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Karen L. Kotloff, MD

John A. Scholl, MD and Mary Louise Scholl, MD Professor of Pediatrics

Academic Title:


Primary Appointment:


Secondary Appointment(s):

Medicine, Epidemiology & Public Health

Additional Title:

Distinguished Professor


HSF1, Room 480

Phone (Primary):

(410) 706-5328


(410) 706-6205

Education and Training

  • 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.

Research/Clinical Keywords

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

Highlighted Publications

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.

Additional Publication Citations

Levine MM, Nasrin D, Acacio S, Bassat Q, Powell H, Tennant SM, Sow SO, Sur D, Zaidi AKM, Faruque ASG, Hossain MJ, Alonso PL, Breiman RF, O'Reilly CE, Mintz ED, Omore R, Ochieng JB, Oundo JO, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ahmed S, Qureshi S, Quadri F, Hossain A, Das SK, Antonio M, Saha D, Mandomando I, Blackwelder WC, Farag T, Wu Y, Houpt ER, Verweiij JJ, Sommerfelt H, Nataro JP, Robins-Browne RM, Kotloff KLDiarrheoal disease and subsequent risk of death in infants and children residing inlow-income and middle-income countries: analysis of the GEMS case-control study and 12-month GEMS-1A follow-on study. Lancet Glob Health 2020; 8(2): e204-e14.

Shane AL, Sato AI, Kao C, Adler-Shohet FC, Vora SB, Ery J, Auletta J, Nachman S, Raabe VN, Inagaki K, Akinboyo IC, Woods C, Alsulami AO, Kainth MK, Santos RP, Espinosa CM, Burns JE, Cunningham CK, Dominguez SR, Larru Martinez B, Zhu F, Crews J, Kitano T, Saiman L, Kotloff K. A Pediatric Infectious Disease Perspective of SARS-CoV-2 and COVID-19 in ChildrenJ Pediatric Infect Dis Soc 2020 Aug 25;. doi: 10.1093/jpids/piaa099.

Shane AL, Mody RK, Crump JA, Tarr PI, Steiner TS, Kotloff K, Langley JM, Wanke C, Warren CA, Cheng AC, Cantey J, Pickering LK. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clin Infect Dis 2017; 65:1963-73.

Barger-Kamate B., Deloria Knoll M., Kagucia E.W., Prosperi C., Baggett H.C., Brooks W.A., Feikin D.R., Hammitt L.L., Howie S.R., Levine O.S., Madhi S.A., Scott J.A., Thea D.M., Amornintapichet T., Anderson T.P., Awori J.O., Baillie V.L., Chipeta J., DeLuca A.N., Driscoll A.J., Goswami D., Higdon M.M., Hossain L., Karron R.A., Maloney S., Moore D.P., Morpeth S.C., Mwananyanda L., Ofordile O., Olutunde E., Park D..E, Sow S.O, Tapia M.D., Murdoch D.R., O'Brien K.L., Kotloff KL. Pertussis-Associated Pneumonia among Infants and Children from Low- and Middle-Income Countries Participating in the PERCH Study. Clin Infect Dis;2016; 63(suppl 4):S187-S196.

Kotloff, KL, Halasa NB, Harrison CJ, Englund JA, Walter EB, King JC, Creech CB, Healy SA, Dolor RJ, Stephens I, Edwards KM, Noah DL, Hill H, Wolff M. Clinical and immune responses to inactivated influenza A(H1N1)pdm09 vaccine in children. Pediatr Infect Dis J 2014; 33:865-71.

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. Pediatr Infect Dis J 2014;34:463-8.

Sow SO, Tapia MD, Diallo S, Keita MM, Sylla M, Onwuchekwa U, Pasetti MF, Kotloff KL, Levine MM. Haemophilus influenzae type b conjugate vaccine introduction in Mali: impact on disease burden and serologic correlate of protection. Am J Trop Med Hyg 2009;80:1033-1038.

Kotloff KL, Pasetti MF, Barry EM, Nataro JP, Wasserman SS, Sztein MB, Picking WD, Levine MM. Deletion in the Shigella enterotoxin genes further attenuates Shigella flexneri 2a bearing guanine auxotrophy in a Phase 1 trial of CVD 1204 and CVD 1208. J Infect Dis 2004;190:1745-54.

Kotloff KL, Corretti M, Palmer K, Campbell JD, Reddish MA, Hu MC, Dale JB. Safety and immunogenicity of a recombinant multivalent group A streptococcal vaccine in healthy adults Phase I trial. JAMA 2004; 292:709-15.

Kotloff KL, Winickoff JP, Ivanoff B, Clemens JD, Swerdlow DL, Sansonetti PJ, Adak GK, Levine MM. Global burden of Shigella infections: Implications for vaccine development and implementation of control strategies. Bull WHO 1999;77:651-666.

Research Interests

Dr. Kotloff's research interests include the epidemiology of infectious diseases in children living in developing countries, prevention of child mortality, and clinical vaccine trials.

Clinical Specialty Details

Pediatric Infectious Disease

Awards and Affiliations

  • 2021: Distinguished Professor, University of Maryland, Baltimore
  • 2019: Temple University School of Medicine Alumni Achievement Award
  • 2018: Founders' Day Research of the Year, Univerity of Maryland, Baltimore
  • 2013, 2014: Baltimore Magazine’s Best Doctors: Pediatric Infectious Disease
  • 2005: Chevalier de l’Ordre National du Mali (Knight of the National Order of Mali)
  • 1987‐88: Alexander I. Shaeffer Teaching Award for Outstanding Contributions to Housestaff Education

Grants and Contracts

Karen Kotloff, M.D. (PI)
NIAID, NIH 2UM1AI148689-02
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site

Karen Kotloff, M.D. (PI)
Bill & Melinda Gates Foundation
Assessment of azithromycin impact to optimize future program design in Mali

Karen Kotloff, M.D. (PI)
Bill & Melinda Gates Foundation
COVID-19 surveillance leveraging existing platforms in CVD-Mali

Karen Kotloff, M.D. (Site PI)
Emory Global Health Institute/Bill & Melinda Gates Foundation
Child Health and Mortality Prevention Surveillance (CHAMPS)

Karen Kotloff, M.D. (Site PI)
University of Washington, Bill & Melinda Gates Foundation
Enterics for Global Health (EFGH) Part A – Site Readiness

Karen Kotloff, M.D. (PI)
Bill & Melinda Gates Foundation
Rotavirus Impact Studies in Africa (VIDA)

Karen Kotloff, M.D. (Site PI)
Vysnova Partners, Inc./CDC
Applied Research to Address the COVID-19 Emerging Public Health Emergency (Site PI)

Karen Kotloff, M.D. (co-investigator)
NIAID, NIH - 1R01AI135114-01A1 (D. Leung, PI)
Development of clinical decision tools for management of diarrhea of children in high and low resource settings