AÅžI613 - NON-CLINICAL TOXICITY STUDIES ON VACCINES and TOXI

Course Name Code Semester Theory
(hours/week)		 Application
(hours/week)		 Credit ECTS
NON-CLINICAL TOXICITY STUDIES ON VACCINES and TOXI AÅžI613 1st Semester 2 0 2 8
PrequisitesNone
Course languageTurkish
Course typeElective 
Mode of DeliveryFace-to-Face 
Learning and teaching strategiesLecture
Discussion
 
Instructor (s)Assoc Prof. Dr. Pınar ErkekoÄŸlu Prof.Dr. A. Fliz Öner Assoc Prof. Dr. Emirhan Nemutlu  
Course objectiveThe objective of this course is to give information to students on the non-clinical studies performed on vaccines, give knowledge on the ingredients present in vaccines and inform the students on the different toxicity tests performed for vaccines. 
Learning outcomes
  1. In this course, there will be a general introduction for the toxic effects of vaccines; consequently the toxic effects of preservatives, other adjuvants and ingredients will be discussed; the importance of non-clinical tests and the crucial points while performing these tests will be stated; information on the acute (single dose), subacute, subchronic and chronic (repeated dose) toxicity tests, reproductive toxicity and developmental toxicity tests performed on vaccines will be given; local toxi
Course ContentThe students will gain knowledge on the following at the end of this course:
I. the toxicity of the ingredients in the vaccines
II. all studies other than clinical studies performed on vaccines
 
References1. Casarett & Doull's Toxicology: The Basic Science of Poisons, Eighth Edition
2. The Vaccine Book Second edition 2016. (Barry R. Bloom and Paul-Henri Lambert, 2016).
3. Vaccine Excipient & Media Summary. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
4. WHO Guidelines on Nonclinical Evaluation of Vaccines, WHO, Geneva, Switzerland (2003).
5. EMEA. (2010). Guideline on repeated dose toxicity, CPMP/SWP/1042/99 Rev 1 Corr*
6. WHO guidelines on nonclinical evaluation of vaccines. WHO Technical Report Series, No. 927, 2005. http://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX%201Nonclinical.P31-63.pdf?ua=1
7. WHO Guidelines. Annex 2. Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccineshttp://www.who.int/biologicals/areas/vaccines/TRS_987_Annex2.pdf?ua=1
 

Course outline weekly

WeeksTopics
Week 1A general overview on the toxic effects of vaccines.
Week 2The possible toxic effects of preservatives in vaccines: Thimerosal and formaldehyde
Week 3Toxic effects of adjuvants and other compounds in vaccines: Aluminum and antibiotics (streptomycin, amphotericin B, etc.)
Week 4Toxic effects of adjuvants and other compounds in vaccines: monosodium glutamate, polysorbate 20, polysorbate 80, peanut oil, genetically modified organisms (GMOs)
Week 5Toxic effects of adjuvants and other compounds in vaccines: Egg proteins, squalene, gelatin, sorbitol, residual MRC5 proteins
Week 6The importance of non-clinical tests on vaccines and the points that should be notes while conducting these tests
Week 7Acute (single dose) toxicity tests on vaccines
Week 8chronic (repeated dose) toxicity tests on vaccines
Week 9Reproductive and developmental toxicity tests on vaccines
Week 10Local toxicity tests on vaccines
Week 11Vaccines and immunotoxicity
Week 12Vaccines and genotoxicity, carcinogenicity and teratogenicity tests
Week 13Seminar, Discussion
Week 14Seminar, Discussion
Week 15Preparation for Final Exam
Week 16Final exam

Assesment methods

Course activitiesNumberPercentage
Attendance1410
Laboratory00
Application00
Field activities00
Specific practical training00
Assignments00
Presentation110
Project00
Seminar110
Midterms120
Final exam150
Total100
Percentage of semester activities contributing grade succes150
Percentage of final exam contributing grade succes150
Total100

WORKLOAD AND ECTS CALCULATION

Activities Number Duration (hour) Total Work Load
Course Duration (x14) 14 2 28
Laboratory 0 0 0
Application000
Specific practical training000
Field activities000
Study Hours Out of Class (Preliminary work, reinforcement, ect)1010100
Presentation / Seminar Preparation11010
Project000
Homework assignment12020
Midterms (Study duration)11515
Final Exam (Study duration) 14040
Total Workload2897213

Matrix Of The Course Learning Outcomes Versus Program Outcomes

D.9. Key Learning OutcomesContrubition level*
12345
1. Has knowledge of research methods and statistical methods used in the vaccinology and has knowledge about comparing existing studies and evaluating their limitations, accuracy, validity and reliability    X
2. Has knowledge on ethical principles with respect to all kinds of scientific and professional work in the area of vaccinology, and acts accordingly. X   
3. Using the knowledge and the skills he/she gained, detects existing vaccination problems in communities, produces recommendations by developing policies and strategies, and shares the information, takes part in a team work  X   
4. Can gather information about the safety of vaccine,    X
5. Comprehends, assesses, and interprets interdisciplinary interaction in vaccinology. X   
6. Can design and apply an experimental setup in a laboratory environment and can analyze the obtained data.    X
7. Know the principles of good laboratory practice and good clinical practice.    X
8. Knows which type of study to conduct in acute conditions, providing required evidence for appropriate interventions and takes part in the process for effective and quick solutions X   
9. Evaluates the international developments in the vaccinology independently regarding conditions,   X 
10. Contributes to health policy studiesX    
11. Conducts scientific research, writes and presents scientific papers on vaccinology.    X
12. Evaluate quantitative and qualitative techniques in health economics and pharmacoeconomicsX    

*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest