Karen Kotloff is Professor of Medicine and Pediatrics, Head of Infectious Disease and Tropical Pediatrics, and Associate Director of Clinical Studies at the Center for Vaccine Development. She received her B.A. in Psychology from Washington University in 1975, and her M.D. from Temple University in 1979. Dr. Kotloff completed her residency in Pediatrics at the Children’s Hospital of Pittsburgh, and her fellowship in Infectious Diseases at the University of Maryland School of Medicine. She joined the faculty of the Center for Vaccine Development and the Department of Pediatrics, University of Maryland School of Medicine in 1987.
Dr. Kotloff’s performs clinical and epidemiological studies in the U.S. and in developing countries. Having focused on studies of the epidemiology and etiology of pediatric diarrheal diseases in the U.S. during her fellowship training, she continued this interest as a faculty member studying the incidence, etiology, and nutritional consequences of diarrheal disease among children born to HIV-infected mothers. Most recently, she was the principal investigator of the clinical and epidemiological activities in the Global Enterics Multicenter Study, a 3-year, population-based, case-control study of the incidence, etiology, and clinical outcomes of moderate-to-severe diarrhea among children 0 to 59 months of age living at study sites in seven developing countries of sub-Saharan Africa and south Asia. Dr. Kotloff’s work in Mali, West Africa has been a particular focus. She collaborated with colleagues at the CVD and the Ministry of Health in Mali to develop a research and training field site in Bamako, Mali and assisted in numerous training activities, epidemiologic studies of pediatric infections, and vaccine trials. She was a co-investigator of a study to measure the disease burden of Haemophilus influenzae type b and the impact of vaccine introduction, and was awarded the Chevalier de l’Ordre National du Mali (Knight of the National Order of Mali) by the President of Mali for this work. Dr. Kotloff has over 20 years of experience conducting Phase 1-4 clinical vaccine trials. One major focus is the design of “first in humans” Phase 1 studies to evaluate vaccines that are hindered in their development either because of safety issues or because the target market is poor populations in developing countries which lacks commercial appeal, such as vaccines against Group A streptococcus. She has one of the most extensive experiences worldwide with clinical trials of live bacterial vaccines, e.g., Shigella and Salmonella ParatyphiA vaccines. In developing countries, she has conducted trials to evaluate vaccines against cholera, rotavirus, and influenza, as well as pediatric combination vaccines. In 2007, she was awarded a contract from NIAID to serve as principal investigator of one of the eight funded Vaccine Testing and Evaluation Units in the U.S. for which the CVD has conducted more than 20 clinical vaccine trials.
Pediatric infectious disease
- Kotloff KL, Nataro, JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingham S, Wu Y, Sow SO, Sur, 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, Acácio S, Biswas K, O’Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, and 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, in press.
- 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. Healthcare-Seeking for Childhood Diarrhea in Developing Countries: Evidence from Seven Sites in Africa and Asia. Am J Trop Med Hyg 2013, in press.
- Barry EM, Pasetti MF, Sztein MB, Fasano A, Kotloff KL, Levine MM. Progress and pitfalls in Shigella vaccine research. Nat Rev Gastroenterol Hepatol 2013; 10:245-55.
- Kotloff K.L., Blackwelder W.D., Nasrin D., Nataro J.P., Farag T.H., van Eijk A., Adegbola R.A., Alonso P.L., Breiman R.F., Faruque A.S.G., Saha D., Sow S.O., Sur D., Zaidi A.K.M., Biswas K., Panchalingam S., Clemens J.D., Cohen D., Glass R.I., Mintz E.D., Sommerfelt H., Levine M.M. 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.
- Chen W.H., Winokur P.L., Edwards K.M., Jackson L.A., Wald A., Walter E.B., Noah D.L., Wolff M., Kotloff K.L. and the Pandemic H1N1 Vaccine Adult Study Group. Phase 2 assessment of the safety and immunogenicity of two inactivated pandemic monovalent H1N1 vaccines in adults as a component of the U.S. pandemic preparedness plan in 2009. Vaccine. 2012;30:4240-8.
- Sow S.O., Tapia M., Haidara F.C., Ciarlet M., Diallo F., Kodio M., Doumbia M., Dembélé R.D., Traoré O., Onwuchekwa U.U., Lewis K.D., Victor J.C., Steele A.D., Neuzil K.M., Kotloff K.L., Levine M.M. Efficacy of the oral pentavalent rotavirus vaccine in Mali. Vaccine. 2012;30 Suppl 1:A71-8.
