THIS PRESENTATION CONTAINS BRIEF DESCRIPTION OF VACCINES AND THEIR TYPES WITH THE RECENT ADVANCES IN VACCINES INCLUDING MUCOSAL AND TRANSDERMAL DELIVERY OF VACCINES.

1. VACCINE DRUG
DELIVERY SYSTEM
Prepared By:
Satyam V. Shukla
M. Pharm.
Semester I
Department Of Pharmaceutics
Guided By:
Dr. Chetan Borkhatariya
M. Pharm. PhD
(Assistant Professor)
Department Of Pharmaceutics
B. K. Mody Government Pharmacy College, Rajkot

2. CONTENTS
o INTRODUCTION
o VACCINE
o EVOLUTION & TYPES OF VACCINES
o UPTAKE OF ANTIGEN
o SINGLE SHOT VACCINE
o MUCOSAL DELIVERY OF VACCINE
o TRANSDERMAL DELIVERY OF
VACCINE
o RECENT ADVANCES OF VACCINES
2

3. INTRODUCTION
IMMUNOLOGY:
It can be referred as a branch of science which deals with the study of Immunity.
IMMUNE SYSTEM:
Immunity is a capacity of body to resist the Infection. And immune system is a
network of cells, tissues, and organs working in conjunction to defend the body
against the foreign invaders primarily microbes, bacteria, viruses, parasites, fungi, etc.

4. o INFECTION:
When a microorganism gets through the body’s natural
defenses and enters the bloodstream, it can cause illness and
this phenomenon is called as infection.
o ANTIGEN:
An antigen is a substance that enters the body and can cause
illness. When antigens are enters in the body, they may
trigger the immune system to respond.
o ANTIBODY:
An antibody, also known as an immunoglobulin, is a large,
y-shaped protein used by the immune system to identify and
neutralize foreign objects such as pathogenic bacteria and
viruses. The antibody recognizes a unique molecule of the
pathogen which is called an antigen.
4

5. 5 Immunoglobulin

6. VACCINE:
A vaccine is a biological preparation that
improves immunity to a particular disease.
Vaccines can be prophylactic or therapeutic
.The vaccine exposes humans to very small and
safe amounts of attenuated or killed viruses and
bacteria. When you are exposed to it in later life,
the immune system will learn to recognize and
attack infections
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7. MECHANISM OF VACCINE:
INJECTION
ANTIGEN INTRODUCTION
IMMUNE RESPONSE
ANTIBODY PRODUCTION
MEMORY FORMATION
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8. EVOLUTION OF VACCINE:
o Amongst various success stories of vaccines, one of
the first vaccine, against smallpox, a disease that had
killed millions of people over the centuries recognized
by British physician Edward Jenner in 1796. In the 19th
and 20th
centuries, scientists following Jenner’s model
developed new vaccines to fight numerous deadly
diseases, including polio, whooping cough, measles,
tetanus, etc.
o Louis Pasteur was a French biologist, microbiologist
and chemist renowned for his discoveries of the
principles of vaccination, microbial fermentation and
pasteurization. He created the first vaccines for rabies
and anthrax.
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9. TYPES OF VACCINES:
o There are several types of vaccines. Each type
is designed to boost our immune system and
prevent serious, life-threatening diseases.
Mainly they are divided into two categories:
1 . Traditional Vaccines
2 . Innovative Vaccines
9

10. 1. TRADITIONAL VACCINES:
Traditional vaccines use weakened or inactivated
forms of pathogens to stimulate the immune system
without causing the disease. They are:
Live Attenuated Vaccine:
Live attenuated vaccines contain a strain of the
living virus that has been weakened so that it does
not cause serious disease in people with healthy
immune systems
e.g. MRV Vaccine.
1 0

11. Inactivated vaccine (killed):
They are containing pathogens which are killed or
inactivated by usually a thermal or chemical process.
These vaccines trigger a strong immune reaction
similar to the body’s response to an actual infection,
helping build protection against future illness.
e.g. Typhoid Vaccine
Toxoid Vaccine:
Some harmful bacteria make toxins, which are
poisonous proteins that can cause disease in the body.
Some vaccines are made by taking these toxins and
making them harmless through a chemical process.
These harmless toxins are called “toxoids.”
1 1

12. Acellular or Subunit Vaccine:
“Acellular” means lacking whole cells, so acellular
vaccines don’t include complete bacteria or viruses.
These polysaccharides or proteins are recognized
by our immune system as “foreign,” triggering an
immune response against them.
e.g. Pertussis Vaccine
1 2

13. 2. INNOVATIVE VACCINES:
They includes several advanced types using
biotechnology to improve safety. They are:
Conjugate Vaccine:
Earlier polysaccharide vaccines used bacterial
surface sugars but were less effective in young
children. Linking these sugars to a carrier protein
improved immune response, making the vaccines
more effective for infants.
e.g. Pneumococcal Conjugate Vaccine
1 3

