Clinical Vaccine Trials and Good Clinical Practice (GCP)

Primary Instructor
		Karen R. Charron, BSN, MPH Instructor Department of International Health, Johns Hopkins Bloomberg School of Public Health Karen Charron is an Instructor and Assistant Director of Academic Programs of the Global Disease Epidemiology Control program in the Department of International Health at the Bloomberg School of Public Health. She earned a bachelor of science in nursing degree from Towson State University in 1985 and completed her MPH degree at JHSPH in 1991. Ms. Charron is a vaccine trials expert who has been involved in the management and conduct of clinical trials of experimental vaccines with the Johns Hopkins University Center for Immunization Research (CIR) since 1992. She has served as co-investigator for numerous Phase I/II adult and pediatric vaccine trials of hepatitis B vaccines, preventive and therapeutic HIV vaccines, respiratory syncytial virus vaccines, rotavirus vaccines, and influenza virus vaccines. From mid 1997-99, Ms. Charron served as clinical research coordinator (CRC) for Abt Associates, Inc., the Domestic Master Contractor for the HIV Network for Prevention Trials (HIVNET). As the CRC, she was responsible for the clinical and operational oversight of a multicenter Phase II AIDS vaccine trial through HIVNET. She also coordinated and provided training for domestic and international investigators and staff, and monitored study conduct at eleven domestic vaccine trial sites. Since 2001, Ms Charron has directed a Clinical Vaccine Trials Training Program providing novel GCP training workshops in the US, Africa, Asia and Europe. Ms. Charron's research interests include vaccine evaluation, informed consent procedures, and injection drug user participation in clinical trials, and the conduct of vaccine trials according to the standards of Good Clinical Practice (GCP). She continues to pursue these interests through active collaborations with the National Institutes of Health (NIH) and the pharmaceutical industry.
Co-Instructor
		Amber Bickford Cox, MPH, CCRC Senior Research Program Coordinator for the Center for Immunization Research (CIR) Amber Bickford Cox is a Sr. Research Program Coordinator for the Center for Immunization Research (CIR). After studying African History in Pietermaritzburg, South Africa, Amber graduated from Smith College with a Bachelors degree in African History in 2000. Amber received a Master of Public Health in 2004 from Tulane University School of Public Health and Tropical Medicine with a concentration in International Health and Development/Complex Emergency Situations. Amber worked in South Africa in 2002 with the US Peace Corps designing and implementing trainings with local non-governmental organizations to reduce HIV transmission. She also has experience working as a reproductive and contraceptive health counselor in the United States. At the Center for Immunization Research, Amber currently is coordinating a Phase II HIV vaccine study and recently completed a first-in-man Staphylococcus aureus vaccine study. She also acts as the Project Coordinator for a Clinical Vaccine Trials Training Program providing novel GCP training workshops in the US, Africa, Asia and Europe.
Teaching Assistant
		Sasisopin Kiertiburanakul, MD MHS Student Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health Sasisopin Kiertiburanakul, MD is a second-year MHS student in the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health, where she is concentrating in infectious diseases epidemiology. Her master’s thesis is regarding pneumonia in HIV/AIDS patients. She also is an assistant professor of medicine at Division of Infectious Diseases, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Dr. Kiertiburanakul has worked in the infectious disease field for nearly 10 years. Her research area mainly focuses on infectious diseases especially HIV/AIDS. She has experience conducting infectious disease research involving many international multi-center studies and more than 40 publications are in Medline. She is also a committee member and/or consultant of various Thai national organizations, for example, Ministry of Public Health and National Health Insurance.
Guest Faculty
		Roberta (Bobbie) Casey, BSN, MSN, CRNP, CCRP 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. Mrs. Casey is also a certified registered nurse practitioner (CRNP) and a SOCRA-certified clinical research professional (CCRP). 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.
		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 1994-1999, 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.
		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 Development: A 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.
		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.
