Syllabus: Spring 2017 Vaccine Epidemiology 1- Jennifer S. Smith, Ph.D., MPH

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1 Syllabus: Spring 2017 Vaccine 1- Jennifer S. Smith, Ph.D., MPH Course: EPID Vaccine, EPID 760 Instructor: Dr. Jennifer Smith Cell When: January 22 - April 23, Spring 2018 Where: Gillings School of Global Public, MCG 2306 Class Day and Time: Mondays 3:35 6:35 PM Credits: 3 credits Course Description: The UNC Department of s Vaccine course will include an overview of vaccinology principles, mechanisms of action, and herd protection. Students will obtain an in-depth understanding of how vaccines are produced by industry, undergo preclinical evaluation, and evaluated for efficacy in clinical trials. For public health programs, the global implementation of immunization programs will be covered, including measles eradication and how to best optimize population acceptability of vaccination. Course teaching will include a combination of didactic lectures, in-depth discussions on selected publications, and a final course research project individually developed by the student. Focus will be on global as well as domestic perspectives of vaccination for public health. Desired Course Outcomes: To understand differences in vaccines in terms of their production and their modes of prevention To gain an in-depth understanding of the array of public health disciplines related to vaccination To understand the basic underlying principles of vaccine immunology and approaches to evaluate the clinical impact of vaccination To learn to formulate research questions and lead a class discussion on a chosen article related to vaccination. To be able to formulate a research question and short proposal on vaccination using a randomized clinical trial design in order to address an important public health problem Class schedule: Week Date Class Topic Speaker Speaker Presentation and Q&A 3:35 5:00 PM Dr. Jennifer Smith will lead Class Discussion 5:20 6:35 PM 1 January 22 Overview of Vaccinology What is the ideal vaccine, is it an ideal disease to do a vaccine; why certain vaccines work -- to prevent infection, to prevent disease; herd protection, herd immunity David Weber UNC School of Medicine dweber@unch.unc.edu Each week, 1-2 student(s) will present one selected article of their choice which is related to the Class Topic, and lead the class discussion related to that article. Students will be assigned required articles for each class, and be expected to turn in their responses at the beginning of each class. During the class, students will be

2 Syllabus: Spring 2017 Vaccine 2- Jennifer S. Smith, Ph.D., MPH divided into two break-out groups for discussion, with feedback to the larger group. Dr. Smith will lead a discussion of key concepts, questions and class summary. 2 January 29 Immunological Principles for Vaccination 3 February 5 Vaccine Development and Efficacy, using HPV Vaccination as an Example from Laboratory Studies to Clinical Trials 4 February 12 Statistical Considerations for Vaccine Efficacy and Effectiveness Lola Stamm lstamm@ .unc.edu Jennifer Smith jennifers@unc.edu Michael Hudgens mhudgens@bios.unc.edu 5 February 19 Preclinical Vaccine Evaluation 6 February 26 Methods for Studying Vaccine Safety and Effectiveness in Care Data (request to include more methods discussion) 7 March 5 Systems for Monitoring Vaccine Safety in the United States Ralph Baric rbaric@ .unc.edu Alan Brookhart mabrook@ .unc.edu Emmanuel (Chip) Walter Duke University Professor of Pediatrics walte002@mc.duke.edu 8 March 19 Global Malaria Vaccination Steve Meshnick UNC School of Medicine Professor, meshnick@ .unc.edu

