Clinical Vaccine Trials and Good Clinical Practice (GCP)  is offered by the Center for Immunization Research (Department of International Health, Division of Disease Control) and the Distance Education Division at the Johns Hopkins Bloomberg School of Public Health.

This course provides you with the background and tools needed to implement a Phase I or Phase II vaccine trial in a healthy population.

Prerequisite: Before enrolling in Clinical Vaccine Trials and Good Clinical Practice (GCP), you must have successfully completed Introduction to Online Learning (550.002.81), offered by the Distance Education Division. For more information and to register go to http://distance.jhsph.edu/oll

Please note that Clinical Vaccine Trials and Good Clinical Practice (GCP) is not open to undergraduate students.

Time Commitment: The most recent student course evaluations indicate that:

• 77% spent 15 or less hours on the course per week
• 19% spent 16 or more hours

After completion of this course, you should be able to do the following:

• 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
• Human papilloma virus (HPV)
• Malaria
• 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 Sasisopin Kiertiburanakul, MD vactrial@jhsph.edu

Please obtain the following:

1. Book B1 FDA Good CLinical Practice 2008 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, 2008, version of Book B1. The April 2009 version will not be available until mid April, which is too late for the course needs. The FDA reserves the right to make changes and updates to all regulations annually (March 31 each year). There are very few changes to sections pertaining to clinical research this year. There are no changes that affect the conduct of this course. We will post a document with the changed language on the online library for your convenience, but purchase the April, 2008, book now. Order from: www.clinicalresearchresources.com/books/bookstore.html
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.

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 TAs 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.