Curriculum Vitae. William C. Blackwelder, Ph.D. Head, Biostatistics Unit Professor, Department of Medicine

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1 Curriculum Vitae William C. Blackwelder, Ph.D. Head, Biostatistics Unit Professor, Department of Medicine Date April 29, 2016 Contact Information Business Address: University of Maryland, Baltimore Center for Vaccine Development 685 W. Baltimore St., HSF I, Room 480 Baltimore, MD Business Phone Number: (410) Fax: (410) Education A.B., Mathematics, Duke University 1966 M.S., Statistics, University of North Carolina 1977 Ph.D., Biostatistics, University of North Carolina Employment History Academic Appointments 2004-present Professor, Department of Medicine, University of Maryland School of Medicine Other Employment 1999-present Biostatistical Consultant, Self Employed Biostatistical Consultant, Biologics Consulting Group Special Expert, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases Chief, Biometry Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases Chief, Biometry Section, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases Statistician, Epidemiology and Biometry Section, National Institute of Allergy and Infectious Diseases Statistician, Biometrics Research Branch, National Heart, Lung and Blood Institute Computing Engineer, North American Rockwell Corporation 1965 Summer Mathematician, Tennessee Eastman Company 1

2 Professional Society Membership 1968-present Former Former General Member, American Statistical Association Biometric Society Society for Clinical Trials Honors and Awards 1964 Phi Beta Kappa 1989 USPHS Commendation Medal 1994 USPHS Outstanding Service Medal DHHS Secretary's Award for Distinguished Service (group award) USPHS Outstanding Unit Citation (group award) FDA Commissioner s Special Citation (group award) 2001 Fellow, American Statistical Association 2016 Fellow, Society for Clinical Trials Professional Activities Other Activities National Institute of Allergy and Infectious Diseases Clinical Review Subpanel Review of clinical trial proposals for the U.S. Agency for International Development and the National Vaccine Program. Refereeing for scientific journals, including Biometrics, Statistics in Medicine, Controlled Clinical Trials, and American Journal of Epidemiology. Presenting papers and chairing sessions at national and international scientific meetings. Board of Directors, Society for Clinical Trials Member of National Institute of Allergy and Infectious Diseases Equal Employment Opportunity Committee. Major Duties and Statistical Activities Direction of data analysis for the Global Enteric Multicenter Study (GEMS), an observational study of diarrhea in children under five years of age at seven sites in sub- Saharan Africa and South Asia. Supervision of post-doctoral fellow in biostatistics. Lecturing on statistical methods for PREV 803, a course in clinical trials in the Epidemiology and Preventive Medicine Department, School of Medicine, UMB. 2

3 Methodological Research Collaboration in phase 1 and 2 studies at CVD of various vaccines, e.g., vaccines against malaria, influenza, and shigellosis. Direction of Biometry Section and Biometry Branch, Division of Microbiology and Infectious Diseases, NIAID/NIH; supervision of statisticians, statistical assistants, and epidemiologist at the GS-05 to GS-14 levels. Innovative approaches to design and analysis of trials of clinical equivalence and vaccine efficacy. Work on the sampling and analysis of sibling data for genetic linkage analysis. Collaboration on design and analysis for acellular pertussis vaccine trials in Sweden and Italy; innovative work in determination of appropriate hypothesis and corresponding methods for sample size determination. Consultation on design and analysis of clinical trials in infectious diseases (vaccines and therapies), cancer, and sickle cell disease. Service on Data Monitoring Committees in infectious diseases and cancer; chair of National Institute of Allergy and Infectious Diseases Intramural Data and Safety Monitoring Committee Project Officer for data coordinating center contract and collaborator, Vaginal Infections and Prematurity (VIP) study, a multicenter study of 1) the association of genital infections in pregnant women with prematurity and 2) possible prevention of prematurity through antibiotic treatment. Development of method to calibrate radioimmunoassays of antibodies to pneumococcal antigens. Data analysis and reporting of results in the Multicenter AIDS Cohort Study. Collaboration on study of excess mortality due to influenza virus activity. Coordination of investigation of relation between herpes virus infections and histocompatibility (HLA) antigens in the Framingham Study cohort. Data analysis and preparation of reports from the Honolulu Heart Study, particularly on the relation between alcohol consumption and mortality. Construction of balanced incomplete block designs Comparison of methods for detecting familial aggregation Appropriate methodology for equivalence and similarity trials Sample size and power for testing a hypothesis on relative risk Interim monitoring when the number of events is small Design of vaccine efficacy trials, estimation of vaccine efficacy Evaluation of a reconstructed cohort approach to analysis of matched case-control data 3