- Levine O.S., O'Brien K.L., Deloria-Knoll M., Murdoch D.R., Feikin D.R., Deluca A.N., Driscoll A.J., Baggett H.C., Brooks W.A., Howie S.R., Kotloff K.L., Madhi S.A., Maloney S.A., Sow S., Thea D.M., Scott J.A. The pneumonia etiology research for child health project: a 21st century childhood pneuomonia etiology study. Clin Infect Dis. 2012;54 Suppl 2:S93-S101.
- El Sahly, H.M., Davis C., Kotloff K.L., Meier J., Winokur P.L., Wald A., Johnston C., George S.L., Brady R.C., Lehmann C., Stokes-Riner A., Keitel W.A. Higher antigen content improves the immune response to 2009 H1N1 Influenza vaccine in HIV-infected adults: a randomized clinical trial. J Infect Dis 2012;205:703-12.
- Sow S.O., Tapia M.D., Diallo S., Sow S.O., Tapia M.D., Diallo S., Keita M.M., Sylla M., Onwuchekwa U., Pasetti M.F., Kotloff K.L., Levine M.M. Haemophilus influenzae type b conjugate vaccine introduction in Mali: impact on disease burden and serologic correlate of protection. Am J Trop Med Hyg 2009;80:1033-8.
- Milstien J.B., Tapia M., Sow S.O., Keita L., Kotloff K. Strengthening immunization in a West African country: Mali. Educ Health. 2007;20: article 120.
- Campbell J.D., Clement K.H., Wasserman S.S., Donegan S. Chrisley L., Kotloff K.L. Safety, reactogenicity and immunogenicity of a recombinant protective antigen anthrax vaccine given to healthy adults. Hum Vaccin 2007;3:205-11.
- Levine M.M., Kotloff K.L., Barry E.M., Pasetti M.F, Sztein M.B. Clinical trials of Shigella vaccines: two steps forward and one step back on a long, hard road. Nat Rev Microbiol 2007; 5:540-53.
- Sow S., Diallo S., Campbell J., Tapia M., Keita T., Keita M.M., Murray P., Kotloff K., Levine M.M. Burden of invasive disease caused by Haemophilus influenzae type b in Bamako, Mali: impetus for routine infant immunization with conjugate vaccine. Pediatr Infect Dis J 2005;24:533-7.
- Lee H., Kotloff K., Chukaserm P., Samosornsuk S., Chompook P., Deen J.L., von Seidlein L., Clemens J.D., Wanpen C. Shigellosis remains an important problem in children less than 5 years of age in Thailand. Epidemiol Infect 2005;133:469-74.
- Kotloff K.L., Pasetti M.F., Barry E.M., Nataro J.P., Wasserman S.S., Sztein M.B, Picking W.D., Levine M.M. 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 K.L., Corretti M., Palmer K., Campbell J.D., Reddish M.A., Hu M.C., Dale J.B. Phase 1 trial of the safety and immunogenicity of a recombinant multivalent group A streptococcal vaccine in healthy adult volunteers. JAMA 2004;292:709-15.
- Campbell J.D., Kotloff K.L., Sow S.O., Tapia M., Keita M.M., Keita T., Diallo S., Hormazabal J.C., Murray P., Levine M. Invasive pneumococcal infections among hospitalized children in Bamako, Mali. Pediatr Infect Dis J 2004; 23:742-9.
- Campbell J.D., Sow S.O., Levine M.M., Kotloff K.L. The causes of hospital admission and death among children in Bamako, Mali. J Trop Pediatr 2004;50:158-63.
- Kotloff K.L. Human challenge studies with infectious agents. J Invest Med 2003; 51:S6-11.
- Kotloff K.L., Taylor D.N., Sztein M.B., Wasserman S.S., Losonsky G.A., Nataro, J.P., Venkatesan M., Hartman A., Picking W.D., Katz D.E., Campbell J.D., Levine M.M., Hale T.L. Phase I evaluation of a virG deleted Shigella sonnei live, attenuated, oral vaccine (Strain WRSS1) in healthy adults. Infect Immun 2002; 70:2016-2021.
- Kotloff K.L., Sztein M.B., Wasserman S.S., Losonsky G.A., DiLorenzo S.C., Walker R.I. Safety and immunogenicity of oral inactivated whole cell Helicobacter pylori vaccine with adjuvant among volunteers with or without subclinical infection. Infect Immun 2001; 69:3581 3590.
