Vaccine Trials: Methods and Best Practices

This course will explore the process of evaluating investigational vaccines in clinical trials including informed consent, recruitment, enrollment, safety evaluation, and quality data collection.

About the Course

Vaccines are evaluated through a series of clearly defined controlled studies to assess these investigational products for safety, immunogenicity and efficacy before they are approved for licensure. All clinical vaccine trials are bound by international ethical guidelines and, in the case of US trials, Food and Drug Administration (FDA) regulations. Good Clinical Practice is defined by the International Conferences on Harmonization (ICH) as: “A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.” That’s a tall order, so how is it done? Individuals who enroll as subjects in these trials play an essential role in the development and evaluation of new and improved candidate vaccines. They are average citizens who volunteer to roll up their sleeves and, in the process, make a tremendous difference in society. So why do they volunteer and what safeguards do we put in place to protect their rights, safety and well-being while in the trial? What are the responsibilities of the investigators, sponsors and ethics committees who conduct and oversee these trials? Along with our colleagues, we will introduce you to how GCP is applied in clinical vaccine trials to ensure proper and ethical scientific conduct. The course will use examples from real vaccine trials to demonstrate the application of the FDA Code of Federal Regulations and ICH GCP Guidelines to explore methods and best practices involved in implementing phase I and II vaccine clinical trials. This short course offering through Coursera is based on our work at the Center for Immunization Research and an in-depth graduate course taught at the Johns Hopkins Bloomberg School of Public Health. We hope it inspires you to work in this exciting field.

About the Instructor(s)

Karen R. Charron, BSN, MPH, CCRChttp://distance.jhsph.edu/core/index.cfm/go/sb:about.course/cid/69/
Associate Lecturer
Center for Immunization Research
Faculty; Department of International Health, Johns Hopkins Bloomberg School of Public Health

Karen Charron is an Associate Lecturer 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. She is a Certified Clinical Research coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP).

Ms. Charron is a vaccine trials expert who has been involved in the clinical investigation, management and operational conduct for multiple phase I and II clinical trials of adult and pediatric experimental vaccines with the Johns Hopkins University Center for Immunization Research (CIR) since 1992. Vaccines studied include hepatitis B vaccines, preventive and therapeutic HIV vaccines, respiratory syncytial virus vaccines, rotavirus vaccines, human papilloma vaccine (HPV) and influenza virus vaccines. She currently is the Principal Investigator for the Center for Immunization Research healthy adult screening protocol. Ms. Charron served as clinical research coordinator (CRC) for Abt Associates, Inc., the Domestic Master Contractor for the HIV Network for Prevention Trials (HIVNET) responsible for the clinical and operational oversight and training for a multicenter Phase II AIDS vaccine trial. Ms. Charron is focused on training and education. She developed a graduate online course at JHSPH entitled Clinical Vaccine Trials and Good Clinical Practices (GCP) course offered every spring which provides GCP certification; developed and directed a program of applied face to face GCP training workshops in the US, Africa, Asia and Europe, directs a Master of Science in Public Health (MSPH) program in Global Disease Epidemiology and Control Program in the Department of International Health.

Amber Bickford Cox, MPH, CCRChttp://distance.jhsph.edu/core/index.cfm/go/sb:about.course/cid/69/
Research Associate
Center for Immunization Research
Program Manager, Johns Hopkins Vaccine Initiative
Faculty; Department of International Health Johns Hopkins Bloomberg School of Public Health

Amber Bickford Cox is a Research Associate with the Centers for Immunization Research (CIR). She is the co-instructor of JHSPH Clinical Vaccine Trials and Good Clinical Practices (GCP) course offered through the CIR and co-instructor for the JHSPH Vaccine Science and Policy Certificate and Special Topics in Vaccine Science Seminar. She has served as a Clinical Coordinator, Clinical Monitor and QA/QC Specialist. She also served as the Project Coordinator for the Clinical Vaccine Trials Training Program providing novel ICH GCP training workshops in the US, Africa, Asia and Europe.

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. Ms. Cox is a Certified Clinical Research coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP)

An Introduction by Ruth Karron, MD Professor Ruth Karron, MD
Director, Center for Immunization Research
Director, Johns Hopkins Vaccine Initiative
Johns Hopkins Bloomberg School of Public Health

Ruth A. Karron, M.D., is a Professor in the Department of International Health, Johns Hopkins Bloomberg School of Public Health, Director of the Center for Immunization Research, and Founding Director of the Johns Hopkins Vaccine Initiative. Dr. Karron is a pediatrician, trained in infectious diseases, who has extensive experience in the evaluation of respiratory virus vaccines (including vaccines for respiratory syncytial virus, parainfluenza viruses, avian influenza, and pandemic influenza) in adult and pediatric populations. Dr. Karron's research interests also include the pathogenesis of enhanced RSV disease, the development of immune responses to respiratory viral infections in early life, the epidemiology of RSV and other respiratory viral diseases in resource-poor settings, and public policy issues related to vaccine development and distribution. She has served on a number of national and international vaccine advisory committees and panels, and chaired the FDA's Vaccine and Related Biological Products Advisory Committee (VRBPAC) from 2006-2008. She is currently a member of the Advisory Committee on Immunization Practices (ACIP).

Course Syllabus

This course will cover the following topics: A brief review of vaccine history and types; how vaccine trials are conducted, including which data are collected and how those data are managed and evaluated; appropriate processes to ensure human subjects protection and informed consent; methods for recruitment and enrollment of participants; and vaccine safety assessment. Upon successfully completing this course, students will be able to:

• Describe the types of vaccines in use today
• Describe how vaccines are evaluated in phase I and II clinical trials
• Identify key regulatory requirements, considerations and ethical standards for human subjects protection and informed consent. 
• Discuss how clinical trials are conducted with an emphasis on quality data and protection of the rights, safety and well-being of volunteers.

Recommended Background

The pre-requisite for this class is a basic understanding of vaccines. For those without this background, the CDC Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink book) is an available resource providing information on routinely used vaccines and the diseases they prevent! http://www.cdc.gov/vaccines/pubs/pinkbook/index.html

A course on Vaccines is also taught by Paul Offit through Coursera which may be helpful to those enrolling in this course but is not required.

Course Format

The course will involve weekly lectures followed by a short assessment assignment.

FAQ

• Who should enroll in this course?

  The audience for this class includes: Those currently working in clinical trials, pre-clinical development, regulatory and ethical review of research Students of public health, medicine, nursing, and biological sciences

• Do I need a textbook for this course?

  All the material needed for this course can be found on the web or within the lectures. The course will reference the US Code of Federal Regulations 21 CFR 50, 56 and 312 and the ICH Standards of Good Clinical Practice E6. You can also find electronic versions on the web. USFDA and ICH GCP E6. For those with strong interest in this field, we recommend that you purchase a printed GCP reference book at www.clinicalresearchresources.com.

Provided by:

University: Johns Hopkins University

Instructor(s): Karen R. Charron, Amber Bickford Cox