4 Publications Peer-reviewed journal articles 1. Blackwelder WC. On constructing balanced incomplete block designs from association matrices with special reference to association schemes of two and three classes. Journal of Combinational Theory 7:15-36, Blackwelder WC. Construction of the BIB (36,36,15,15,6). Sankhya Series B 31: , Rogot E, Blackwelder WC. Associations of cardiovascular mortality with weather in Memphis, Tennessee. Public Health Reports 85:25-39, Krueger DE, Rogot E, Blackwelder WC, Reid DD. The predictive value of a postal questionnaire on cardiovascular symptoms. Journal of Chronic Diseases 23: , Halperin M, Blackwelder WC, Verter JI. Estimation of the multivariate logistic risk function: a comparison of the discriminant function and maximum likelihood approaches. Journal of Chronic Diseases 24: , Mason RG, Shermer RW, Zucker WH, Elston RC, Blackwelder WC. An in vitro test system for estimation of blood compatibility in biomaterials. Journal of Biomedical Materials Research 8: , Mason RG, Shinoda BA, Blackwelder WC, Elston RC. Blood compatibility of biomaterials: further evaluation of the Lindholm tests. Biomaterials, Medical Devices, Artificial Organs 2:21-30, Greenberg B, Blackwelder WC, Levy RI. Primary type V hyperlipoproteinemia: a descriptive study in 32 families. Annals of Internal Medicine 87: , Rhoads GG, Blackwelder WC, Stemmerman GN, Hayashi T, Kagan A. Coronary risk factors and autopsy findings in Japanese-American men. Laboratory Investigation 38: , Schaefer EJ, Anderson DW, Brewer HB, Levy RI, Danner R, Blackwelder WC. Plasmatriglycerides in regulation of H.D.L.-cholesterol levels. Lancet ii: , Yano K, Blackwelder WC, Kagan A, Rhoads GG, Cohen JB, Marmot M. Childhood cultural experience and the incidence of coronary heart disease in Japanese-American men in Hawaii. American Journal of Epidemiology 109: , Blackwelder WC, Yano K, Rhoads GG, Kagan A, Gordon T, Palesch Y. Alcohol and mortality: the Honolulu Heart Study. American Journal of Medicine 68: , Alling DW, Blackwelder WC, Stuart-Harris CH. A study of excess mortality during influenza epidemics in the United States, American Journal of Epidemiology 113:30-43, Blackwelder WC, Kagan A, Yano K, Rhoads GG. Comparison of methods for diagnosing angina pectoris: the Honolulu Heart Study. International Journal of Epidemiology 10: , Evans R and Committee on In Vitro Tests (member of committee). A U.S. reference for human 4

5 immunoglobulin E. Journal of Allergy and Clinical Immunology 68:79-82, Blackwelder WC, Elston RC. Power and robustness of sib-pair linkage tests and extension to larger sibships. Communications in Statistics-Theory and Methods 11: , Blackwelder WC, Dolin R, Mittal KK, McNamara PM, Payne FJ. A population study of herpes virus infections and HLA antigens. American Journal of Epidemiology 115: , Blackwelder WC, Alling DW, Stuart-Harris CH. Association of excess mortality from chronic nonspecific lung disease with epidemics of influenza. Comparison of experience in the United States and in England and Wales, American Review of Respiratory Disease 125: , Blackwelder WC, Mittal KK, McNamara PM, Payne FJ. Lack of association between HLA and age in an aging population. Tissue Antigens 20: , Blackwelder WC, Henderson DK (letter). Frequency of changing tubing on mechanical ventilators. New England Journal of Medicine 307:1276, Blackwelder WC. "Proving the null hypothesis" in clinical trials. Controlled Clinical Trials 3: , LaMontagne JR, Noble GR, Quinnan GV, Curlin GT, Blackwelder WC, Smith JI, Ennis FA, Bozeman FM. Summary of clinical trials of inactivated influenza vaccine Reviews of Infectious Diseases 5: , Blackwelder WC, Chang MA. Sample size graphs for "proving the null hypothesis". Controlled Clinical Trials 5:97-105, Blackwelder WC, Elston RC. A comparison of sib-pair linkage tests for disease susceptibility loci. Genetic Epidemiology 2:85-97, Halperin M, Abbott RD, Blackwelder WC, Jacobowitz R, Lan KKG, Verter JI, Wedel H. On the use of the logistic model in prospective studies. Statistics in Medicine 4: , Lipnick RN, Karsh J, Stahl NI, Blackwelder WC, Schiffman G, Klippel JH. Pneumococcal immunization in patients with systemic lupus erythematosus treated with immunosuppressives. Journal of Rheumatology 12: , Data Analysis Workshop Committee (Members: Elston RC, Evans RR, Blackwelder WC, Buncher CR, Elashoff JD, Johnson MF). Workshop 8: data analysis. In: Report of the American Academy of Allergy and Immunology Task Force on Guidelines for Clinical Investigation of Nonbronchodilator Antiasthmatic Drugs. Journal of Allergy and Clinical Immunology 78: , Henderson DK, Saah AJ, Zak BJ, Kaslow RA, Lane HC, Folks T, Blackwelder WC, Schmitt J, LaCamera DJ, Masur H, Fauci AS. Risk of nosocomial infection with human T-cell lymphotropic virus type III/lymphadenopathy-associated virus in a large cohort of intensively exposed health care workers. Annals of Internal Medicine 104: , Saah AJ, Neufeld R, Rodstein M, LaMontagne JR, Blackwelder WC, Gross P, Quinnan G, 5

