| Primary Instructors | Guest Lecturers | ||
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Chris Beyrer, MD, MPH Associate Professor, Johns Hopkins Bloomberg School of Public Health Chris Beyrer is an associate research professor in the Department of Epidemiology in the Johns Hopkins Bloomberg School of Public Health. He has a joint appointment in the Department of International Health. Dr. Beyrer received his medical degree from the S.U.N.Y. Health Sciences Center at Brooklyn and his MPH from the Johns Hopkins Bloomberg School of Public Health. Dr. Beyrer has worked as a staff epidemiologist at the Pan American Health Organization, Expanded Programme on Immunization (EPI) in Jamaica, Trinidad & Tobago; as a visiting researcher at NIH, NIAID, Division of Microbiology and Infectious Diseases; and as a study physician in the Center for Native American Health of Johns Hopkins University in Whiteriver, AZ. Currently, Dr. Beyrer is the director of the JHU Fogarty AIDS International Training and Research Program and the JHU Fogarty Tuberculosis International Training and Research Program. He is also the senior scientific liaison for Asia and Africa, HIV Vaccine Trials Network. |
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Ami Shah Brown, PhD, MPH Regulatory Affairs Manager, Johns Hopkins Bloomberg School of Public Health Ami Shah Brown received her PhD in the Department of International Health at Johns Hopkins Bloomberg School of Public Health and is currently heading the Regulatory Affairs Division for the Sabin Vaccine Institute's Human Hookworm Vaccine Initiative. She has a master of public health degree from The Rollins School of Public Health of Emory University with a focus in behavioral sciences and health education and BA in biology from the University of Pennsylvania. Before joining the Sabin Vaccine Institute, Dr. Brown worked as a senior research program coordinator in the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health. Other experience includes laboratory and community work on various HIV vaccine trials, a fellowship with the Centers for Disease Control and Prevention's (CDC) National Centers for HIV, STD, and TB prevention (NCHSTP) to develop measures for behavioral surveillance, and with the Emory Vaccines Center, where she designed the community education and recruitment plan for HIV vaccine trials. |
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Donald S. Burke, MD Professor, Johns Hopkins Bloomberg School of Public Health Donald A. Burke is professor of international health and epidemiology and director of the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health. Dr. Burke received his BA from Western Reserve University in 1967 and his MD from Harvard Medical School in 1971. His post-graduate medical training was in internal medicine at the Boston City Hospital and the Massachusetts General Hospital, and in infectious diseases at the Walter Reed Army Medical Center. Dr. Burke served on active duty in the U.S. Army Medical Research and Development Command for 23 years. He held assignments at the US Army Medical Research Institute of Infectious Diseases in Frederick Maryland (197375) at the Armed Forces Research Institute of Infectious Diseases in Bangkok, Thailand (197884) and at the Walter Reed Army Institute of Research in Washington, D.C. (197678 and 198497). Throughout his career, he developed new methods to prevent and control viral infections of global importance, focusing on tropical infections such as dengue, Japanese encephalitis, hepatitis A, and HIV/AIDS. He has conducted basic laboratory research, epidemiological research, clinical vaccine studies, and field vaccine trials. He has worked in high-containment facilities and in remote tropical research stations, and he has personally volunteered as a research subject in several vaccine trials. He joined the Johns Hopkins faculty in 1997. Dr. Burke has served on numerous advisory boards and councils for NIH, CDC, WHO, and other national and international agencies. He has published over 200 articles and chapters in medical and scientific journals. He was instrumental in founding the Civil-Military Alliance Against HIV/AIDS, and the International AIDS Vaccine Initiative. He is a past president of the American Society of Tropical Medicine and Hygiene, a fellow of the American College of Physicians, and a fellow of the Infectious Diseases Society of America. |
