540 - Drug Delivery Systems - Exam Iii - Vaccines

Front 1

What is the goal of Immunization?

Back 1

To protect against disease upon subsequent exposure to the infection

Front 2

Immunization Timing

Back 2

-Must immunize before exposure
-Childhood and adult immunization schedules updated frequently and published annually.

Front 3

What makes an ideal vaccine?

Back 3

-Induces protective immune response in all individuals
-No adverse events
-Cheap to produce
-Not temperature sensitive

Front 4

What is active immunity?

Back 4

-Stimulate the host to produce a protective response to a pathogen. (e.g. natural infection, immunization)
-Relies on immunologic memory

Front 5

What are the immune globulins?

Back 5

IgA: found in secretions
IgE: involved in allergy and anaphylaxis; immune response to parasites
IgG: found in large amounts in serum; major antibody of secondary response
IgM: predominant early antibody

Front 6

What are the characteristics of the secondary antibody response?

Back 6

-No maturation of IgM response
-Antibodies response after secondary exposure
-higher affinity
- appear more quickly
- persist longer
- attain higher concentration
- predominantly IgG)

Front 7

What are the three characteristics of live attenuated vaccines?

Back 7

1. Contain live organisms
2. Undergo limited replication in host
3. Produce immune response without causing disease

Front 8

What are examples of live attenuated vaccines?

Back 8

-measles
-mumps
-rubella
-varicella, zoster
-rotavirus
-influenza (nasal)
-oral polio
-typhoid
-yellow fever

Front 9

What are the issues with live vaccines?

Back 9

-Single dose to produce long-lasting immunity
-Repeat doses do not boost
-Timing
-Contraindicated in pregnancy, immunosuppressed

Front 10

What are whole, inactivated vaccines?

Back 10

-grown in culture
-exposed to heat, chemical to inactivate
-Sometimes purified to contain only portion needed to induce immunity

Front 11

What are examples of whole, inactivated vaccines?

Back 11

-hepatitis A
-Influenza
-polio
-rabies

Front 12

What are the three issues with inactivated vaccines?

Back 12

1. Multiple doses to produce positive immunity
2. Generally require booster doses
3. Minimal interference from circulating antibody.

Front 13

What are fractional vaccines?

Back 13

-Portion of pathogen that induces protective immunity
-Reduce adverse effects associated with vaccine administration
-injection site soreness, redness, systemic reactions

Front 14

What are examples of fractional vaccines/

Back 14

-Polysaccharide vaccines
-Recombinant DNA vaccines
-Toxoids
-other examples
-influenza
-acellular pertusis

Front 15

What are the five characteristics of polysaccharide vaccines?

Back 15

1. Composed of long chains of sugar molecules from bacterial capsule
2. Immune response T cell independent (stimulate B cells without T helper cells)
3. ineffective in children <2 years
4. No booster response
5. Predominant antibody response is IgM

Front 16

What are examples of polysaccharide vaccines?

Back 16

-Pneumococcal (PPSV23)
-Meningococcal (MPSV4)

Front 17

What are the characteristics of conjugate vaccines?

Back 17

1. polysaccharide linked to protein making it a more potent vaccine.
2. Conjugation overcomes the disadvantages of polysaccharide vaccines.

Front 18

What are the examples of conjugate vaccines?

Back 18

-Haemophilus influenzae type b
-Pneumococcal (PCV13)
-Meningococcal conjugate (MCV4)

Front 19

What is recombinant DNA technology?

Back 19

-Insert gene for antigen in microorganism
-Microorganism produces antigenic protein
-Antigenic protein harvested and purified for use a vaccine.

Front 20

What is the advantage of recombinant DNA vaccines?

Back 20

-large amount of pure antigen

Front 21

What is the disadvantage of recombinant DNA vaccines?

Back 21

-expensive

Front 22

What are the examples of recombinant DNA vaccines?

Back 22

-Hepatitis B
-Human papillomavirus

Front 23

What are toxoids?

Back 23

-Inactivated bacterial toxins
-Immune response to toxin produced by infecting bacteria

Front 24

What are examples of toxoids?

Back 24

-tetanus
-diphtheria

Front 25

What are nucleic acid vaccines?

Back 25

-Immune response to the protein encoded by plasmid DNA.
-Induces cell mediated and antibody response.

Front 26

What are the three nucleic acid vaccine characteristics?

Back 26

1. Easy to manufacture
2. Inexpensive
3. Numerous trials (prophylaxis, therapeutic)

Front 27

How does a nucleic acid vaccine work?

Back 27

-Gene for antigenic portion of a pathogen
-host cells...
-take up foreign DNA
-express the pathogen gene
-produce antigenic pathogen protein

Front 28

What is the immune response to nucleic acid vaccines?

Back 28

-Myocytes likely play secondary role
-Myocytes may be antigen producers
-Antigen presenting cells induce immune response
-Antigen presenting cells directly transfected
-Lysed myocytes supply additional DNA for macrophages

Front 29

Nucleic Acid Vaccines

Back 29

-Because pathogen protein originates inside cell, strong cell-mediated immunity elicited
-Long-lasting immunity

Front 30

What are the three advantages of nucleic acid vaccines?