3 Syllabus: Spring 2017 Vaccine 3- Jennifer S. Smith, Ph.D., MPH 9 March 26 Herd Protection and Implementation of Vaccination Programs in Nicaragua Sylvia Becker-Dreps UNC Family Medicine sbd@ .unc.edu 10 April 2 Student Presentation Week 1 11 April 9 Student Presentation Week 2 12 April 16 Immunotherapy Potential of Vaccination 13 April 23 Future of Vaccines Where are we going for the future of vaccines? (ie. HIV, EBV, CMV, Ebola, vaccines; vaccines for non infectious diseases; targeting cancer; new delivery systems; adaptive trials; new adjuvants; new molecular methods for developing vaccines). Matthias Gromeier The Preston Robert Tisch Brain Tumor Center Duke Cancer Institute grome001@mc.duke.e du Narendra Chirmule Senior Vice President, Head, Research and Development, Biocon Research Laboratories narendra.chirmule@biocon.com Course Format Lecture discussions by experts in key global health including group discussions and videos. Student s responsibilities include timely completion of assigned readings and coursework plus active participation in small group discussions and activities. We encourage asking questions during class and also connecting with guest speakers. A twenty minute break is assigned between guest lecture sessions; and the second session on concepts led by Dr. Smith and the student lead paper discussion, to allow for networking. Class Readings and Homework: Students will be assigned 3-4 readings (either manuscripts or book chapters) each week during the course of the semester. Required readings will be chosen each week in relation to the class topic. One time during the semester, each student will be responsible to choose an article that interests them and is related to their assigned class topic, and prepare a series of questions on their chosen article to be given to the class as homework following review and approval by Dr. Smith. Each week, the students will be responsible for independently preparing written answers to the assigned questions. Written answers should be ed to the TA prior to the beginning of the class session. These will be evaluated only on the basis of completion (rather than content) and incorporated into your class participation grade. Unless otherwise indicated, all course readings and materials will be posted on the course Sakai site in the Course Documents section. For each student s article/questions presentation week: Class topics will be assigned before the first day of class (you will submit ranked preferences). Articles should be selected during the first week of class (these can be changed given enough prior notice).

4 Syllabus: Spring 2017 Vaccine 4- Jennifer S. Smith, Ph.D., MPH A draft of your questions should be submitted for review two weeks prior to your class date. Please add this date to your calendars to send on time. The final version of your questions should be sent out a week before your class date. Final class project: Each student will design and present their own vaccine trial. Trials can be varying, depending upon students interests (ie. Phase I, II, II or IV trials; behavioral intervention trial to increase vaccine uptake; comparison of two vaccines with immunological endpoints). This is intended to be a randomized controlled trial approval is required for alternate trial designs. Ideally, the project will be related to each student s research interest, and students may obtain feedback on their ideas throughout the semester. Students will submit a 1-2 page draft proposal for their project on the day of their practice oral presentation. This project proposal should contain the following sections: 1) Background; 2) Specific Aims; 3) Methods. Some example project proposals will be circulated to students two weeks before this draft proposal is due. On student presentation day, students will present their developed final class project as an oral presentation to their fellow classmates and attending faculty for input and suggestions. A mock slide set will be given to students two weeks prior to their presentation as a presentation guide. The final research project should be submitted as a report on the final day of the class. The final project should include the following elements: 1-3 Key Specific Aims; study hypotheses; study justification; key methods (including both exposure and outcome definitions), laboratory methods if applicable; key trial activities; analysis section; sample size calculations; a simplified timeline; and rough budget estimate for planning purposes. The entire report should not exceed five pages. Course Evaluation: Total Points Possible: 100 points Class participation 30 points (30%) Presentation of chosen article 20 points (20%) Class Assignments (Written responses to questions) 15 points (15%) Final Written Research Project 35 points (35%) EPID 760 Student Reading List Class 1: Overview of Vaccinology, David Weber 1. Plotkin, Stanley A, Orenstein, Walter A, Offit, Paul A. Vaccines: A Short History of Vaccination. Elsevier Saunders Pages Centers for Disease Control and Prevention. and Prevention of Vaccine-Preventable Diseases. Principles of Vaccination. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C. Public Foundation, Pages Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ. Methods for developing evidence-based recommendations by the ACIP of the CDC Vaccine 2011;29(49): Useful References: CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60(RR02): WHO. Global Vaccine Action Plan, Class 2: Immunological Principles for Vaccines, Lola Stamm 1. Plotkin, Stanley A, Orenstein, Walter A, Offit, Paul A. Vaccines: Vaccine Immunology. Elsevier Saunders Pages

