Course Syllabus

Vaccine Development During a Pandemic:

Immunization has been one of the most important public health interventions of the 20th & 21st centuries. Our systems for vaccine development, delivery, monitoring and education are fragile and dynamic, and are not designed to rapidly produce a safe and effective vaccine during a pandemic event such as the current COVID-19 pandemic.

This interactive remote learning course is designed to introduce students to the basics of designing, developing, rapidly evaluating vaccine safety and efficacy, and distribution of a vaccine during a pandemic, using COVID-19 as an example.

Specific topics to be covered include:

The history of vaccines and vaccinology; an overview of coronavirus and the current pandemic; establishing medical need (i.e. how to think about and develop a target product profile for a candidate vaccine); vaccine makeup and development issues; safety and efficacy concerns and monitoring; and mobilization of production resources during a crisis situation.             

Course Overview:

Due to constraints imposed by social distancing mandates during the COVID-19 pandemic, the course will be conducted by interactive zoom conferencing during the Spring 2020 semester.

The class will be divided into teams of 3-4 students.

Each week, either or both Drs. Stanberry and LaRussa will introduce one of the topics described above with a lecture designed to give students a basis for thinking about how to design, develop and deploy a safe and effective COVID-19 vaccine in a timely manner. Recommended readings will also be suggested.

Each team will then have about one week to consider the topics presented in that week’s lecture(s) and to develop and justify their strategy for advancing their vaccine towards market.

Week 1 – each team will design their preferred vaccine construct.

Week 2 – each team will develop the target product profile for their vaccine construct.

Week 3 – each team will develop a Phase 2 clinical trial design for their vaccine.

Week 4 – each team will revise and present a final plan for their vaccine from concept to distribution and use including long term follow up studies.

After the team presentations, there will be a group discussion.

Goals & Objectives:

Students who successfully complete this course will be able to:

1.      Understand the key stages of vaccine development including establishing medical need, the different vaccine platforms and adjuvant systems, technical issues that can impact the speed of development, creating a target product profile.

2.      Appreciate the issues related to clinical trial design in assessing vaccine safety and efficacy including post-marketing surveillance.

3.      Become familiar with the unique challenges associated with vaccine clinical development and roll out in a crisis situation.

Suggested and Supplemental Readings:

Suggested and Supplemental Readings will be posted under Modules on Canvas.

Dates, Topics, Lecturers:

Date

Topics

Lecturer(s)

Monday, June 1st

History of Vaccines & Vaccinology 101
Coronavirus Overview
Establishing Medical Need

Philip LaRussa, MD and Lawrence Stanberry, MD, PhD

Tuesday, June 2nd

Vaccine Makeup and Development Issues
a. Live attenuated, killed, protein subunit, RNA or DNA?
b. Adjuvant?
c. Technical issues that can impact the speed of development

Lawrence Stanberry, MD, PhD

Following lecture 2, teams will design and develop justifications for their preferred vaccine construct

Tuesday, June 9th

Teams will present their vaccine design and justify the design

Students

Wednesday, June 10th

Develop a Target Product Profile (TTP)

Lawrence Stanberry, MD, PhD

Following lecture 3, teams will develop the TPP for their vaccine construct

Tuesday, June 16th

Teams will present and defend their TPP

Students

Wednesday, June 17th

Safety & Efficacy Testing

Philip LaRussa, MD

Following lecture 4, teams will develop a Phase 2 clinical trial design for their vaccine

Monday, June 22nd

Teams will present and defend their Phase 2 clinical trial design

Students

Tuesday, June 23rd

Vaccine clinical development in a crisis situation

Philip LaRussa, MD and Lawrence Stanberry, MD, PhD

Wednesday, June 24th

Vaccine rollout in a crisis situation

Philip LaRussa, MD and Lawrence Stanberry, MD, PhD

Following lectures 5 and 6, teams will incorporate what they learned in the two previous sessions and revise a final plan for their vaccine from concept to distribution and use including long term follow up studies.

Monday, June 29th and Tuesday, June 30th

Teams will present and defend their final plan for their vaccine from concept to distribution and use including long term follow up studies

Students