6 Kaslow RA. Influenza vaccine and pneumonia mortality in a nursing home population. Archives of Internal Medicine 146: , Dismukes WE, Cloud G, Gallis HA, Kerkering TM, Medoff G, Craven PC, Kaplowitz LG, Fisher JF, Gregg CR, Bowles CA, Shadomy S, Stamm AN, Diasio RB, Kaufman L, Soong S, Blackwelder WC and the NIAID Mycoses Study Group. Treatment of cryptococcal meningitis with combination amphotericin B and flucytosine for four as compared with six weeks. New England Journal of Medicine 317: , Kaslow RA, Phair JP, Friedman HB, Lyter D, Solomon RE, Dudley J, Polk BF, Blackwelder WC. Infection with the human immunodeficiency virus: clinical manifestations and their relationship to immune deficiency. Annals of Internal Medicine 107: , Rao AK, Schapira M, Clements ML, Niewiarowski S, Budzynski AZ, Schmaier AH, Harpel PC, Blackwelder WC, Scherrer J-R, Sobel E, Colman RW. A prospective study of platelets and plasma proteolytic systems during the early stages of Rocky Mountain spotted fever. New England Journal of Medicine 318: , Kaslow RA, Blackwelder WC, Ostrow DG, Yerg D, Palenicek J, Coulson AH, Valdiserri RO for the Multicenter AIDS Cohort Study. No evidence for a role of alcohol or other psychoactive drugs in accelerating immunodeficiency in HIV-1-positive individuals. Journal of the American Medical Association 261: , Havlik RJ, Blackwelder WC, Kaslow R, Castelli W. Unlikely association between clinically apparent herpesvirus infection and coronary incidence at older ages: the Framingham Heart Study. Arteriosclerosis 9: , Ehrenkranz NJ, Blackwelder WC, Pfaff SJ, Poppe D, Yerg DE, Kaslow RA. Infections complicating low-risk cesarean sections in community hospitals: efficacy of antimicrobial prophylaxis. American Journal of Obstretics and Gynecology 162: , Blackwelder WC, Hastings BK, Lee MLF, Deloria MA. Value of a run-in period in a drug trial during pregnancy. Controlled Clinical Trials 11: , Carey JC, Blackwelder WC, Nugent RP, Matteson MA, Rao AV, Eschenbach DA, et al. Antepartum cultures for Ureaplasma urealyticum are not useful in predicting pregnancy outcome. American Journal of Obstetrics and Gynecology 164: , Blackwelder WC, Storsaeter J, Olin P, Hallander HO. Acellular pertussis vaccines: efficacy and evaluation of clinical case definitions. American Journal of Diseases in Children 145: , Storsaeter J, Blackwelder WC, Hallander HO. Pertussis antibodies, protection and vaccine efficacy after household exposure. American Journal of Diseases in Children 146: , Sogn DD, Evans R, Shepherd GM, Casale TB, Conden J, Greenberger PA, Kohler PF, Saxon A, Summers RJ, VanArsdel PP, Massicot JG, Blackwelder WC, Levine BB. Results of the National Institute of Allergy and Infectious Diseases collaborative clinical trial to test the predictive value of skin testing with major and minor penicillin derivatives in hospitalized adults. Archives of Internal Medicine 152: ,

