARP is composed of statistical coordinating centers for international NIH-funded clinical research networks including the HIV Vaccine Trials Network (HVTN) and the HIVPrevention Trials Network (HPTN. I serve as Co-Director of SCHARP. There are also methodological research groups working on biomathematical modeling of HIV infection dynamics and development of new statistical methods within SCHARP. Topics of current methodologic research include the use of interacting branching processes to model the early events of HIV infection and the potential for vaccines to impact the course of infection by changes in the dynamics of these processes, the development of efficient designs of Phase I/II vaccine trials for optimization of vaccination regimens over dose, schedule and route of administration, the development of statistical methods for the analysis and interpretation of new assays for cellular immune response, the development of new statistical methods for the analysis of effects of human and viral heterogeneity on vaccine efficacy and the use of post-infection biomarker data to assess potential vaccine effects on disease progression and secondary transmission.
American Statistical Association Society for Clinical Trials
NCI Board of Scientific Counselors
1986-1991, Associate Professor, University of Washington, Department of Biostatistics
1986-1989, Associate Member, Fred Hutchinson Cancer Research Center, Public Health Sciences Division
1984-1986, Assistant Professor, University of Washington, Department of Biostatistics
1984-1986, Assistant Member, Fred Hutchinson Cancer Research Center, Public Health Sciences Division
1983, Visiting Scientist, Rothamsted Experimental Station, UK, Department of Statistics
1982, Assistant Professor of Oncology, Johns Hopkins University, School of Medicine, Oncology Center
1981-1984, Assistant Professor, Johns Hopkins University, Bloomberg School of Public Health, Department of Biostatistics
1980-1981, Statistical Research Associate, Fred Hutchinson Cancer Research Center
1979, Teaching Assistant, University of Washington
1977-1978, Research Assistant, Seattle Heart Watch
1975-1977, Teaching Assistant, California State University, Long Beach
1984-present, Adjunct Professor, Johns Hopkins University, Bloomberg School of Public Health, Department of Biostatistics
Vertical T cell immunodominance and epitope entropy determine HIV-1 escape.. The Journal of clinical investigation. 123(1):380-93.. 2013.
HIV Vaccine Trials Network: activities and achievements of the first decade and beyond.. Clinical investigation. 2(3):245-254.. 2012.
Optimization and qualification of an 8-color intracellular cytokine staining assay for quantifying T cell responses in rhesus macaques for pre-clinical vaccine studies.. Journal of immunological methods. 386(1-2):10-21.. 2012.
Comparing and combining data across multiple sources via integration of paired-sample data to correct for measurement error.. Statistics in medicine. 31(28):3748-59.. 2012.
Magnitude and Breadth of the Neutralizing Antibody Response in the RV144 and Vax003 HIV-1 Vaccine Efficacy Trials.. The Journal of infectious diseases. 206(3):431-41.. 2012.
Fragmentation of SIV-gag Vaccine Induces Broader T Cell Responses.. PloS one. 7(10):e48038.. 2012.
A Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens. Statistical Communications in Infectious Diseases. 3(1). 2012.
Hand, foot, and mouth disease in China: patterns of spread and transmissibility.. Epidemiology (Cambridge, Mass.). 22(6):781-92.. 2011.
HIV fragment gag vaccine induces broader T cell response in mice.. Vaccine. 29(14):2582-9.. 2011.
Genetic impact of vaccination on breakthrough HIV-1 sequences from the STEP trial.. Nature medicine. 17(3):366-71.. 2011.
Safety and Immunogenicity of the MRKAd5 gag HIV Type 1 Vaccine in a Worldwide Phase 1 Study of Healthy Adults.. AIDS research and human retroviruses. 27(5):557-567.. 2011.
Estimation of the initial viral growth rate and basic reproductive number during acute HIV-1 infection.. Journal of virology. 84(12):6096-102.. 2010.
Tiered categorization of a diverse panel of HIV-1 Env pseudoviruses for assessment of neutralizing antibodies.. Journal of virology. 84(3):1439-52.. 2010.
Magnitude and breadth of a nonprotective neutralizing antibody response in an efficacy trial of a candidate HIV-1 gp120 vaccine.. The Journal of infectious diseases. 202(4):595-605.. 2010.
Equivalence of ELISpot assays demonstrated between major HIV network laboratories.. PloS one. 5(12):e14330.. 2010.
Ontogeny of Toll-like receptor mediated cytokine responses of human blood mononuclear cells.. PloS one. 5(11):e15041.. 2010.
Factors associated with the development of cross-reactive neutralizing antibodies during human immunodeficiency virus type 1 infection.. Journal of virology. 83(2):757-69.. 2009.
Response to Andrew Dunning's comment on 'evaluating a surrogate endpoint at three levels, with application to vaccine development'.. Statistics in medicine. 28(4):716-9.. 2009.
Simultaneous Evaluation of the Magnitude and Breadth of a Left and Right Censored Multivariate Response, with Application to HIV Vaccine Development.. Statistics in biopharmaceutical research. 1(1):81-91.. 2009.
Neonatal innate TLR-mediated responses are distinct from those of adults.. Journal of immunology (Baltimore, Md. : 1950). 183(11):7150-60.. 2009.