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Roberta (Bobbie) Casey, BS, MS Research Associate, Johns Hopkins Bloomberg School of Public Health Roberta Casey earned a bachelor of science in nursing from the University of Maryland and a master of science in nursing from Catholic University of America. After completing the program, Mrs. Casey was certified as a pediatric nurse practitioner. From 1984 to the present, Mrs. Casey has worked with the faculty and staff of the Center for Immunization Research and followed a cohort of patients in the Harriet Lane Clinic at the Johns Hopkins Hospital. She also functioned as the RSV pediatric program coordinator for the Center for Immunization Research, working closely with the principal investigator, Dr. Ruth Karron, on multiple vaccine protocols. In June, 2000, she was appointed as a research associate in the Department of International Health, Division of Disease Control, of the Bloomberg School of Public Health. Her current role involves coordination of all aspects of pediatric vaccine research trials at the Center for Immunization Research. A few important aspects of this position include the following: Education of investigators and staff in the conduct of vaccine clinical trials; IRB submissions; development of study-specific educational, recruitment, and data-collection tools; medical evaluation of pediatric vaccine volunteers; clinical trial management; and supervision of clinical staff. She is also principal investigator of a protocol "Antibody Screening of Potential Participants in Studies to Evaluate New Vaccines, Antimicrobial Agents, and Infectious Agents." Other research interests include informed consent and ethics in the research setting. |
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Nedra Davis, BS Community Education/Recruitment Assistant, Johns Hopkins Bloomberg School of Public Health Nedra Davis is currently the Community Education/Recruitment Assistant for the Johns Hopkins University HIV Vaccine Trial Unit (HVTU). She is part of a team which is responsible for educating and creating awareness in the Baltimore and DC area about preventive HIV vaccine clinical trials. Previously, she was involved in educating individuals on the issues of reproductive health and HIV/AIDS. She earned a bachelors of science degree at Towson University in health science with a concentration in community health education. |
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Anna Durbin, MD Assistant Professor, Johns Hopkins Bloomberg School of Public Health Anna Durbin is an assistant professor in the Division of Disease Control, Department of International Health, in the Bloomberg School of Public Health. She has a joint appointment in the Department of Medicine in the Johns Hopkins School of Medicine. Dr. Durbin received her BS from the University of Michigan in 1983 and her MD from Wayne State University in 1987. Her postgraduate medical training was in internal medicine and infectious diseases at the Detroit Medical Center, Wayne State University. From 19941999, she was a clinical fellow in the Respiratory Viruses Section of the NIAID/NIH, where she used recombinant DNA technology to design and recover novel live attenuated parainfluenza virus vaccine candidates. Dr. Durbin joined the faculty of the Johns Hopkins Bloomberg School of Public Health in 1999. At the Center for Immunization Research, she has been the principal investigator for Phase I and II trials of live attenuated dengue virus vaccine candidates. She is the clinical director of the Inpatient Isolation Unit located on the Bayview Medical Campus. Dr. Durbin also has experience in conducting challenge studies of enteric pathogens in collaboration with the Vaccine Testing Unit at the Johns Hopkins Bloomberg School of Public Health. |
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Paul W. Goebel, Jr. Vice President, Chesapeake Research Review, Inc. Prior to joining Chesapeake Research Review, Paul Goebel served in key human subject protection roles in the federal government for over 25 years with both the Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA). Until March, 2001, Mr. Goebel was the Senior Education Coordinator, Division of Education, OHRP, Department of Health and Human Services. This is the former Office for Protection from Research Risks, which was part of NIH. Mr. Goebel was the chair of FDA's IRB and editor of the 1998 update of the FDA Information Sheets for Institutional Review Boards and Clinical Investigators, a key resource supplementing the regulations; in addition to co-authoring a chapter in Expediting Drug and Biologics DevelopmentA Strategic Approach. He also served as coordinator of FDA policy for protection of human subjects of research. Earlier positions at FDA included directing the Radioactive Drug Research Committee programs for the Center for Drugs and the bioresearch monitoring program for the Bureau of Biologics; serving as a compliance officer in the Division of Drug Manufacturing; and working as an analytical chemist in the Kansas City District laboratory. Mr. Goebel was presented with the FDA Award of Merit as well as the Hammer Award and he is also a frequent presenter at government and industry national and regional forums. |