7 41. Ellenberg SS, Myers MW, Blackwelder WC, Hoth DF. The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases. Statistics in Medicine 12: , Blackwelder WC. Sample size and power for prospective analysis of relative risk. Statistics in Medicine 12: , Trollfors B, Taranger J, Lagergård T, Lind L, Sundh V, Zackrisson G, Lowe CU, Blackwelder W, Robbins JR. A placebo-controlled trial of a pertussis-toxoid vaccine. New England Journal of Medicine 333: , Reizenstein E, Hallander H-O, Blackwelder WC, Kühn I, Lyungman M, Möllby R. Comparison of five calculation modes for antibody ELISA procedures using pertussis serology as a model. Journal of Immunological Methods 183: , Klebanoff MA, Regan JA, Rao AV, Nugent RP, Blackwelder WC, Eschenbach DA, Pastorek JG, Williams S, Gibbs RS, Carey JC. Outcome of the Vaginal Infections and Prematurity Study: results of a clinical trial of erythromycin among pregnant women colonized with group B streptococci. American Journal of Obstetrics and Gynecology 172: , Deloria MA, Blackwelder WC, Decker MD, Englund JA, Steinhoff MC, Pichichero ME, Rennels MB, Anderson EL, Edwards KM. Association of reactions following consecutive acellular or whole-cell pertussis vaccine immunizations. Pediatrics 96: , Greco D, Salmaso S, Mastrantonio P, Giuliano M, Tozzi AE, Anemona A, Ciofi degli Atti ML, Giammanco A, Panei P, Blackwelder WC, Klein DL, Wassilak SGF, and the Progetto Pertosse Working Group. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. New England Journal of Medicine 334: , Regan JA, Klebanoff MA, Nugent RP, Eschenbach DA, Blackwelder WC, Lou Y, Gibbs RS, Rettig PJ, Martin DH, Edelman R. Colonization with group B streptococci in pregnancy and adverse outcome. American Journal of Obstetrics and Gynecology 174: , Friedman HB, Saah AJ, Sherman ME, Busseniers AE, Blackwelder WC, Kaslow RA, Ghaffari AM, Daniel RW, Shah KV. Human papillomavirus, anal squamous intraepithelial, and human immunodeficiency virus in a cohort of gay men. Journal of Infectious Diseases 178: 45-52, McKenzie R, O Fallon A, Dale J, Demitrack M, Sharma G, Deloria M, Garcia-Borreguero D, Blackwelder W, Straus SE. Low-dose hydrocortisone for treatment of chronic fatigue syndrome: a randomized controlled trial. Journal of the American Medical Association 280: , McKenzie R, Reynolds JC, O Fallon A, Dale J, Deloria M, Blackwelder W, Straus SE. Decreased bone mineral density during low dose glucocorticoid administration in a randomized, placebo controlled trial. Journal of Rheumatology 27: , Pichichero ME, Edwards KM, Anderson EL, Rennels MB, Englund JA, Yerg DE, Blackwelder WC, Jansen DL, Meade BD. Safety and immunogenicity of six acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four- to six-year-old children. Pediatrics 105: e11 (electronic article), Santos GF, Deck RR, Donnelly J, Blackwelder W, Granoff DM. Importance of Complement 7

8 Source in Measuring Meningococcal Bactericidal Titers. Clinical and Diagnostic Laboratory Immunology 8: , Hoover DR, Blackwelder WC. Allocation of subjects to test null relative risks smaller than one. Statistics in Medicine 20: , Simonsen L, Morens DM, Elixhauser A, Gerber M, VanRaden M, Blackwelder WC. Effect of rotavirus vaccination programme on trends in admission of infants to hospital for intussusception. The Lancet 358: , Nam J, Blackwelder WC. Analysis of the ratio of marginal probabilities in a matched-pair setting. Statistics in Medicine 21: , Miller KD, Masur H, Jones EC, Joe GO, Rick ME, Kelly GG, Mican JM, Liu S, Gerber LH, Blackwelder WC, et al. High prevalence of osteonecrosis of the femoral head in HIV-infected adults. Annals of Internal Medicine 137: 17-24, Zhang M, Emerson SU, Nguyen H, Engle R, Govindarajan S, Blackwelder WC, Gerin J, Purcell RH. Recombinant vaccine against hepatitis E: duration of protective immunity in rhesus macaques. Vaccine 20: , Rao MR, Blackwelder WC, Troendle JF, Naficy AB, Clemens JD. Sample size determination for phase II studies of new vaccines. Vaccine 20: , Bricout F, Moraillon A, Sonntag P, Hoerner P, Blackwelder W, Plotkin S. Virus-inhibiting surgical glove to reduce the risk of infection by enveloped viruses. Journal of Medical Virology 69: , Purcell RH, Nguyen H, Shapiro M, Engle RE, Govindarajan S, Blackwelder WC, Wong DC, Prieels J-P, Emerson SU. Pre-clinical immunogenicity and efficacy trial of a recombinant hepatitis E vaccine. Vaccine 21: , Bartosch B, Bukh J, Meunier J-C, Granier C, Engle RE, Blackwelder WC, Emerson SU, Cosset F-L, Purcell RH. In vitro assay for neutralizing antibody to hepatitis C virus: evidence for broadly conserved neutralization epitopes. Proceedings of the National Academy of Sciences 100: , Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. New England Journal of Medicine 350: , Blackwelder WC. Current issues in clinical equivalence trials. Journal of Dental Research 83 (Spec Iss C): C113-C115, Hopkins RJ, Kramer WG, Blackwelder WC, Ashtekar M, Hague L, Winker-La Roche SD, Berezuk G, Smith D, Leese PT. Safety and pharmacokinetic evaluation of intravenous vaccinia immune globulin in healthy volunteers. Clinical Infectious Diseases 39: , Greenberg RN, Kennedy JS, Clanton DJ, Plummer EA, Hague L, Cruz J, Ennis FA, Blackwelder WC, Hopkins RJ. Safety and immunogenicity of new cell-cultured smallpox vaccine compared 8

