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PRINCIPLES OF

IMMUNIZATION
BLOK 26

LEARNING OBJECTIVES
At the end of this lecture the student should be able to describe:
Active and Passive Immunizations
Types of Vaccines (eg.whole-cell vaccines and subunit
vaccines).
Use of Adjuvants in Immunization.
Problems in Immunization
Understand the term Cold-chain monitoring and storage
conditions for the different types of vaccines.
Mode of Administration
Contraindications in Immunizations (side-effects).

The Extended Program of Immunization (EPI) in Indonesia.


Targeted-Immunizable Diseases in Indonesia
Immunization schedule

INTRODUCTION
Immunity and Immunization
Immunity to contagious disease protect
individu from infection.
Types of Immunity:
Innate immunity
Acquired immunity or adaptive immunity

INTRODUCTION
Innate immunity
Is present before any exposure to pathogens and is effective
from the time of birth
Involves non specific responses to pathogen

Acquired immunity or adaptive immunity


Develops only after exposure to inducing agents such as
microbes, toxins, or other foreign substances
Involves a very specific response to pathogen

INTRODUCTION
Active and passive immunization
Active immunity
Develops naturally in response to an infection
Can also develop following immunization, also called
vaccination
organism exposure, vaccine
In immunization
A non pathogenic form of a microbe or part of a microbe elicits an
immune response to an immunological memory for that microbe

INTRODUCTION
Passive immunity, which provide immediate, short time
protection
Is conferred naturally when IgG crosses the placenta from
mother to fetus or when IgA passes from mother to infant in
breast milk
Can be conferred artificially by injecting antibodies into a non
immune person

INTRODUCTION
Immunization
remarkably successful
very cost-effective

Infectious disease

EVOLUTION OF IMMUNIZATION
PROGRAMME

DEFINING AIMS / GOALS


Prevention of disease in individuals or groups
(immediate goal)

Reducing prevalence of disease (changed


disease epidemiology)

Eradication of disease (ultimate goal)

DEFINING AIMS / GOALS


Potential goals for reducing vaccinepreventable disease burden: eradication,
elimination, or control
Eradication:
reduction of the worldwide incidence of infection
by a specific agent to zero as a result of
deliberate efforts;
intervention measures are no longer needed

DEFINING AIMS / GOALS


Elimination:
reduction to zero, or to the level at which it is no
longer a public health problem, of the
incidence of a specified disease, or of infec-tion
caused by a specific agent, in a defined
geographic area;
continued intervention measures are required
to prevent reintroduction.

Control:
reduction of disease incidence, prevalence,
morbidity, or mortality.
Continue intervention maintaining reduction

DEFINING AIMS / GOALS


Herd immunity:
indirect protection observed in the unimmunised segment
of a population in which a large proportion is immunised

DEFINITION AND GENERAL CONCEPT


Vaccination:
administration of any vaccine or toxoid
(inactivated toxin) for prevention of disease.

Immunization:
process of inducing immunity artificially by either
vaccination (active immunization) or
administration of antibody (passive immunization).
Consist of:
Active immunization
Passive immunization

DEFINITION AND GENERAL CONCEPT


Active immunization:
administration of all or part of a microorganism or a modified
product of that microorganism (eg, a toxoid, a purified antigen,
or an antigen produced by genetic engineering) to evoke an
immunologic response that mimics that of natural infection but
that usually presents little or no risk to the recipient.
stimulating the immune system to produce antibodies and
cellular immune responses that protect against the infectious
agent.

DEFINITION AND GENERAL CONCEPT


Passive immunization:
provides temporary protection through administration of
exogenously produced antibody, such as immune globulin.
also occurs naturally through transplacental transmission of
antibodies to a fetus, which provides protection against many
infectious diseases for the first several months of the infant's life.

DEFINITION AND GENERAL CONCEPT


Immunizing agents protection against
disease:
Nearly complete lifelong protection
Partial protection

Immunizing agents include vaccines,


toxoids, antitoxins, and immune globulins
derived from human or animal donors
(Table 1.)