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Neal A. Halsey, MD Professor, Department of International Health, Johns Hopkins Bloomberg School of Public Health Neal A. Halsey is a professor of the Department of International Health, in the Bloomberg School of Public Health. He has a joint appointment in the department of pediatrics in the Johns Hopkins University School of Medicine. Dr. Halsey received his medical degree from the University of Wisconsin Center for Health Sciences in Madison. Following his internship, he completed a residency in pediatrics and a fellowship in pediatric infectious diseases at the University of Colorado in Denver. He is board certified in pediatrics and pediatric infectious diseases. Dr. Halsey has served with the Indian Health Service at Fort Yates, North Dakota, and as medical epidemiologist and chief of surveillance activities for the immunization division at the Centers for Disease Control and Prevention in Atlanta. He also has been a faculty member in the departments of Pediatrics and Tropical Medicine at Tulane University, New Orleans. Dr. Halsey has authored or co-authored more than 200 publications on the prevention and treatment of infectious diseases. His research interests have focused on vaccine-preventable diseases. He served for seven years with the research and development group for the World Health Organization's Expanded Programme on Immunization. He has been a member or liaison member of the Advisory Committee for Immunization Practices (ACIP) for eight years, and he served on the Committee of Infectious Diseases (The Red Book Committee) for ten years. |
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Clayton D. Harro, MD, ScM Assistant Scientist, Johns Hopkins Bloomberg School of Public Health Clayton Harro is an assistant scientist in the Department of International Health in the Johns Hopkins Bloomberg School of Public Health. Dr. Harro is board certified in internal medicine and received a master of science degree in vaccine development, evaluation, and policy at Johns Hopkins in 1996. His thesis focused on DNA vaccines and included a protocol design for an outpatient vaccination/inpatient challenge study of an investigational DNA influenza vaccine. Since joining the Johns Hopkins University Center for Immunization Research (CIR) in 1996, Dr. Harro has been principal investigator (PI) on industry-sponsored studies of DNA influenza vaccines, hepatitis B vaccines with MF59, and hepatitis B vaccines with GM-CSF. He has also served as medical director of the Johns Hopkins AIDS Vaccine Evaluation Unit. In this capacity, he has been the site PI on all preventive AIDS vaccine studies at the CIR and has actively participated in the design, conduct, and medical oversight of Phase I, II, and III trials of recombinant subunit vaccines, and Phase I/II trials of vector-based vaccines using vaccinia, canarypox, and attenuated S. typhi. In addition, Dr. Harro has collaborated with the National Cancer Institute (NCI) to develop a vaccine to prevent cervical cancer. He designed and was PI on the first-ever Phase I and Phase II human papillomavirus (HPV) type 16 virus-like particle (VLP) vaccine trials. He is a consultant to the NCI for upcoming Phase III trials of HPV 16 VLP vaccines in Costa Rica. |
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Hye Y. Kim, RPh Investigational Drug Pharmacist Hye Kim graduated from the University of Maryland, College Park, with a Bachelor of Science in Chemistry and from UMAB with a Bachelor of Science in Pharmacy. She has served at the Johns Hopkins Hospital as a Pharmacist from 1993 to the present. She is the primary investigational pharmacist for the HIV vaccine trials conducted at Johns Hopkins as well as other vaccine trials. |
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Vivian Rexroad, PharmD Research Pharmacist, Investigational Drug Service Vivian graduated from the University of Maryland School of Pharmacy in 1980 with a Bachelor of Science degree in Pharmacy and in 1998 with a Doctorate in Pharmacy. Vivian is a research pharmacist in the Investigational Drug Service. Her professional interests include international health and infectious diseases with a primary focus in HIV prevention and treatment. Vivian sets up research pharmacies, implements and monitors studies in India, Ethiopia, Uganda and Malawi. Vivian is the Pharmacy and Therapeutics reviewer and voting member for the investigational review boards at the Bloomberg School of Public Health. |
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Theron Scott Community Education/Recruitment Coordinator, Johns Hopkins Bloomberg School of Public Health Theron Scott is a lifelong resident of Baltimore, Maryland. He attended Towson State University, where he majored in business administration. In 1993, family and personal circumstances led him to the HIV/AIDS field. He has worked as an HIV counselor, educator, and outreach worker at Bon Secours Health Systems and New Hope Treatment Center in Baltimore. He has worked at the Johns Hopkins HIV Vaccine Trials Unit since 1999 and is currently charged with raising the level of awareness and education regarding HIV-prevention vaccines in communities throughout the Baltimore/Washington metro areas. In the words of Mr. Scott, "Being part of a international team that is working towards the development of a safe, effective, accessible HIV prevention vaccine far surpasses any of my prior goals." |
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Elizabeth Schappell, RN, BSN, CCRP Clinical Research Program Coordinator, Johns Hopkins Bloomberg School of Public Health Elizabeth (Betty) Schappell is a clinical research program coordinator at the Center for Immunization Research and a co-investigator for pediatric vaccine trials. An RN since 1993, she received a BS in nursing in 2005. She also received research certification through the Society of Clinical Research Associates in 2002. Betty has been involved in Phase I and II pediatric respiratory vaccine studies since 1998 and Phase I adult inpatient avian flu trials in 2005. However, her heart belongs to pediatrics, and she is returning to pediatric trials. |
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| Co-Author | ||
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Mary Jane Reynolds, RN, CS, MSN, FNP Nurse Consultant, National Institutes of Health (NIH) Mary Jane Reynolds is a nurse consultant for the National Institutes of Health (NIH), Division of AIDS with the Vaccine and Prevention Research Program, Vaccine Clinical Research Branch. She is an associate faculty member of the Johns Hopkins Bloomberg School of Public Health in the International Health Department. Ms. Reynolds received a master of science in nursing from Georgetown University, and she is a certified family nurse practitioner (FNP). Prior to accepting her appointment at NIH, she was the director of Clinical Trials Operations at the JHU Center for Immunization Research (CIR). In this position, she was responsible for the coordination and conduct of clinical vaccine trials at CIR. Ms. Reynolds was involved in all aspects of trial conductespecially protocol and consent form development, pre-study evaluation of vaccine trial participants, and adverse event evaluation. She was principal investigator for a long-term follow-up protocol for vaccine volunteers and a sub-investigator on all CIR protocols. Her clinical trial experience involved a variety of Phase I to Phase III trials in inpatient and outpatient settings to evaluate vaccines such as preventive HIV/AIDS; hepatitis A, B, and C; human papilloma virus; influenza; respiratory syncytial virus; parainfluenza; rotavirus; and dengue. Because training JHU and non-JHU faculty, principal investigators, and staff became an integral part of their work, Mary Jane Reynolds and Karen Charron set a goal in 1998 to design an educational program to standardize the training process. As a result of this goal, Ms. Reynolds and Ms. Charron co-authored and co-developed the Clinical Vaccine Trials: Planning and Implementation course. Ms. Reynolds remains a major contributor to the lectures in the current offering of this course. |
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| Co-Developers | ||
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Kathy Gilmore Campbell Kathy Gilmore is a graduate of Johns Hopkins University. Ms. Gilmore worked as a student assistant at the Center for Immunization research from 1999-2000. During this period, she helped recruit and screen volunteers for a human papilloma virus vaccine trial. In May, 2000, she began working with the development team of Clinical Vaccine Trials. Ms. Gilmore provided essential production and design support for a large portion of lectures and materials of Clinical Vaccine Trials. Post graduation, she currently worked as a research assistant at the Department of Defense Center for Deployment Health Research at the Naval Health Research Center in San Diego, C, coordinating epidemiological studies to investigate the health experiences of military personnel and their families. |
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Eugene V. Millar, PhD Research Associate, Center for American Indian Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health Eugene Millar is a research associate in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health. He received an MS in bacteriology from the University of Wisconsin-Madison (1995), and an MHS in infectious disease epidemiology from the Department of Epidemiology (2000) and a PhD from the Department of International Health (2003) at the Johns Hopkins Bloomberg School of Public Health. Dr. Millar's research interests are in the epidemiology of vaccine-preventable diseases of childhood, particularly among Native American populations. His doctoral dissertation evaluated the natural history of pneumococcal colonization, as well as the impact of pneumococcal conjugate vaccines on colonization, among Navajo and White Mountain Apache children. He also completed an internship in the Child Vaccine-Preventable Diseases Branch of the National Immunization Program, Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, and has served as a technical advisor to the World Health Organization (WHO) in Geneva, Switzerland. Dr. Millar was a co-developer of the content and format of Clinical Vaccine Trials. His hard work, creativity, and skills were instrumental in producing the quality lectures and materials presented in this course. |
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© 2009 The Johns Hopkins University. All rights reserved.
Copyright to this collective work of materials is owned by The Johns Hopkins University.
Copyright to individual contributions may be retained by contributing authors.