9 with calf-lymph derived vaccine: a blind, single-centre, randomized controlled trial. Lancet 365: , Simonsen L, Reichert TA, Viboud C, Blackwelder WC, Taylor RJ, Miller MA. Impact of influenza vaccination on seasonal mortality in the US elderly population. Archives of Internal Medicine 165: , Morris CR, Kato GJ, Poljakovic M, Wang X, Blackwelder WC, Sachdev V, Hazen SL, Vichinsky EP, Morris SM Jr, Gladwin MT. Dysregulated arginine metabolism, hemolysis-associated pulmonary hypertension, and mortality in sickle cell disease. Journal of the American Medical Association 294: 81-90, Kato GJ, Martyr S, Blackwelder WC, Nichols JS, Coles WA, Hunter LA, Brennan M-L, Hazen SL, Gladwin MT. Levels of soluble endothelium-derived adhesion molecules in patients with sickle cell disease are associated with pulmonary hypertension, organ dysfunction, and mortality. British Journal of Haematology 130: , Rapoport AP, Stadtmauer EA, Aqui N, Badros A, Cotte J, Chrisley L, Veloso E, Zheng Z, Westphal S, Mair R, Chi N, Ratterree B, Pochran MF, Natt S, Hinkle J, Sickles C, Sohal A, Ruehle K, Lynch C, Zhang L, Porter DL, Luger S, Guo C, Fang HB, Blackwelder W, et al. Restoration of immunity in lymphopenic individuals with cancer by vaccination and adoptive T-cell transfer. Nature Medicine 11: , Grubb JR, Dejam A, Voell J, Blackwelder WC, Sklar PA, Kovacs JA, Cannon RO, Masur H, Gladwin MT. Lopinavir-ritonavir: effects on endothelial cell function in healthy subjects. Journal of Infectious Diseases 193: , Machado RF, Anthi A, Steinberg MH, Bonds D, Sachdev V, Kato GJ, Taveira-DaSiva AM, Ballas SK, Blackwelder W, et al. N-terminal pro-brain natriuretic peptide levels and risk of death in sickle cell disease. Journal of the American Medical Association 296: , Nataro JP, Mai V, Johnson J, Blackwelder WC, Heimer R, Tirrell S, Edberg SC, Braden CR, Morris GJ Jr, Hirshon JM. Diarrheagenic Eschericia coli infection in Baltimore, Maryland and New Haven, Connecticut. Clinical Infectious Diseases 43: , Sachdev V, Machado RF, Shizukuda Y, Rao YN, Sidenko S, Ernst I, St. Peter M, Coles WA, Rosing DR, Blackwelder WC, Castro O, Kato GJ, Gladwin MT. Diastolic dysfunction is an independent risk factor for death in patients with sickle cell disease. Journal of the American College of Cardiology 49: , Kotloff KL, Simon JK, Pasetti MF, Sztein MB, Wooden SL, Livio S, Nataro JP, Blackwelder WC, Barry EM, Picking WD, Levine MM. Safety and immunogenicity of CVD 1208S, a live, oral guaba sen set Shigella flexneri 2a vaccine grown on animal-free media. Human Vaccines 3: , Levine MM, Ferreccio C, Black RE, Lagos R, San Martin O, Blackwelder WC. Ty21a live oral typhoid vaccine and prevention of paratyphoid fever caused by Salmonella enterica Serovar Paratyphi B. Clinical Infectious Diseases 45 Suppl 1: S24-S28, Kelly K, Loskutov A, Zehrung D, Puaa K, LaBarre P, Muller N, Guiqiang W, Ding H, Hu D, Blackwelder WC. Preventing contamination between injectors with multiple-use nozzle-free injectors: a safety trial. Vaccine 26: ,