		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 and the director of operations at the Center for Immunization Research (CIR). 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. Dr. Harro was also a consultant to the NCI for Phase III trials of HPV 16 VLP vaccines in Costa Rica. As an ACRP certified physician investigator, Dr. Harro has strong interests in the principles of clinical trial conduct and operations and their application in developing country settings. Since 2001, he has co-directed a Clinical Vaccine Trials Training Program providing novel GCP training workshops in the US, Africa, Asia and Europe.
		Hye Y. Kim, RPh Investigational Drug Pharmacist Johns Hopkins Hospital, Investigational Drug Service 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 1991 to the present. She is the primary investigational pharmacist for the HIV vaccine trials conducted at Johns Hopkins as well as other vaccine trials.
		Lawrence H. Moulton , PhD, MS Professor International Health, The Johns Hopkins Bloomberg School of Public Health Dr. Moulton received an MS in 1978 from U. Texas SPH and his PhD in 1987 at the Johns Hopkins Bloomberg School of Public Health. He holds joint appointments in International Health and Biostatistics. His current research involves two themes: 1) analyses of data with "excess zeros" and 2) the design and analysis of group-randomized trials. The former includes data that have been left censored due to detection limits or naturally have a large proportion of recorded zeros. As for the latter, he is involved in several group-randomized trials; those involving vaccines are especially interesting, as they afford the opportunity to measure indirect effects of immunization. He is working on methods for the design, especially the randomization, of such trials, as well as methods of analysis of the resulting correlated data.
		Vivian Rexroad, PharmD Research Pharmacist Johns Hopkins Hospital 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 China, 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.
		Elizabeth Schappell, RN, BSN, CCRP Senior Research Nurse Johns Hopkins Bloomberg School of Public Health Elizabeth (Betty) Schappell is a senior research nurse 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 and 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 a Phase I adult inpatient avian flu trial in 2005.
		James R. Williams Associate Director, Johns Hopkins Bloomberg School of Public Health, Center for Communications Programs (CCP) Mr. Williams joined the Johns Hopkins University Center for Communications Programs (CCP) in January 1991 as an Associate Director and member of the faculty in the Bloomberg School of Public Health. He has more than 25 years of marketing and advertising experience having worked for four of the largest international advertising agencies in New York, Chicago and Washington, DC, where he was E.V.P and General Manager of DDB Needham. His experience includes marketing of products for Proctor & Gamble, McDonalds, General Foods, General Mills, Nabisco and Bristol-Myers. Mr. Williams also has expertise and experience in social marketing communications, both domestic and international. He has worked on social marketing programs in India, Indonesia, Ghana, among other countries. He has conducted seminars in many of these countries in communication strategy development, message design, creative materials development and social marketing. Mr. Williams has contributed to the strategic design of CCP communication projects in over 38 countries worldwide. He currently manages several domestic multi-faceted mass media and community outreach programs including: “The Red Ribbon Question Mark Campaign” to promote testing for HIV for the CDC/Maryland AIDS Administration and the NIH-funded “Project SAVE” for the Hopkins Center for Immunization Research. Mr. Williams has served as President of various organizations such as the Advertising Association of Baltimore, Planned Parenthood of Maryland and The Children’s Oncology Society. He has also received numerous awards including: the Martin Luther King Award for public service from the Johns Hopkins University, the Medal of Honor from the National Population Council of Egypt and an EMMY award for a documentary he co-produced on the AIDS epidemic in Baltimore.
		Eric Zimmerman, BS, RN, CCRC Research Program Coordinator Johns Hopkins Bloomberg School of Public Health Eric Zimmerman was a Sr. Research Program Coordinator at the Center for Immunization Research and a Co-Investigator for the HIV Vaccine Trials Unit. An R.N. since 1975, he received a BS in business administration in 1981 and clinical research certification thru the Assoc. of Clinical Research Professionals in 2001. He has been involved in HIV vaccine trials conduct and in training of US and international investigators and staff since 1992. He served on the NIH Division of AIDS HIV Vaccine Trials Network International (HVTN) Site Preparation Teams for South African and Thai HIV vaccine sites. With interests outside of the clinic as well, Eric supported development of the JHU community outreach and education projects and the HIV Vaccine Community Groups (CABs) in Baltimore and Washington D.C.

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