Back 30

1. Cell mediated and antibody responses
2. Pure
3. No infectious risk

Front 31

What are examples of nucleic acid vaccines?

Back 31

-hepatitis C virus
-Herpes simplex virus
-Human Immunodeficiency virus
-Parasites
-Cancer

Front 32

What cautions should be taken with DNA vaccines?

Back 32

-safety profile
-human efficacy
-administration strategy
-stability

Front 33

What are adjuvants?

Back 33

-Substance that enhances the immune response to the antigen with which it is mixed
-Aluminum-containing materials only approved adjuvant in U.S.

Front 34

What is the mechanism of adjuvants?

Back 34

-not completely determined
-make antigen less soluble; stays at injection site longer
-enhance immune stimulatory signals
-cause inflammatory response

Front 35

Thimerosal in vaccines

Back 35

-effective preservative that contains ethyl mercury
-Thimerosal-free preparations now available in U.S

Front 36

Vaccine preparation

Back 36

-vaccine should be prepared at the time of administration
-pre-filling syringes is strongly discouraged

Front 37

what is intramuscular administration?

Back 37

-vaccine delivered into muscle
-Needle size
-adults 1 to 1.5 inches; 22-25 gauge
-children 5/8 to 1.25 inch; 22-25 gauge

Front 38

What is subcutaneous administration?

Back 38

-delivered to fatty tissue under skin
-tissue pinched for administration to avoid slipping into muscle
-Needle size
-5/8 inch; 23-25 gauge for all

Front 39

What are the characteristics of oral administration?

Back 39

-oral or muscosal pathogens
-live attenuated pathogens
-IgA production

Front 40

What are the characteristics of edible vaccines?

Back 40

-Transgenic plants
-Oral administration
-inexpensive to produce
-Rapid upscale of production
-Minimization of storage problems
-Plant produced antigens
-Plant cell walls may protect vaccine antigen from stomach acid

Front 41

What are the advantages of edible vaccines?

Back 41

1. Edible
2. Relatively stable
3. Production scale up
4. Mucosal immunity

Front 42

What is transdermal immunization?

Back 42

-Needle-free delivery
-Patch application

Front 43

What makes up the skin immune system?

Back 43

-Barrier stratum corneum (disrupt with hydration (occlusion))
-Langerhans cells
-close proximity to stratum corneum
- carry antigen to lymph nodes

Front 44

Intradermal Influenza Vaccine

Back 44

-injection site reactions common
-Well-accepted by healthy adults

Front 45

What is nasal or mucosal administration?

Back 45

-Antigen delivered to mucosal surface.
-IgA production
-nasal
-vaginal or rectal administration under investigation

Front 46

What are the three critical issues of vaccine handling and storage?

Back 46

1. exposure to temperatures outside recommended ranges can reduce potency
2. errors cost money
3. loss of patient confidence

Front 47

Storage Temperatures

Back 47

-Each vaccine has recommended storage temperature
-Most live vaccines can tolerate freezing
-Inactivated vaccine damaged by heat or freezing
-Temperature excursions: out of range temperatures

Front 48

Freezer Temperatures

Back 48

-Consider defrost cycles
-Recommended freezer temperatures
-between -58 and 5 F
-between -50 and -15 C

Front 49

-Refrigerator Temperatures

Back 49

Recommended
-Between 35 and 46 F
-Between 2 and 8 C

Front 50

Monitoring Temperature

Back 50

-Twice daily recording of temperatures
-Graphing thermometers

Front 51

Thermometers

Back 51

-Placed in each compartment
-Calibrated thermometer with periodic recalibration as recommended by the manufacturer

Front 52

What are two methods for continuous monitoring of temperature?

Back 52

-alarms when closed
-notification sent to email or cell phone

Front 53

How to handle temperature excursions?

Back 53

-Do not discard
-vaccine delivered that may have been exposed to heat or cold
-vaccine inadvertently left out
-equipment malfunction or power outage
-Separate from other inventory
-Call vaccine manufacturer for guidance
- call health department for guidance

Front 54

What to do for clinical immunization program plans?

Back 54

-Designate an individual and back-up to handle vaccines
-Written plan for ordering and deliveries
-Emergency back-up written plan
-natural disaster or other power outage
-back up generator
-alternate site

Front 55

What is the appropriate storage equipment?

Back 55

-Refrigerator/Freezer
-standard household combination with separate sealed doors is ok
-dorm-style refrigerator should not be used unless it is only temporary storage
-Stand alone refrigerators and freezers preferred
- use only to store biologics
-consider size

Front 56

Where should vaccines be placed in the storage unit?

Back 56

-NOT IN THE DOOR
-middle of unit on shelves
-spaced for adequate air circulation
-strategic storage to minimize error
-Store jugs of water or frozen gel packs to maintain temperature

Front 57

What is the global immunization issue?

Back 57

-Vaccine integrity in areas of the world with no or unreliable electricity supply.