10 78. Fang C-M, Wang JY, Chinchilla M, Levine MM, Blackwelder WC, Galen JE. Use of mchi encoding immunity to the antimicrobial peptide microcin H47 as a plasmid selection marker in attenuated bacterial live vectors. Infection and Immunity 76: , Lagos R, Muñoz A, San Martin O, Heitmann I, Maldonado A, Hormazabal JC, Blackwelder WC, Levine MM. Age- and serotype-specific pediatric invasive pneumococcal disease: insights from systematic surveillance in Santiago, Chile, Journal of Infectious Diseases 198(12): , Kato GJ, Wang Z, Machado RF, Blackwelder WC, Taylor JG 6 th, Hazen SL. Endogenous nitric oxide synthase inhibitors in sickle cell disease: abnormal levels and correlations with pulmonary hypertension, desaturation, haemolysis, organ dysfunction and death. British Journal of Haemotology 145: , (Epub 2008 Mar 17) 81. Porter BO, Anthony KB, Shen J, Hahn B, Keh CE, Maldarelli F, Blackwelder WC, Lane HC, Kovacs JA, Davey RT, Sereti I. Inferiority of IL-2 alone versus IL-2 with HAART in maintaining CD4 T cell counts during HAART interruption: a randomized controlled trial. Aids 23 (2) Jan 14: , Chawla SP, Chua VS, Fernandez L, Quon D, Saralou A, Blackwelder WC, Hall FL, Gordon EM. Phase I/II and phase II studies of targeted gene delivery in vivo: intravenous Rexin-G for chemotherapy-resistant sarcoma and osteosarcoma. Molecular Therapy 17: , Galen JE, Wang JY, Chinchilla M, Vindurampulle C, Vogel JE, Levy H, Blackwelder WC, Pasetti MF, Levine MM. A new generation of stable, nonantibiotic, low-copy-number plasmids improves immune responses to foreign antigens in Salmonella enterica serovar Typhi live vectors. Infection and Immunity 78: , Chawla SP, Chua VS, Fernandez L, Quon D, Blackwelder WC, Gordon EM, Hall FL. Advanced phase I/II studies of targeted gene delivery in vivo: intravenous Rexin-G for gemcitabine-resistant metastatic pancreatic cancer. Molecular Therapy 18: , Fellows P, Adamovicz J, Hartings J, Sherwood R, Mega W, Brasel T, Barr E, Holland L, Lin W, Rom A, Blackwelder W, Price J, Moris S, Snow D, Hart MK. Protection in mice passively immunized with serum from cynomolgous macaques and humans vaccinated with recombinant plague vaccine (rf1v). Vaccine 28: , Gladwin MT, Kato GJ, Weiner D, Onyekwere OC, Dampier C, Hsu L, Hagar RW, Howard T, Nuss R, Okam MM, Tremonti CK, Berman B, Villella A, Krishnamurti L, Lanzkron S, Castro O, Gordeuk VR, Coles WA, Peters-Lawrence M, Nichols J, Hall MK, Hildesheim M, Blackwelder WC, Baldassarre J, Casella JF. Nitric oxide for inhalation in the acute treatment of sickle cell pain crisis; a randomized controlled trial. Journal of the American Medical Association 305: , Chen WH, Cross AS, Edelman R, Sztein MB, Blackwelder WC, Pasetti MF. Antibody and Th1-type cellmediated immune responses in elderly and young adults immunized with the standard or a high dose influenza vaccine. Vaccine 29: , Thera MA, Doumbo OK, Coulibaly D, Laurens MB, Ouattara A, Kone AK, Guindo AB, Traore K, Traore I, Kouriba B, Diallo DA, Diarra I, Daou M, Dolo A, Tolo Y, Sissoko MS, Niangaly A, Sissoko M, Takala-Harrison S, Lyke KE, Wu Y, Blackwelder WC, et al. A field trial to assess a bloodstage malaria vaccine. New England Journal of Medicine 365: ,

11 89. Gat O, Galen JE, Tennant S, Simon R, Blackwelder WC, Silverman DJ, Pasetti MF, Levine MM. Cell-associated flagella enhance the protection conferred by mucosally-administered attenuated Salmonella Paratyphi A vaccines. Public Library of Science Neglected Tropical Diseases 5(11): e1373, El-Kamary SS, Billington M, Deitz S, Colby E, Rhinehart H, Wu Y, Blackwelder W, et al. Safety and tolerability of the Easy Vax clinical epidermal electroporation system in healthy adults. Molecular Therapy 20: , Farag TH, Nasrin D, Wu Y, Muhsen K, Blackwelder WC, et al. Some epidemiologic, clinical, microbiologic, and organizational assumptions that influenced the design and performance of the Global Enteric Multicenter Study (GEMS). Clinical Infectious Diseases 55 Suppl 4: S , Kotloff KL, Blackwelder WC, Nasrin D, et al.. The Global Enteric Multicenter Study (GEMS) of diarrheal disease in infants and young children in developing countries: epidemiologic and clinical methods of the case/control study. Clinical Infectious Diseases 55 Suppl 4: S232-S245, Blackwelder WC, Biswas K, Wu Y, Kotloff KL, Farag TH, Nasrin D, Graubard BI, Sommerfelt H, Levine MM. Statistical methods in the Global Enteric Multicenter Study. Clinical Infectious Diseases 55 Suppl 4: S246-S253, Sommerfelt H, Steinsland H, van der Merwe L, Blackwelder WC, Nasrin D, Farag TH, Kotloff KL, Levine MM, Gjessing HK. Case/control studies with follow-up: constructing the source population to estimate effects of risk factors on development, disease, and survival. Clinical Infectious Diseases 55 Suppl 4: S261-S270253, Ouattara A, Takala-Harrison S, Thera MA, Coulibaly D, Niangaly A, Saye R, Tolo Y, Dutta S, Heppner DG, Soisson L, Diggs CL, Vekemans J, Cohen J, Blackwelder WC, Dube T, Laurens MB, Doumbo OK, Plowe CV. Molecular basis of allele-specific efficacy of a blood-stage malaria vaccine: vaccine development implications. Journal of Infectious Diseases 207: , Farag TH, Faruque AS, Wu Y, Das SK, Hossain A, Ahmed S, Ahmed D, Nasrin D, Kotloff KL, Panchalingam S, Nataro JP, Cohen D, Blackwelder WC, Levine MM. Housefly population density correlates with shigellosis among children in Mirzapur, Bangladesh: a time series analysis. Public Library of Science Neglected Tropical Diseases 7(6): e2280, Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque ASG, Zaidi AKM, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. The Lancet 382: , Nasrin D, Wu Y, Blackwelder WC, Farag TH, Saha D, Sow SO, Alonso PL, Breiman RF, Sur D, Faruque ASG, Zaidi AKM, Biswas K, Van Eijk AM, Walker DG, Levine MM, Kotloff KL. Health care seeking for childhood diarrhea in developing countries: evidence from seven sites in Africa and Asia. American Journal of Tropical Medicine and Hygiene 89 (1 Supplement): 3-12,

