Clinical Vaccine Development

Question 1

Steps in the vaccine development pathway

Answer 1

• pre-clinical
• human trials
• licensure
• post-licensure evaluation

Question 2

Describe the phases in vaccine development

Answer 2

1 = first in man
2= proof of concept
3 = licensure trial
4 = post-licensure study

Question 3

Explain the concept of “step down”

Answer 3

Going from trial participants that are less vulnerable to more vulnerable

Question 4

Elements of a clinical trial

Answer 4

• study design and protocol
• implementation of protocol
• analysis and data management
• ethics and regulatory

Question 5

Possible study design issues

Answer 5

• right research question
• right study population
• correct trial procedures
• measuring the right outocomes

Question 6

Why is the RCT the best design for a vaccine trial?

Answer 6

• avoids confounders
• prevents bias
• proves causality
• answers the research question directly

Question 7

Vaccine trial endpoints

Answer 7

• safety
• efficacy
• immunogenicity

Question 8

Clinical endpoints

Answer 8

• injection site reactions
• systemic side-effects
• safety blood tests
• incidence of disease

Question 9

How are participants rights and safety ensured?

Answer 9

• guidelines and legislation
• ethics committees
• regulatory authorities
• the integrity of the investigator

Question 10

Guidelines for ethical research

Answer 10

• good clinical practice (GCP)

- declaration of Helsinki

Question 11

ICH

Answer 11

international conference on harmonisation

Question 12

What’s in GCP?

Answer 12

• how to conduct clinical trials
• roles and responsibilities
• informed consent and assent

Question 13

Principles of the Declaration of Helsinki

Answer 13

• respect for participant
• the right to informed consent (autonomy)
• risk vs benefit
• suitable training and qualification
• provision for oversight