223.662.01 Vaccine Development and Application
Instructors: Neal Halsey
Description: Reviews the processes used to evaluate all aspects of vaccine development and the use of immunizations for disease prevention. Emphasizes in-depth understanding of vaccines successfully introduced into routine immunization schedules. Discusses procedures and oversight at each step in the process, including post-licensure policy making and monitoring for safety and effectiveness. Full description Also offered online second term 223.662.81 223.687.01 Vaccine Policy Issues
Instructor: Daniel Salmon
Description: Examines current national and international policy issues in vaccine research, development, manufacturing, supply, and utilization. Topics include development of orphan vaccines, ensuring an adequate supply of safe and effective vaccines, vaccine injury compensation, and disease eradication. Emphasizes the identification of important vaccine policy issues and the development and evaluation of policies to address these issues. Presents the roles, responsibilities, and policy positions of key immunization stakeholders via guest lectures by a wide array of experts who have worked for important vaccine groups (i.e., FDA, GAVI, Vaccine Industry, US Vaccine Injury Compensation Program, Consumer Group). Readings include relevant scientific papers and reviews, and publications of U.S. and international agencies. Full description. 223.689.01 Biologic Basis of Vaccine Development
Instructors: Anna Durbin and Jay Bream
Description: Provides an overview of the biologic basis for development and evaluation of new viral, bacteriologic, parasitic, and cancer vaccines. Lectures address the fundamental immunologic concepts of correlates of protective immunity underlying current and new strategies for immunization. Emphasizes the use of new technologies for expression of vaccine antigens, including recombinant DNA techniques and use of novel adjuvants and antigen-carrier systems to enhance the delivery/presentation of specific immunogens to effector sites. Full description. 223.705.81 Clinical Vaccine Trials and Good Clinical Practice
Instructor: Karen Charron and Amber Bickford Cox
Description: Provides students with background and tools needed to implement Phase I and II clinical vaccine trials in a healthy population according to the standards of Good Clinical Practice (GCP). Addresses both FDA Code of Federal Regulations and ICH GCP Guidelines needed for domestic and international clinical trials. Includes the following topics: review of vaccine history and types; discussion of phases of vaccine trials; development and implementation of a vaccine protocol; GCP guidelines; roles and responsibilities of the investigator and designees; ethical review committees and sponsors; budget development; product management; human subjects protection; and data collection and management, recruitment, community outreach, and overall trial conduct. Full description. 223.867.01 Vaccine Seminar
Instructor: Anna Durbin and Amber Bickford Cox
Description: Series of seminars (4 per term) on vaccine research against infectious diseases of global importance including AIDS, tuberculosis, malaria, childhood illnesses, and many others. Economic, political, and ethical dimensions of vaccine R&D are also covered. Leading vaccine experts at JHU, from industry and other institutions present the seminars. Series provides the student with an understanding of the pathways leading to development and utilization of vaccines with public health impact. Full description. To find out more about the Vaccine Science and Policy Certificate Program click here. |
