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Karen L. Kotloff, MD

Academic Title:


Primary Appointment:


Secondary Appointment(s):

Medicine, Epidemiology & Public Health

Administrative Title:

Division Head, Ped-Infectious Diseases And Tropical Medicine


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 at the UMSOM's Center for Vaccine Development funded by the National Institute of Allergy and Infectious Disease. This contract funds vaccines and treatments against infectious diseases of public health importance.

Dr. Kotloff has led numerous clinical trials to evaluate vaccines against a wide range of infections, including group A streptococcus, Shigella, and influenza. She is also PI of three grants funded by the Bill & Melinda Gates Foundation to study prevention and treatment of diarrheal diseases and to conduct intensive studies of the causes of death among infants and children in developing countries. She participates in numerous international advisory committees for the Bill & Melinda Gates Foundation and the World Health Organization.

Research/Clinical Keywords

Infectious disease, vaccines, clinical trials, group A streptococcus, Shigella, influenza, infant mortality, GEMS, CHAMPS, VIDA, VTEU.

Highlighted Publications

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.

Liu J, Platts-Mills JA, Juma J, Kabir F, Nkeze J, Okoi C, Operario DJ, Uddin J, Ahmed S, Alonso PL, Antonio M, Becker SM, Blackwelder WC, Breiman RF, Faruque AS, Fields B, Gratz J, Haque R, Hossain A, Hossain MJ, Jarju S, Qamar F, Iqbal NT, Kwambana B, Mandomando I, McMurry TL, Ochieng C, Ochieng JB, Ochieng M, Onyango C, Panchalingam S, Kalam A, Aziz F, Qureshi S, Ramamurthy T, Roberts JH, Saha D, Sow SO, Stroup SE, Sur D, Tamboura B, Taniuchi M, Tennant SM, Toema D, Wu Y, Zaidi A, Nataro JP, Kotloff KL, Levine MM, Houpt ER. Use of quantitative molecular diagnostic methods to identify causes of diarrhoea in children: A reanalysis of the GEMS case-control study. Lancet 2016;388:1291-1301.

Sow SO, Muhsen K, Nasrin D, Blackwelder WC, Wu Y, Farag TH, Panchalingam S, Sur D, Zaidi AK, Faruque AS, Saha D, Adegbola R, Alonso PL, Breiman RF, Bassat Q, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ahmed S, Qureshi S, Quadri F, Hossain A, Das SK, Antonio M, Hossain MJ, Mandomando I, Nhampossa T, Acacio S, Omore R, Oundo JO, Ochieng JB, Mintz ED, O'Reilly CE, Berkeley LY, Livio S, Tennant SM, Sommerfelt H, Nataro JP, Ziv-Baran T, Robins-Browne RM, Mishcherkin V, Zhang J, Liu J, Houpt ER, Kotloff KL, Levine MM. The burden of Cryptosporidium diarrheal disease among children; 24 months of age in moderate/high mortality regions of sub-saharan Africa and south Asia, utilizing data from the Global Enteric Multicenter Study (GEMS). PLoS Negl Trop Dis 2016;10:e0004729.

Libster R, McNeal M, Walter EB, Shane AL, Winokur P, Cress G, Berry AA, Kotloff KL, Sarpong K, Turley CB, Harrison CJ, Pahud BA, Marbin J, Dunn J, El‐Khorazaty J, Barrett J, Edwards KM. VTEU Rotavirus Vaccine Study Work Group. Safety and immunogenicity of sequential rotavirus vaccine schedules. Pediatrics 2016; 137:1‐10.

Nasrin D, Wu Y, Blackwelder WC, Farag TH, Saha D, Sow SO, Alonso PL, Breiman RF, Sur D, Faruque AS, Zaidi AK, Biswas K, van Eijk AM, Levine MM, Kotloff KL. Health care seeking for childhood diarrhea in developing countries: Evidence from seven sites in Africa and Asia. Am J Trop Med Hyg 2013; 89(1 Suppl):3-12.

Chen WH, Jackson LA, Edwards KM, Keitel WA, Hill H, Noah DL, Creech CB, Patel SM, Mangal B, Kotloff KL. Persistence of antibody to influenza A/H5N1 vaccine virus: impact of AS03 adjuvant. Clin Vaccine Immunol 2015; 23:73‐7.

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.

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.