14. Recombinant Vaccine:
In this type of approach, a small DNA fragment from
the disease-causing bacteria or virus is inserted into a
plasmid, allowing the production of large amounts of
specific proteins that are used as vaccines.
e.g. Human papillomavirus (HPV) vaccine
DNA/RNA Vaccine :
It is a new innovative approach of vaccines where
either DNA or RNA of pathogen is inserted to human
cells which produces proteins encoded by the
inserted pathogenic genes. Hence the body detects
those proteins as foreign and produces strong
immune response against it.
e.g. HIV Vaccine
1 4

15. STEPS OF EXOGENOUS ANTIGEN UPTAKE
UPTAKE : Entry of native pathogens into the cell’s
degradation pathways
DEGRADATION: Partial breakdown of antigens
into peptides
ANTIGEN- MHC COMPLEX : Binding of
peptides to MHC molecules
ANTIGEN PRESENTATION: Transport and
expression of peptide-MHC complexes on the
surfaces of cells for reorganization by T-Cells

16. STEPS OF ENDOGENOUS ANTIGEN UPTAKE
UPTAKE : Antigens/pathogens already present in
the cells rephrase
DEGRADATION: Antigens synthesized in
cytoplasm undergo limited proteolytic degradation
in the cytoplasm
ANTIGEN- MHC COMPLEX : Loading of
peptides on MHC Class 1 molecules
ANTIGEN PRESENTATION: Transport and
Expression of peptide-MHC complexes on the
surfaces of cells for reorganization by T-Cells

17. SINGLE SHOT VACCINE:
The single-shot vaccine is a combination product of a
prime component antigen with an appropriate adjuvant and
a microsphere component that encapsulates antigen and
provides the booster immunizations by delayed release of
the antigen.
Single-shot vaccines, or single-dose vaccines, are
developed to deliver full immunity with just one dose,
simplifying vaccine administration and increasing
conveniency.
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18. COMPONENTS OF SINGLE SHOT
VACCINE:
ANTIGEN: Weakened or inactivated pathogen, a protein
subunit, or a piece of genetic material that codes for a
specific protein of the pathogen.
Biodegradable polymers: They can be ;
1 Natural polymers: Chitosan, Dextran (dex-HEMA),
Albumin, Collagen, Gelatin, etc.
2. Synthetic polymers: Aliphatic poly esters, PLGA
(Poly(lactic-co-glycolic acid)).
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19. Adjuvants: They are substances which are added in
vaccines to increase the therapeutics efficiency. Such as:
1. Aluminium Salts: Aluminium hydroxide, Phosphate
etc.
2. AS03: It is an oil-in-water adjuvant emulsion composed
of the surfactant polysorbate 80 and two biodegradable oils
(Polysorbate 80 & Squalene, DL-α-tocopherol)
3. MF59: It is a water-in-oil emulsion composed of
squalene, Span 85, and Tween 80 in 10 mM sodium citrate
buffer (6.5).
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20. FORMULATION OF SINGLE SHOT
VACCINE:
 An emulsion of dex-HEMA solution in an aqueous
solution of PEG solution is formed by mixing them in
a bioreactor vessel.
 The freeze-dried containing suspension is formed,
filled into vials and freed dried to make products
stable.
 When the freeze-dried product is rehydrated by an
aqueous solution, the hydrolysis (carbonate ester
groups) of dex-HEMA occurs.
 This will increase the mesh size in hydrogel network.
Hence the encapsulated protein will be released when
the mesh size exceeds the hydrodynamic diameter of
2 0
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21. 2 1
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Formulation and Manufacturing of Single shot Vaccine

22. COMMON SIDE EFFECTS ASSOCIATED WITH
SINGLE SHOT VACCINES:
 It can cause Muscle aches mainly at the site of action.
 Pain around injection site is also seen.
 Fever is the most common side effect of the Vaccine.
ADVANTAGES OF SINGLE SHOT VACCINE:
 Single shot vaccines are Economical comparatively.
 With one Injection 4 to 6 infections can be prevented
 Improved Patient compliance is possible due to no
need of reimmunization.
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23. DISADVANTAGES OF SINGLE SHOT VACCINE:
 Vaccines that utilize live organisms can become itself the
cause of illness.
 Sometimes the vaccine behaves like super antigen and
over stimulate the immune system.
SOME SINGLE SHOT VACCINES AVAILABLE
CURRENTLY ARE:
 Janssen COVID-19 Vaccine
 MMR Vaccine
 Yellow fever Vaccine
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24. MUCOSAL DELIVERY OF VACCINE:
 Mucosal vaccines are administered directly onto
mucosal surfaces, such as those in the sublingual,
digestive, respiratory, or urogenital tracts, to trigger an
immune response.
 This method allows the vaccine to target lymphoid
tissues under the mucous membranes.
 These tissues respond by recruiting immune cells and
promoting antibody secretion. Compared to
intramuscular or subcutaneous vaccines, mucosal
vaccines can thus more effectively engage the immune
system at the sites where many pathogens typically
enter the body. This can enhance protection against
infections localized to these areas.
2 4