12 99. Baker KK, Sow SO, Kotloff KL, Nataro JP, Farag TH, Tamboura B, Doumbia M, Sanogo D, Diarra D, O Reilly CE, Mintz E, Panchalingham S, Wu Y, Blackwelder WC, Levine MM. Quality of piped and stored water in households with children under five years of age enrolled in the Mali site of the Global Enteric Multicenter Study (GEMS). American Journal of Tropical Medicine and Hygiene 89: , Wall SL, Mazzeo CI, Adejuyigbe EA, Ayede AI, Bahl R, Baqui AH, Blackwelder WC, Brandes N, Darmstatd GL, Esamai F, Hibberd PL, Jacobs M, Klein JO, Mwinga K, Rollins NC, Saloojee H, Tshefu AK, Wammanda RD, Zaidi AKM, Qazi SA. Ensuring quality in AFRINEST and SATT: clinical standardization and monitoring. Pediatric Infectious Disease Journal 32 (Supplement 1): S39-S45, Laurens MB, Thera MA, Coulibaly D, Ouattara A, Kone AK, Guindo AB, Traore K, Traore I, Kouriba B, Diallo DA, Diarra I, Daou M, Dolo A, Tolo Y, Sissoko MS, Niangaly A, Sissoko M, Takala-Harrison S, Lyke KE, Wu Y, Blackwelder WC, Godeaux O, Vekemans J, Dubois M-C, Ballou WR, Cohen J, Dube T, Soisson L, Diggs CL, House B, Bennett JW, Lanar DE, Dutta S, Heppner DG, Plowe CV, Doumbo OK. Extended safety, immunogenicity and efficacy of a bloodstage malaria vaccine in Malian children: 24-month follow-up of a randomized, double-blinded phase 2 trial. Public Library of Science ONE 18;8(11): e79323, Feng C, Zhang L, Nguyen C, Vogel SN, Golblum SE, Blackwelder WC, Cross AS. Neuraminidase reprograms lung tissue and potentiates lipopolysaccharide-induced acute lung injury in mice. Journal of Immunology 191: , Tapia MD, Sow SO, Tamboura B, Keita MM, Berthe A, Samake M, Nataro JP, Onwuchekwa UO, Penfound TA, Blackwelder W, Dale JB, Kotloff KL. Streptococcal pharyngitis in schoolchildren in Bamako, Mali. Pediatric Infectious Disease Journal Epub 2014 Oct Livio S, Strockbine NA, Panchalingam S, Tennant SM, Barry EM, Marohn ME, Antonio M, Hossain A, Mandomando I, Ochieng JB, Oundo JO, Qureshi S, Ramamurthy T, Tamboura B, Adegbola R, Hossain MJ, Saha D, Sen S, Faruque ASG, Alonso PL, Breiman RF, Zaidi AKM, Sur D, Sow SO, Berkeley LY, O Reilly CE, Mintz ED, Biswas K, Cohen D, Farag TH, Nasrin D, Wu Y, Blackwelder WC, Kotloff KL, Nataro JP, Levine MM. Shigella isolates from the Global Enteric Multicenter Study inform vaccine development. Clinical Infectious Diseases 23: , Ramachandran G, Kaempfer R, Chung C-S, Shirvan A, Chahin AB, Palardy JE, Parejo NA, Chen Y, Whitford M, Arad G, Hillman D, Shemesh R, Blackwelder W, Ayala A, Cross AS, Opal SM. CD28 homodimer interface mimetic peptide acts as a preventive and therapeutic agent in models of severe bacterial sepsis and gram-negative bacterial peritonitis. Journal of Infectious Diseases 211: , Heine SJ, Franco-Mahecha OL, Chen X, Choudhari S, Blackwelder WC, van Roosmalen ML, Leenhouts K, Picking WL, Pasetti MF. Shigella IpaB and IpaD displayed on L. lactis bacteriumlike particles induce protective immunity in adult and infant mice. Immunology and Cell Biology 93: , Tennant S, Toema D, Qamar F, Iqbal N, Boyd MA, Marshall J, Blackwelder W, Wu Y, Qadri F, Khan A, Aziz F, Ahmad K, Kalam A, Asif E, Qureshi S, Khan E, Zaidi A, Levine M. Detection of typhoidal and paratyphoidal Salmonella in blood by real-time PCR. Clinical Infectious Diseases 61 (Suppl 4):S241-S250,