5 Syllabus: Spring 2017 Vaccine 5- Jennifer S. Smith, Ph.D., MPH 2. Leo, Oberdan, Cunningham, Anthony, Stern Peter L. Understanding Modern Vaccines: Perspectives in Vaccinology. Science Direct :1, Class 3: Vaccine Development and Efficacy, using HPV Vaccination as an example from laboratory studies to clinical trials, Jennifer Smith 1. Plotkin, Stanley A, Orenstein, Walter A, Offit, Paul A. Vaccines: Human Papillomavirus Vaccine. Elsevier Saunders Pages Herrero R, González P, Markowitz LE. Present status of human papillomavirus vaccine development and implementation. Lancet Oncol May;16(5):e doi: /S (14) Review. PubMed PMID: Class 4: Statistical Considerations for Vaccine Efficacy and Effectiveness, Michael Hudgens 1. Hudgens MG. Endpoints in vaccine trials. Stats Methods Med Res Apr;13(2): PubMed PMID: Perez-Heydrich, C., Hudgens, M.G., Halloran, M.E., Clemens, J.D., Ali, M. and Emch, M.E., Assessing effects of cholera vaccination in the presence of interference. Biometrics, 70(3), pp Halloran, Elizabeth M et al. Study Design for Evaluating Difference Efficacy and Effectiveness Aspects of Vaccines. American Journal of Nov 15;146(10): PMID: Class 5: Preclinical Vaccine Evaluation, Ralph Baric 1. Richardson, Charles. Norovirus virus-like particle vaccines for the prevention of acute gastroenteritis. Vaccines (2), PMID: Lindesmith LC. Broad blockade antibody responses in human volunteers after immunization with a multivalent norovirus VLP candidate vaccine: immunological analyses from a phase I clinical trial. PLoS Med Mar 24;12(3):e doi: /journal.pmed ecollection 2015 Mar. PubMed PMID: ; PubMed Central PMCID: PMC Class 6: Methods for Studying Vaccine Safety and Effectiveness in Care Data, Alan Brookhart 1. McGrath, Leah J. Influenza Vaccine Effectiveness in Patients on Hemodialysis. Arch Intern Med Apr 9;172(7): PMID: Baker, Meghan, et al. A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program. Am J Epidemiol Apr 15;181(8): doi: /aje/kwu322. Class 7: Systems for Monitoring Vaccine Safety in the United States, Chip Walters 1. Leroy Z. Febrile seizures after influenza vaccine in young children, United States: A vaccine safety signal from the vaccine adverse event reporting system. Vaccine Mar 2;30(11): PMID: Tse A, Tseng HF, Greene SK, Vellozzi C, Lee GM; VSD Rapid Cycle Analysis Influenza Working Group. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, Vaccine Mar 2;30(11): doi: /j.vaccine Class 8: Global Malaria Vaccination, Steve Meshnick 1. Greenwood, Brian et al. Implementation of the malaria candidate vaccine RTS,S/AS01. The Lancet. Volume 387, Issue 10016, DOI: 2. Hoffman SL, Vekemans J, Richie TL, Duffy PE. The march toward malaria vaccines. Vaccine Nov 27; 33: Supplement 4: D PMID:

6 Syllabus: Spring 2017 Vaccine 6- Jennifer S. Smith, Ph.D., MPH Class 9: Herd Immunity and Implementation of Vaccination Programs in Nicaragua, Sylvia Becker- Dreps 1. Ali, Mohammad. Herd immunity conferred by killed oral cholera vaccines in Bangladesh: a reanalysis. Lancet Jul 2-8;366(9479):44-9.PMID: Panozzo, Catherine A. Direct, Indirect, Total, and Overall Effectiveness of the Rotavirus Vaccines for the Prevention of Gastroenteritis Hospitalizations in Privately Insured US Children, American Journal of Apr 1;179(7): PMID: Class 10: Student Presentation Week 1 Class 11: Student Presentation Week 2 Class 12: Immunotherapy Potential of Vaccination, Matthias Gromeier 1. Brown MC, Gromeier M. Cytotoxic and Immunogenic Mechanisms of Recombinant Oncolytic Poliovirus. Current Opinion in Virology Aug;13: PMID: De Vries, Jolanda J. Immunotherapy: Cancer vaccine triggers antiviral-type defenses. Nature 2016 June; 534, (7607): 329. Class 13: Future of Vaccines, Narendra Chirmule 1. Koff, Wayne C. Accelerating Next-Generation Vaccine Development for Global Disease Prevention. Science May 31;340(6136): PMID: Koff, Wayne C. Toward a human vaccines project. Nature Immunology Jul;15(7): PMID: