Describe the four clinical phases of vaccine testing pre-licensure and include the major objectives of each phase .

Section 1: Short Answer. Answer the following questions as completely and concisely. Most answers will be complete in two or three sentences.
Q1. What is considered by many to be the “home run” in vaccinology? (2 pts)

Q2. What is a T cell-dependent (TD) and T cell-independent (TI) antigen? Why are vaccinologists concerned with TI and TD antigens? How can one overcome any shortcoming in this type of antigen? (3 pts)

Q3. If you were tasked with creating a first generation vaccine against an extracellular pathogen, which vaccine development technology would you utilize and why? (2 pts)

Q4. Who should be considered the “Father of Vaccinology”…, Edward Jenner or Benjamin Jesty? Why? (2 pts)

Q5. Describe how an adjuvant, added to a subunit vaccine, might be used to direct the phenotype of an antigen-specific immune response. (2 pts)

Q6. Describe the three major components of a DNA vaccine. Describe one method for “facilitating” the delivery of a DNA vaccine. (2 pts)

Q7. List three reasons society vaccinates. (3 pts)

Q8. Describe the major difference(s) between active and passive vaccines. (2 pts)

Q9. Briefly describe three ways in which antibodies, induced after vaccination, can provide protection from disease. (3 pts)

Q10. Outline the public experiment in which Pasteur immunized with an anthrax vaccine. Why was the experiment so critical to the field of vaccinology? (2 pts)

Q11. Provide an example where a passive vaccine may be more effective than an active vaccine. (3 pts)

Q12. One classical method used to develop a live vaccine is attenuation in cell culture. Provide a description of the process and one vaccine that have been created using this methodology (3 pts).

Q13. Describe the process of using reassorted genomes as a method to attenuate live viral vaccines. List one vaccine that has been developed using this strategy (3 pts)

Q14. Describe methods to develop a temperature sensitive viral mutant vaccine strain. List one vaccine that has been developed using this strategy (3 pts).

Q15. List three reasons limiting the use of classical methods to attenuate bacterial vaccine strains (3 pts).

Q16. List two methods used to inactivate whole cell vaccines (2 pts).

Q17. Describe the differences between “recombinant human” and “recombinant humanized” monoclonal antibodies (2 pts).

Q18. Outline one technology that may represent a monumental leap forward for vaccinology and how it may influence the future of vaccinology. (3 pts)

Q19. List the three main players in a clinical trial and their major role (6 pts)

Q20. Describe the four clinical phases of vaccine testing pre-licensure and include the major objectives of each phase (3 pts).

Q21. What are the four focuses of the FDA while regulating the development of vaccines (2 pts).

Q22. Define a BLA and the two parts that are associated with the application (3 pts):

 

 

Describe the four clinical phases of vaccine testing pre-licensure and include the major objectives of each phase .
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