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.

Upon completion of this course, you will be able to:

• Approach the vaccine trial process as a dynamic team effort conducted within ethical and regulatory guidelines
• Identify the primary objectives of a vaccine trial and explain how they are evaluated
• Describe the components required to conduct a successful clinical vaccine trial
• Explain the regulatory requirements and their application in clinical vaccine trials
• Identify key ethical issues in human subjects protection in clinical trials
• Identify key considerations in the development of an informed consent form
• Examine principles of community education and recruitment of vaccine trial volunteers
• Formulate clinical vaccine protocol documents
• Explain how vaccine development impacts public health
• Explain and apply the practical aspects of designing and enrolling a clinical trial

• The scientific method and vaccine trials
• Review of vaccine types
• Discussion of the phases of vaccine trials
• Vaccine protocol development
• Regulatory requirements
• Roles and responsibilities of investigators, sponsors, and staff
• Budget development
• Human subjects protection
• Data collection and management
• Community preparedness/outreach
• Recruitment
• Global partners and considerations in vaccine research
• Protocol implementation including screening, enrollment, follow-up, and study close-out

This is a three-credit course that runs for eight weeks. We have organized the course materials into seven modules and twelve lectures. You are expected to budget your time so that you complete the lectures and assignments in the appropriate time. Review the Course Content page for each assignment date and deadline. The course grading policy is outlined below. 

The course assignments are designed as practical exercises to help you understand the complexities of the conduct of vaccine trials and to help you deal with various issues or problems that may arise. They include:

• Group exercises
• Individual exercises
• Discussion/participation

Development of vaccine protocol: You will each be assigned to a global health issue to work on throughout the term:

• HIV
• Dengue
• ETEC (enterotoxigenic E. coli)
• Respiratory syncytial virus (RSV)

We will provide you with a sample protocol template for each global issue. You must refer to and amend this protocol to complete these assignments. In a group, you will create a protocol summary, inclusion and exclusion criteria, an educational brochure, and recruitment material. You will receive detailed instructions for each exercise. Individually, you will complete an Adverse Event Simulation, Informed Consent Form and a Final Open Book Exam.

Other required exercises: The remainder of the course grade will be based on

• Participation in LiveTalks 2, 3 and 4 (LiveTalk 1 optional)
• A peer evaluation

Late policy: We expect you to complete assignments on time. We can't issue grade reports until we receive all assignments. Therefore, to be fair to other students, we will penalize unapproved late submissions incrementally per day. If illness or special circumstances impact completing an assignment on time, students are required to contact the instructor or TA prior to the due date to discuss options.

*Completion of 5 out of 7 module quizzes

This course is graded on a strict point system as described below. Do not expect a curve.

Primary Instructor Karen Charron, RN, MPH kcharron@jhsph.edu, 443-287-2628 Co-Instructor Amber Bickford Cox, MPH acox@jhsph.edu Teaching Assistant Andrea Feller, MHS vactrial@jhsph.edu

Please obtain the following:

1. Book 1B FDA Good Clinical Practice 2009 Reference Guide: this book contains FDA Good Clinical Practice regulations (21 CFR Parts 11, 50, 54, 56, and 312) and ICH Guidelines (E6, E2A, and E8), as well as the FDA Information Sheets and other guidance documents that govern the conduct of clinical trials for drug research. Please purchase the April, 2009, version of Book 1B. 
2. You will view and download the reading materials for this course (in html or pdf format) online via the Welch Library's E-Reserve system. E-Reserve links will be provided on individual lecture pages. For international students who have difficulty downloading the files, contact us at vactrial@jhsph.edu.
3. Recommended Readings and Course Materials: You will view and download recommended readings and course materials, including protocol templates and instructions, from the online library.  

Each LiveTalk session will be offered once. If you are not able to attend a LiveTalk session, you must read/listen to the archive of the LiveTalk session and post a response to the BBS under the appropriate category "LiveTalk Makeup."

We recognize that there are students from across the globe taking this course. We ask that each of you be courteous and cooperative with time zone and other issues of your fellow classmates. Please be sure that everyone has an opportunity for input and actively participates in the group assignments. If there are significant problems, contact the TA or instructor at vactrial@jhsph.edu before due dates.

Feedback from students each year has greatly enhanced the course.

• An individual lecture evaluation is located on each lecture main page. Please complete it as you complete each lecture.
• An online evaluation form is available during the last week of the course.

We do listen. Student feedback has greatly shaped revisions to this course. Please take the time to give us yours.