DEFINITION AND GENERAL CONCEPT


Table 1. Immunizing Agents
Agent

Definition

Vaccine

A preparation of proteins, polysaccharides, or nucleic acids of


pathogens that are delivered to the immune system as single entities, as
part of complex particles, or by live-attenuated agents or vectors, to
induce specific responses that inactivate, destroy, or suppress the
pathogen

Toxoid

A modified bacterial toxin that has been made nontoxic but retains the
capacity to stimulate the formation of antitoxin

Immune
globulin

An antibody-containing solution derived from human blood obtained by


cold ethanol fractionation of large pools of plasma and used primarily for
the maintenance of immunity of immunodeficient persons or for passive
immunization; available in intramuscular and intravenous preparations

Antitoxin An antibody derived from the serum of humans or animals after


stimulation with specific antigens; used to provide passive immunity

DEFINITION AND GENERAL CONCEPT


Most immunizing agents contain preservatives,
stabilizers, antibiotics, adjuvants, and a suspending
fluid (Table 2).
Component

Use and Examples

Preservatives,
stabilizers,
antibiotics

Constituents can inhibit or prevent bacterial growth or stabilize the


antigen. Materials such as mercurials or antibiotics are used. Allergic
reactions to any of the additives may occur.

Adjuvants

An aluminum salt is used in some vaccines to enhance the immune


response (e.g., toxoids, hepatitis B).

Suspending fluid

Sterile water, saline, or more complex fluids derived from the growing
media or biologic system in which the agent is produced (e.g., egg
antigens, cell culture ingredients, serum proteins).

IMMUNE RESPONSE TO
VACCINATION
How do vaccines work?
Immunological memory is the basis of vaccine protection

IMMUNE RESPONSE TO
VACCINATION

IMMUNE RESPONSE TO
VACCINATION

IMMUNE RESPONSE TO
VACCINATION

IMMUNE RESPONSE TO
VACCINATION

IMMUNE RESPONSE TO
VACCINATION

IMMUNE RESPONSE TO
VACCINATION

IMMUNE RESPONSE TO
VACCINATION
The immune system remembers

TYPES OF VACCINE
Vaccine
Live-attenuated or killed microorganisms
Inactivated or detoxified agents or their purified
components
DNA vaccine

TYPES OF VACCINE
Live attenuated vaccine
immunologic response ~ natural infection.
humoral and cell-mediated responses
long-lasting immunity, possibly lifelong
However, the strength of response, particularly the humoral
response, usually is less than that in natural infection, and
detectable antibodies can wane with time, resulting in some
loss of protection.

Induction immunity can be inhibited by passive antibody

TYPES OF VACCINE
Inactivated or purified Ag vaccines
response only to components in vaccine.
The nature of response depends on Ag type.
Protein (and glycoprotein) Ag both humoral immunity and
memory (T-helper lymphocytes)
Polysaccharide Ag only humoral antibody without Tlymphocyte stimulation and fail to induce anamnestic response
with repeated antigenic challenge. conjugation of
polysaccharides to protein carriers

TYPES OF VACCINE
Generally, multiple doses, usually three or more, are
necessary to induce satisfactory antibody levels that persist
for long periods; booster doses at longer intervals (10 or
more years) are sometimes needed to ensure lasting
protection.

TYPES OF VACCINE
Inactivated vaccine:
Types:
Whole organism
Purified protein or polysaccharide Ag from whole
organism
Purified antigen produced from genetically altered
organism
Chemically modified antigen

TYPES OF VACCINE

TYPES OF VACCINE
Bacterial Vaccine
Heat-sensitive
vaccines

lBCG

lOPV
lMeasles
lMMR
lVaricella
lYellow fever

Freezesensitive
vaccines

Freezesensitive
vaccines

Viral Vaccine

lDiphtheria
lTetanus
lPertusis
lCholera

lMeningococ
lPneumococ
lHib
lTyphoid Vi

lInfluenza
lIPV
lRabies
lHepatitis B
lHepatitis A

CHILDHOOD IMMUNIZATION
BCGVaccine

- live attenuated bacterial vaccine


- at birth or anytime after birth
- booster dose given at school entry

Contraindications: immunodeficiency, progressive dermatoses


Reaction: abscess at the site; axillary lymphadenopathy

BCG VACCINE
Usual reactions

induration: 2 4 wks

pustule formation: 5 7 wks

scar formation: 2 3 months

Accelerated Reactions:
induration: 2-3 days
pustule formation: 5-7 days
scar formation: 2-3 weeks

HEPATITIS B VACCINE
- inactivated viral antigen
- 0, 1 & 6 months
- children and adolescents who have not been vaccinated with Hep
B may begin series during any visit
Contraindication: anaphylactic reaction to previous dose
Reactions: pain and swelling at site, fever

HEPATITIS B VACCINE

HEPATITIS B VACCINE

HEPATITIS B VACCINE

HEPATITIS B VACCINE

DIPHTHERIA, TETANUS & PERTUSSIS

Usual Side Effects:

fever up to 72 hours (low to moderate grade)


restlessness and irritability
local reaction: pain and swelling at the site of injection

Contraindications:

encephalopathy within 7 days of administration of previous


dose
anaphylactic shock after a previous dose
progressive neurologic disorders

POLIOMYELITIS VACCINE
1. Oral Polio Vaccine (OPV)

- live attenuated (Sabin)


Absolute contraindications:
1. altered immune states, high dose steroids, radiation,
HIV/AIDS
2. pregnancy
3. household contacts of immunocompromised patients
Relative contraindications: vomiting and diarrhea
Adverse Reaction: paralysis
2.

Inactivated or Killed Polio Vaccine (IPV)

- recommended to decrease the incidence of vaccine-associated


paralytic polio (VAPP)

MEASLES VACCINE
- live attenuated
- given at 9 months but may be given as early as 6 months during
epidemics
Adverse reactions:

1. fever with or without rashes (5-12 days after


administration)
2. hypersensitivity reaction
Contraindication: immunocompromised state, pregnancy
Relative Contraindication: untreated active tuberculosis

MEASLES, MUMPS, RUBELLA (MMR) VACCINE


- live attenuated
- given at 12-15 months; a booster dose is recommended at 4-6
years old
Reactions:

1. fever with or without rashes (5-12 days after


administration - measles)
2. fever, swelling of parotid gland (mumps)
3. fever, mild rash, transient arthritis or arthralgia, postauricular lymphadenopathy (rubella)

MEASLES, MUMPS, RUBELLA (MMR) VACCINE

Reasons for giving 2 doses of MMR:

1. only 87-90% of children actually receive the measles


vaccine
2. 5% of children who receive the first vaccine wont
develop immunity
3. children who had an immune response to the first dose
could get a booster effect
Contraindications: same as other live vaccines

VARICELLA VACCINE
- live attenuated
- routinely given at age 12 months and up but can be given as early
as 9 months
- can be given within 5 days of exposure
- varicella vaccine prevents moderate to severe cases of chickenpox
Reactions:
-may develop few varicella-like lesions about 1 month after
vaccination

HEMOPHILUS INFLUENZAE B (HIB) VACCINE


- polysaccharide protein conjugate
Reactions:

low grade fever (2%)


pain and swelling (10-15%)

PNEUMOCOCCAL VACCINE

- PPV is given for children 2 yrs and above


Indications:

1.
2.
3.
4.
5.

patients undergoing splenectomy


sickle cell disease
asplenia
HIV
Routinely for children 2 months and above

HEPATITIS A VACCINE
- inactivated viral antigen
Indications:

1. persons traveling to areas with high prevalence of Hepatitis


A
2. occupational hazards
3. hemophiliacs contacts of infected persons
Reactions: pain and local swelling

INFLUENZA VACCINE

- inactivated vaccine
- should be administered before the start of flu season (February to
June)
Indications:

1. prophylaxis in children older than 6 months and adults


2. over 60 years
3. suffer from disease of cardiovascular system, metabolic
disease, cystic fibrosis, chronic respiratory disease, chronic
renal insufficiency

VACCINE RECOMENDATIONS

VACCINE RECOMMENDATIONS
Development of recommendations and
schedule for vaccine administration:
epidemiology of the disease,
age-specific morbidity and mortality,
vaccine immunogenicity,
risks of vaccine-related adverse reactions,
cost effectiveness,
ages of recommended routine health care visits.

VACCINE RECOMMENDATIONS
Priority:
delivering the primary childhood immunization series and
protecting adult women and their newborns against
tetanus.

VACCINE RECOMMENDATIONS
Each country has each own policies
Immunization schedule in Indonesia recommended by
IDAI (non PPI) and government (EPI/PPI)
PPI (Program Pengembangan Imunisasi):
BCG, Polio, Hepatitis B, DPT, Campak, Hib

IDAI (Ikatan Dokter Anak Indonesia):


PPI (diwajibkan)
Non PPI (dianjurkan)

VACCINE RECOMMENDATIONS
Expanded Program of Immunization (EPI) or
Pengembangan Program Imunisasi (PPI)
Goverements program in immunization to
achieve international commitment: Universal child
immunization (UCI):

Polio eradication = ERAPO


Maternal and neonatal tetanus elimination
Measles reduction
Improve immunization service quality
Establish safe injection practices standard
Safe waste disposal management

VACCINE RECOMENDATIONS

VACCINE RECOMMENDATIONS

VACCINE RECOMMENDATIONS

VACCINE RECOMMENDATIONS

JADWAL IMUNISASI

VACCINATION PROCEDURE

VACCINATION PROCEDURE
Vaccine storage and transportation
Prepare the equipment and supplies: for
vaccination and emergency proceduse
Prepare the administering:
Anamnesis, age, AEFI history, contra indication,
previous immunization interval and specific
precaution
Informed consent: benefit, AEFI risk
Physical examination

VACCINATION PROCEDURE
Administering vaccine:
Dose, interval
Location, angle and depths of injection (route,
site and needle length)

AEFI monitoring
Pack opened vaccines and disposing of
used equipment (used syringes and needles,
vials and rubbish)
Documentation

STORAGE AND DISTRIBUTION


Vaccine = biological product

Fragile/ easily damage

Decrease vaccine effectivity

STORAGE AND DISTRIBUTION


Cold chain
Vaccines sensitive to heat & freezing kept at
correct temperature from the time they are
manufactured until used.
The system used for keeping and distributing
vaccines in good condition = cold chain.
The cold chain consists of a series of storage and
transport links, all designed to keep vaccines
within an acceptable range until it reaches the
user.

STORAGE AND DISTRIBUTION

STORAGE AND DISTRIBUTION


Maintenance of the cold chain requires vaccines
and diluents to be:

collected from the manufacturer or an airport as soon as


they are available;
transported between 2C and 8C from the airport and from
one store to another;
stored at the correct temperature (see Figure 3A) in
primary/central and intermediate vaccine stores and in
health facilities;
transported between 2C and 8C to outreach sites and
during mobile sessions;
kept between 2C and 8C range during immunization
sessions; and
kept between 2C and 8C during return to health facilities
from outreach sites.

STORAGE AND DISTRIBUTION

Factors decrease vaccine effectivity :


* Type of vaccine
* Exposed to Inappropriate temperature
* Storage time/expired date
* Directly exposed to sunlight

STORAGE AND DISTRIBUTION

STORAGE AND DISTRIBUTION

STORAGE AND DISTRIBUTION


The shake test:
Can help give an idea whether
adsorbed vaccines (DTP, DT,
Td, TT or hepatitis B) have
been subjected to freezing
temperatures likely to have
damaged them.
After freezing, the vaccine no
longer has the appearance of
an homogenous cloudy liquid,
but tends to form flakes which
settle at the bottom of the vial
after shaking.

VACCINE VIAL MONITOR (VVM)


VACCINE VIAL MONITOR (VVM)



Heat marker /
Vaccine Vial
Monitor

HEPATITIS B VACCINE

VACCINE VIAL MONITOR (VVM)


USE the vaccine

VACCINE VIAL MONITOR (VVM)



Heat marker /
Vaccine Vial
Monitor

DPT-HB VACCINE

VACCINE VIAL MONITOR (VVM)


MEASLES VACCINE

CONTRAINDICATIONS TO
IMMUNIZATION
Anaphylaxis or a severe hypersensitivity reaction
absolute contraindication to subsequent doses of a
vaccine. Persons with a known allergy to a vaccine
component should not be vaccinated.
Do not give BCG or yellow fever vaccine to an
infant who exhibits the signs and symptoms of AIDS.
Other vaccines should be given.
If a parent strongly objects to an immunization for a
sick infant, do not give it. Ask the mother to come
back when the infant is well.