- Kotloff K.L., Wasserman S.S., Losonsky G.A., Thomas W., Jr., Nichols R., Edelman R., Bridwell M., Monath T.P. Safety and immunogenicity of ascending doses of a Clostridium difficile toxoid vaccine administered to healthy adults. Infect Immun 2001; 69:988-995.
- Treanor J.J., Kotloff K., Betts R.F., Belshe R., Newman F., Iacuzio D., Wittes J., Bryant M. Efficacy of trivalent, live, cold-adapted influenza vaccine (CAIV-T) in prevention of virus infection and illness following challenge of adults with wild-type influenza A (H1N1), A (H3N2), and B viruses. Vaccine 2000; 18:899-906.
- Tacket C.O., Cohen M.B., Wasserman S.S., Losonsky G., Livio S., Kotloff K., Edelman R., Kaper J.B., Cryz S.J., Giannella R.A., Schiff G., Levine M.M. Randomized, double-blind, placebo-controlled, multi-centered trial of the efficacy of a single dose of live oral cholera vaccine CVD 103-HgR in preventing cholera following challenge with Vibrio cholerae O1 El Tor, Inaba three months after vaccination, Infect Immun 1999;67:6341-6345.
- Kotloff K.L., Winickoff J.P., Ivanoff B., Clemens J.D., Swerdlow D.L., Sansonetti P.J., Adak G.K., Levine M.M. Global burden of Shigella infections: Implications for vaccine development and implementation of control strategies. Bull WHO 1999;77:651-666.
- Michetti P., Kreiss C., Kotloff K.L., Porta N., Blanco J.L, Bachmann D., Herranz M., Saldinger P.F., Corthésy-Theulaz, Losonsky G., Nichols R., Simon J., Stolte M., Ackerman S., Monath T.P., Blum A.L. Oral immunization with recombinant urease and E. coli heal labile enterotoxin adjuvant is safe and immunogenic in H. pylori infected adults. Gastroenterology 1999;116:804-812.
- Lagos R., Kotloff K., Hoffenbach A., San Martin O., Abrego P., Ureta A.M., Pines E., Blondeau C., Bailleux F., Levine M.M. Clinical acceptability and immunogenicity of a pentavalent parenteral combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, and Haemophilus influenzae type b conjugate antigens in 2-, 4-, and 6-month- old Chilean infants. Pediatr Infect Dis J 1998; 17:294-304.
- Belshe R.B., Mendelman P.M., Treanor J., King J., Gruber W.C., Piedra P., Bernstein D.I., Hayden F.G., Kotloff K., Zangwill K., Reisinger K., Block S.L., Wittes J., Rabinovich R., Iacuzio D., Wolff M. Efficacy of trivalent live attenuated intranasal influenza vaccine in children. N Engl J Med 1998;338:1405-1412.
- Kotloff K.L., Noriega F., Losonsky G.A., Wasserman S.S., Nataro J.P., Levine M.M. Safety, immunogenicity, and transmissibility in humans of CVD 1203, a live oral Shigella flexneri 2a vaccine candidate attenuated by deletions in aroA and virG. Infect Immun 1996; 64:4542-4548.
- Kotloff K.L., Nataro J.P., Losonsky G.A., Wasserman S.S., Hale T.L., Taylor D.N., Sadoff J.C., Levine M.M. A modified Shigella volunteer challenge model in which the inoculum is administered with bicarbonate buffer: Clinical experience and implications for Shigella infectivity. Vaccine 1995;13:1488-1494.
- Kotloff K.L., Johnson J.P., Nair P., Hickman D., Lippincott P., Wilson D., Clemens J.D. Diarrheal morbidity during the first two years of life among HIV-infected infants. JAMA 1994;271:448-452.
- Kotloff K.L., Wasserman S.S., O'Donnell S., Losonsky G.A., Cryz S.J., Levine M.M. Safety and immunogenicity in North Americans of a single dose of live oral cholera vaccine CVD 103-HgR: Results of a randomized, placebo-controlled, double-blind cross-over trial. Infect Immun 1992;60:4430-4432.
- Kotloff K.L., Tacket C.O., Clemens J.D., Wasserman S.S., Cowan J.E., Bridwell M.W., Quinn T.C. Assessment of the prevalence and risk factors for HIV 1 infection among college students using three survey methods. Am J Epidemiol 1991;133:2-8.
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