Kotloff KL, Blackwelder WD, Nasrin D, Nataro JP, Farag TH, van Eijk A, Adegbola RA, Alonso PL, Breiman RF, Faruque ASG, Saha D, Sow SO, Sur D, Zaidi AKM, Biswas K, Panchalingam S, Clemens JD, Cohen D, Glass RI, Mintz ED, Sommerfelt H, Levine MM. The Global Enterics Multicenter Study (GEMS) of diarrheal disease in infants and young children in developing countries: Epidemiologic and clinical methods of the case-control study. Clin Infect Dis 2012;55 Suppl 4:S232-45.

Additional Publication Citations

Baker KK, O'Reilly CE, Levine MM, Kotloff KL, Nataro JP, Ayers TL, Farag TH, Nasrin D, Blackwelder WC, Wu Y, Alonso PL, Breiman RF, Omore R, Faruque AS, Das SK, Ahmed S, Saha D, Sow SO, Sur D, Zaidi AK, Quadri F, Mintz ED. Sanitation and hygiene-specific risk factors for moderate-to-severe diarrhea in young children in the Global Enteric Multicenter Study, 2007-2011: Case-control study. PLoS Med 2016;13:e1002010.

Checkley W, White AC Jr, Jaganath D, Arrowood MJ, Chalmers RM, Chen X, Fayer R, Griffiths JK, Guerrant RL, Hedstrom L, Huston CD, Kotloff KL, Kang G, Mead JR, Miller M, Petri WA Jr, Priest JW, Roos DS, Striepen B, Thompson RC, Ward HD, Van Voorhis WA, Xiao L, Zhu G, Houpt ER. A review of the global burden, novel diagnostics, therapeutics, and vaccine targets for cryptosporidium. Lancet Infect Dis 2015; 15:85‐94.

Munoz FM, Weisman LE, Read JS, Siberry G, Kotloff K, Friedman J, Higgins RD, Hill H, Seifert H, Nesin M. Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy. Clin Infect Dis 2014;59 Suppl 7:S415‐27.

Chen WH, Jackson LA, Edwards KM, Keitel WA, Hill H, Noah DL, Creech CB, Patel SM, Mangal B, Kotloff KL. Safety, reactogenicity, and immunogenicity of inactivated monovalent influenza A (H5N1) virus vaccine administered with or without ASO3 adjuvant. Open Forum Infect Dis 2014;1:ofu091.

Jackson LA, Campbell JD, Frey SE, Edwards KM, Keitel WA, Kotloff KL, Berry AA, Graham I, Atmar RL, Creech CB, Thomsen IP, Patel SM, Gutierrez AF, Anderson EL, El Sahly HM, Hill H, Noah DL, Bellamy AR. Effect of varying doses of a monovalent H7N9 influenza faccine with and without AS03 and MF59 adjuvants on immune response: A randomized clinical trial. JAMA 2015;314:237‐46.

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 and clinical vaccine trials.

Clinical Specialty Details

Pediatric Infectious Disease

Awards and Affiliations

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)
2013 – 2023
National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH)
Vaccine and Treatment Evaluation Units (VTEU)  

  • Design and conduct clinical trials and studies to evaluate diagnostic, preventive and therapeutic measures against viral, bacterial, parasitic and fungal pathogens, including the NIAID priority biodefense pathogens and emerging infectious disease pathogens, in populations of all ages and risk categories.

Karen Kotloff, M.D. (PI)
07/16/2014 – 02/28/2019
Bill & Melinda Gates Foundation
Rotavirus Impact Studies in Africa (Vaccine Impact on Diarrhea in Africa, VIDA)

  • Measure the impact of rotavirus vaccine introduction on the etiology and outcome of moderate-to-severe diarrhea among infants and children living in three developing countries of Africa.

Karen Kotloff, M.D. (PI)
Merck  Corporation

  • Surveillance study to monitor effectiveness and safety of vaccine vial monitor compatible formulation of RotaTeq in routine use in a developing world setting.

Karen Kotloff, M.D. (Mali site co-PI)
Emory University (sponsor Bill & Melinda Gates Foundation)           
Child Health and Mortality Prevention Surveillance (CHAMPS) Network

  • Participate in a long-term network of high-quality sites to collect robust and standardized primary data with the overriding objective of identifying and tracking the preventable causes of childhood death globally.

Karen Kotloff, M.D. (Mali site co-PI)
Johns Hopkins School of Public Health (sponsor Bill & Melinda Gates Foundation)
Pneumonia Etiology and Research for Child Health (PERCH)