toto

For rare diseases what type of control should be used

internally controlled study

What endpoint should be used if results are needed quickly

surrogate

What active safety monitoring system is used

VSD

What passive vaccine safety monitoring system is used

VAERS

What do efficacy endpoints measure

Monitors if there is improvement of mortality, symptom relief, or disease progression

What is measured in a surrogate endpoint

blood test or other test to determine if an immune response occurred (immune reaction may correlate with protection)

Why is surrogate endpoints shorter to collect than efficacy endpoints

lower scale of sample size and also focuses on shorter period of time

Why could not manufacturers use a surrogate endpoint fo COVID19 vaccines

not enough information was known about immune responses to covid

Why are cytokines difficult to use as therapeutics

act locally, act in combination with other cytokines, and have pleiotropic effects

What limits the efficacy of cytokines as therapeutics

dose-limiting toxicity, poor PK and off target effects

Why is IL-2 a target for anticancer drugs

IL-2 activates T cells which can be used to target tumor specific T cells to attack tumors

How can you reduce pleotropic effect of IL-2

make IL-2 more specific to which T cell it activates effector T cells or Treg

How can you improve PK of cytokines

protein fusion with albumin or antibodies OR pegylation

How can you improve targeted release of cytokines at local sites

nanoparticles that are stable in circulation but unstable at site of action or inactive prodrugs

Why is activation of innate immunity crucial for vaccine development

innate will prime adaptive immunity

What is the purpose of an adjuvant

activate innate immune system

What is herd immunity

increasing immunity of patients in a population to decrease transmission therefore protecting un-immune individuals

How does incubation time of a pathogen affect immune memory from a vaccine

longer incubation periods (between pathogen exposure and onset of symptoms) allow for memory B cells to generate antibodies above threshold needed for protection. Short incubation periods may not allow for enough time for memory b cells to respond and be sufficient to protect against disease

What populations generally do not respond well to vaccines for the general public

elderly and infants

What disease has highest vaccine effectiveness and vaccination rate

measles

Is herd immunity plausible for covid?

No! Because it has short incubation and has pre-symptomatic spread

What vaccines do not need adjuvants

live attenuated, mRNA, DNA, viral vectored, polysaccharide vaccines

What vaccine has AS01 adjuvant

shingrix and malaria

What types of antigens would generate CD4+ T cell responses

antigens found outside of cells

What types of antigens would generate CD8+ T cell responses

antigens found inside of cells

What vaccine is the quickest to produce

whole inactivated vaccine

What vaccine would be good against a pathogen that constantly mutates

whole inactivated vaccine

Even though measles mutates quickly why does the same vaccine still work

measles virus cannot change the single B cell epitome that is essential for viral entry

Which types of vaccines need an adjuvant

inactivated and protein subunits

When would you use a whole microbe antigen

when we don’t have enough information about immune system