13 108. Travassos MA, Beyene B, Adam Z, Campbell JD, Mulholland N, Diarra SS, Kassa T, Oot L, Sequeira J, Reymann M, Blackwelder WC, Wu Y, Ruslanova I, Goswami J, Sow SO, Pasetti MF, Steinglass R, Kebede A, Levine MM. Immunization coverage surveys and linked biomarker serosurveys in Three Regions in Ethiopia. PLoS ONE 11(3): e doi: /journal. pone , Baxter BT, Matsumura J, Curci J, McBride R, Blackwelder WC, Liu X, Larson L, Terrin ML, for the N-TA 3 CT Investigators. Non-invasive treatment of abdominal aortic aneurysm clinical trial (N- TA 3 CT): design of a phase IIb, placebo-controlled, double-blind, randomized clinical trial of doxycycline for the reduction of growth of small abdominal aortic aneurysm. Contemporary Clinical Trials 48: 91-98, Book Chapters 1. Chakravarti IM, Blackwelder WC. On some composition and extension methods in the construction of block designs from association matrices. In Combinatorial Mathematics and its Applications, ed RC Bose and TA Dowling. University of North Carolina Press, Chapel Hill, , Blackwelder WC. Acellular pertussis vaccine efficacy determined from clinical criteria. In Manclark CR (ed), Proceedings of the Sixth International Symposium on Pertussis. DHHS Publication No. (FDA) Department of Health and Human Services, Bethesda, Maryland, , Blackwelder WC. Similarity/equivalence trials for combination vaccines. In Combined Vaccines and Simultaneous Administration: Current Issues and Perspectives, ed. JC Williams, KL Goldenthal, DL Burns, BP Lewis. Annals of the New York Academy of Sciences 754: , Blackwelder WC, VanRaden MJ, Deloria MA. Estimation of pertussis vaccine efficacy in the presence of covariates in three randomized trials. In Pertussis Vaccine Trials, ed. F Brown, D Greco, S Wassilak. Developments in Biological Standardization, Karger, Basel, vol. 89, , Blackwelder WC. Equivalence trials. In Encyclopedia of Biostatistics, ed. P Armitage & T Colton. Wiley, New York. Vol. 2, , Blackwelder WC. Equivalence trials. In Biostatistics in Clinical Trials, ed. CK Redmond & T Colton. Wiley, New York , Simonsen L, Reichert TA, Blackwelder W, Miller MA. Benefits of influenza vaccination on influenza-related mortality among elderly in the US: an unexpected finding. In Options for the Control of Influenza V, Kawaoka ed. Elsevier, International Congress Series: 1263; , Abstracts and/or Proceedings 1. Stemmermann GN, Rhoads GG, Blackwelder WC. Atherosclerosis and its risk factors in the Hawaiian Japanese. In Atherosclerosis IV: Proceedings of the Fourth International Symposium, ed Schettler G, Goto Y, Hata Y, Klose G. Springer-Verlag, New York, 1977, pp

14 2. Bartosch B, Bukh J, Meunier JC, Granier C, Engle RE, Blackwelder WC, Emerson SU, Cosset FL, Purcell RH. In vitro assay for neutralizing antibody to hepatitis C virus: evidence for broadly conserved neutralization epitopes. Proceedings of the National Academy of Sciences U S A 100: , Other Brief communications 1. Blackwelder WC (letter). Comparing antibiotics: statistical rigor vs. practicality. Journal of the American Medical Association 254:3311, Blackwelder WC, Elston RC (letter). Comment on Dr. Robertson's communication. Behavior Genetics 4:97-99, Stuart-Harris CH, Blackwelder WC, Alling DW (reply to letter). American Journal of Epidemiology 115: , Saah AJ, Blackwelder, WC, Kaslow RA (commentary). Treatment of acute otitis media. Journal of the American Medical Association 248: , Polis MA, Blackwelder WC (letter). Trimethoprim-sulfamethoxazole or pentamidine for Pneumocystis carinii pneumonia. Annals of Internal Medicine 106:475, Orenstein WA, Wassilak SGF, Strebel PM, Bernier RH, Blackwelder WC (letter). Efficacy of pertussis vaccine. Journal of Pediatrics 117:508, Ehrenranz NJ, Blackwelder WC, Pfaff SJ, Poppe D, Yerg DE, Kaslow RA (letter). Re: Infections complicating low-risk cesarean sections in community hospitals: efficacy of antimicrobial prophylaxis. American Journal of Obstetrics and Gynecology 164: , Blackwelder WC (letter). Design of active control equivalence trials. Journal of Acquired Immune Deficiency Syndromes 5: , Blackwelder WC. Showing a treatment is good because it is not bad: when does noninferiority imply effectiveness? (Commentary) Controlled Clinical Trials 23: 52-54, Simonsen L, Morens DM, Blackwelder WC. Ecological studies, rotavirus vaccination, and intussusception (letter). Lancet 359: , Simonsen L, Blackwelder WC, Reichert TA, Miller MA. Estimating deaths due to influenza and respiratory syncytial virus (letter). Journal of the American Medical Association 289: ,

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