Karen L. Kotloff, MD

• Washington University, B.A., Psychology, 1975
• Temple University School of Medicine, M.D., 1979
• Internship and Residency, Children's Hospital of Pittsburgh, Pediatrics, 1980-83
• Fellowship, University of Maryland School of Medicine, Infectious Disease, 1983-86

Dr. Kotloff joined the faculty at the University of Maryland School of Medicine (UMSOM) in 1986. She currently serves as Head of the Division of Infectious Disease and Tropical Pediatrics and Associate Director of Clinical Studies at the Center for Vaccine Development and Global Health (CVD).  She is board certified in Pediatrics and Pediatric Infectious Disease and cares for children with a wide range of infectious diseases on the inpatient and outpatient service at the University of Maryland Medical Center (UMMC).

Dr. Kotloff's research focuses on the epidemiology of infectious diseases and their prevention with the use of vaccines in both the U.S. and developing countries. She is Principal Investigator (PI) of the Vaccine Treatment and Evaluation Unit (VTEU) at the UMSOM's Center for Vaccine Development and Global Health funded by the National Institute of Allergy and Infectious Disease. This contract funds vaccines and treatments against infectious diseases of public health importance. She has designed and performed many clinical trials to evaluate a wide array of vaccines, adjuvants, delivery mechanisms, and medications, in all age groups, from premature infants to the elderly, and in both healthy subjects and in those with underlying medical conditions. She has focused clinical development of vaccines and other preventive strategies for which I know the need is great, but that face challenges that have stalled the path to licensure. She has worked to find solutions to the impediments and try to advance the clinical development of these vaccines. Currently she has leadership roles in two large Phase 3 COVID-19 vaccine trials in the U.S.

Dr. Kotloff has led numerous large epidemiologic studies of infectious diseases responsible for child mortality in Africa and Asia, aiming to provide the information necessary to develop effective interventions.  These include the GEMS and VIDA studies of diarrheal disease as well as CHAMPS (minimally invasive post-mortem biopsies to determine cause of death), ABCD (azithromycin treatment of severe diarrhea), and PERCH (epidemiology of pneumonia).  Currently she leads SANTE, a randomized controlled trial of azithromycin given to pregnant women and infants to prevent stillbirths and infant mortality.  She participates in numerous international advisory committees for the Bill & Melinda Gates Foundation and the World Health Organization.  For her contributions that led to introduction of vaccines in Mali, she was awarded Chevalier de l’Ordre National du Mali (Knight of the National Order of Mali) in 2005 by the President of Mali.

Infectious disease, vaccines, clinical trials, diarrheal diseases, group A streptococcus, Shigella, influenza, infant mortality, GEMS, CHAMPS, VIDA, VTEU, azithromycin, child survival.

Baden, L. R., El Sahly, H. M., Essink, B., Kotloff, K., Frey, S., Novak, R., Diemert, D., Spector, S. A., Rouphael, N., Creech, C. B., McGettigan, J., Khetan, S., Segall, N., Solis, J., Brosz, A., Fierro, C., Schwartz, H., Neuzil, K., Corey, L., Gilbert, P., Janes, H., Follmann, D., Marovich, M., Mascola, J., Polakowski, L., Ledgerwood, J., Graham, B. S., Bennett, H., Pajon, R., Knightly, C., Leav, B., Deng, W., Zhou, H., Han, S., Ivarsson, M., Miller, J. and Zaks, T. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.  N Engl J Med 2021; 384: 403-16.

Kotloff KL, Shirley D-A-T-, Creech CB, Frey SE, Harrison CJ, Staat M, Anderson EJ, Dulkerian S, Thomsen IP, Al-Hosni M, Pahud BA, Bernstein DI, Yi J, Petrikin JE, Haberman B, Stephens K, Stephens I, Oler RE Jr, Conrad TM. Mupirocin for Staphylococcus aureua Decoloniation of Infants in Neonatal Intensive Care Units. Pediatrics 2019;143:e20181565.

Kotloff KL. Nasrin D, Blackwelder WC, Wu Y, Farag T, Panchalingham S, et al. The incidence, etiology, and adverse clinical consequences of less severe diarrheal episodes among infants and children residing in developing countries: a 12-month follow-on investigation to the Global Enteric Multcenter Study (GEMS). Lancet Glob Health 2019;7: e568-e584.

Kotloff KL, Riddle MS, Platts-Mills JA, Pavlinac P, Zaidi AKM. Shigellosis. Lancet 2018; 391: 801-12.

Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D,  Farag TH, Panchalingam S, Wu Y, Sow SO, Breiman RF, Faruque ASG, Zaidi AKM, Saha D,  Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanugo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonia 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. Lancet 2013; 382:209-22.