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
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.
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.