25. DESIGNS FOR THE MUCOSAL VACCINES
DELIVERY:
On the basis of particulate carrier types, they can be;
 Microneedle
 Emulsions
 Liposomes
 Synthetic polymers
 Virus like particles
2 5

26. MICRONEEDLE:
 Microneedles are a vaccine delivery system consisting
of micron-sized projections that penetrate the
epidermis, enabling the mucosal administration of
vaccines with minimal discomfort.
 This method enhances patient compliance by providing
a painless vaccination experience.
 Microneedles have been widely utilized as vaccine
delivery systems.
2 6

27. 2 7
Oral Mucosa vs Microneedle Delivery

28.  Microneedles can be made from various materials and
designed in different shapes and sizes to reach specific
tissue depths. This flexibility allows for precise vaccine
delivery.
 They can be fabricated using various methods, leading
to a diverse range of sizes and shapes. This allows for
flexibility and precision in their design.
2 8

29. FORMULATION INCORPORATED IN MICRONEEDLE:
 Protein Antigens: These involve model proteins like
ovalbumin or specific proteins from pathogens. They work
by triggering an immune response in the body.
 Virus-like Particles (VLPs): VLPs imitate the structure of
actual viruses but aren't infectious. This makes them both
safe and effective for generating immunity.
 DNA Vaccines: These consist of small DNA fragments that
encode specific antigens. When taken up by cells, these
fragments lead to the production of the antigen, which then
stimulates an immune response.
2 9

30. ADVANTAGES OF MICRONEEDLE:
 They are minimally invasive and can cause little or no
pain.
 Self administration is possible.
 Targeted delivery to the mucosal tissues are possible
which induces robust immune response.
 They generally do not require cold chain storage.
 Extended immunity is possible when slow release of
antigen from microneedle takes place.
3 0

31. CHALLENGES FOR DEVELOPMENT OF MUCOSAL
VACCINES:
 One major difficulty is that delivering antigens to the
target cells or tissues is less consistent compared to
intramuscular or subcutaneous injections. This is because
the antigens must penetrate the mucosal barrier, which
serves as the body's natural defense mechanism.
 The Salivary flow can dilute and completely remove
vaccines before they can be taken up by antigen
presenting cells in the tissue. It also contains a range of
enzymes that may alter the vaccine prior to antigen
presenting cell uptake.
3 1

32. TRANSDERMAL DELIVERY OF
VACCINES:
 Transdermal Delivery of Vaccines is a method where
vaccines are administered through the skin using
specialized devices like patches
 This approach allows the vaccine to be absorbed into
the body through the skin, often providing a painless
and convenient alternative to traditional needle
injections.
 The Transdermal vaccines may cause similar or even
higher immune responses in comparison to
intramuscular injections.
3 2

33. TRANSDERMAL DELIVERY OF
VACCINES:
Numerous transdermal drug delivery techniques used for
vaccine delivery can be:
 Sonophoresis (Ultrasound)
 Iontophoresis
 Microneedles
 Electroporation
 Thermal ablation or microporation
3 3

34. RECENT ADVANCES IN VACCINES:
Recent advancements in vaccines include formulation of
various vaccines such as:
 mRNA Vaccines
 DNA Vaccines
 Edible vaccines
 Vector vaccines
3 4

35. mRNA VACCINES:
 mRNA vaccines have recently attracted significant
attention because they can speed up vaccine
development, improve safety and efficacy, and address
diseases that other approaches have struggled to prevent.
 mRNA is non-infectious and non-integrating and is
quickly broken down by normal cellular processes after
injection, reducing the risk of toxicity and long-term side
effects.
 mRNA vaccines have the distinct advantage of not
inducing vector-specific immunity, avoiding interference
from pre-existing or newly developed vector immunity in
subsequent vaccinations.
3 5

36. 3 6

37. mRNA VACCINES:
 mRNA vaccines can deliver multiple mRNAs to the
same cell, enabling the formation of multi-protein
complexes or protein antigens from various pathogens.
This capability allows the creation of a single vaccine
that can target multiple diseases.
E.g. :
 Pfizer-BioNTech COVID-19 Vaccine,
 Moderna COVID-19 Vaccine
3 7

38. DNA VACCINE:
 A DNA vaccine is a type of engineered genetic material that
carries instructions for producing a specific protein antigen.
 This genetic material is directly injected into to trigger an
immune response.
 After being taken in by host cells, it expresses an antigen
protein, thereby inducing non-specific and specific immune
responses, playing an important role in immune protection
effect.
 DNA vaccine represent a powerful approach to express
antigens in vivo for the generation of both humoral and
cellular immune response and the generation of needed
vaccines.
3 8

39. 3 9

40. ADVANTAGES OF DNA VACCINE:
 The risk of either reversion to a disease-causing form
or secondary infection is reduced as the DNA vaccine
plasmids are non-live, non-replicating and non-
spreading.
 They are considered to be safer than many other
vaccines.
 They are stable, easily stored and can be manufactured
on large scale.
4 0

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46. THANK YOU
BY SATHYA