CONTRAINDICATIONS TO
IMMUNIZATION

CONTRAINDICATIONS TO
IMMUNIZATION

ADMINISTERING VACCINE

ADMINISTERING VACCINE

ADMINISTERING VACCINE

AEFI
Adverse event following immunization = KIPI
Definition
Is a medical incident that takes place after an
immunization, causes concern and is believed to be
caused by the immunization

AEFI
Classification
Vaccine reaction: event caused or precipitated by
the vaccine when given correctly; caused by inherent
properties of the vaccine.
Programme error: event caused by an error in vaccine
preparation, handling, or administration.
Coincidental event: event that happens after
immunization but is not caused by the vaccine - a
chance association.
Injection reaction: event from anxiety about, or pain
from, the injection itself rather than the vaccine.
Unknown: whose cause cannot be determined.

AEFI
Estimated AEFI rates following some childhood
vaccines
Vaccine

Estimated rate*

BCG

1 in 1 000 - 1 in 50 000 doses

OPV (oral polio


vaccine)

1 in 2-3 million doses (or 1 in 750 000


doses for the first dose)

Measles

1 in 1 million doses

DTP

1 in 750 000
* Only the rate for severe reactions has been quoted.

AEFI
Errors which can lead to AEFIs
Too much vaccine given in one dose.
Improper immunization site or route.
Syringes and needles improperly sterilized.
Vaccine reconstituted with incorrect diluent.
Wrong amount of diluent used.
Drug inadvertently substituted for vaccine or
diluent (can result from inattention when reading
labels on vials resulting in mistaken content).

AEFI
Vaccine prepared incorrectly for use e.g. an adsorbed
vaccine not being shaken properly before use.
Vaccine or diluent contaminated.
Vaccine stored incorrectly.
Contraindications ignored e.g. a child who
experienced a severe reaction after a previous dose
of a vaccine is immunized with the same vaccine.
Reconstituted vaccine used beyond six hours after
reconstitution or not thrown out at the end of an
immunization session and used at a subsequent one.

AEFI

AEFI

AEFI

SISA VAKSIN
BCG
setelah dilarutkan harus segera diberikan dalam 3
jam(simpan dalam suhu 2 8 C)

Polio
Setelah dibuka harus segera diberikan dalam 7 hari(simpan
dlm suhu 2 8 C)

SISA VAKSIN
DPT
Bila ada penggumpalan atau partikelyang tidak hilang
setelah dikocok !jangan dipakai

Campak
Setelah dilarutkan harus diberikan dlm 8 jam(simpan dlm
suhu 2 8 C)

PEMANTAUAN SETELAH VAKSINASI


Perhatikan keadaan umum
Tunggu 30 menit di ruang tunggu

SAFE INJECTION
Mengapa perlu?
Estimasi WHO : 30 % suntikan imunisasi tidak aman (WHO
bull. Oktober, 1999)
Imunisasi rutin(Soewarta,1999: 4 propinsi): tidak disterilkan :
spuit 38%, jarum 23 %alat suntik pakai ulang :krn tidak ada
jarum (18%), tidak ada spuit (4%)

Aman bagi
Yang disuntik
Penyuntik
lingkungan

SAFE INJECTION

Suntikan dapat menularkan : hepatitis B, Hepatitis C,


HIV, jamur, parasit, bakteri, menyebabkan abses
Penyebaran melalui suntikan lebih cepat daripada
melalui udara, mulut atau seks

SAFE INJECTION
TIDAK AMAN BAGI YANG DISUNTIK
*Vaksin
* Suhu > 8C, atau VVM telah terpapar panas
* Botol vaksin bocor, retak, atau terpasang jarum
* Ada partikel dalam larutan
* Telah dilarutkan lebih dari 6 jam
* Beku : DPT, DT, TT, HepB, Hib (tidak boleh beku)
* Uji kocok tetap menggumpal (kecuali HepB atau Hib)

SAFE INJECTION
* Alat suntik
Spuit disposable dipakai ulang
Hanya mengganti jarum
Tidak dibersihkan dulu langsung disterilkan
Hanya dengan desinfektan
Membakar jarum di api
Merebus dalam panci terbuka
Menyentuh ujung jarum

SAFE INJECTION
* Cara melarutkan / pengambilan vaksin
* Cairan pelarut untuk vaksin lain atau > 8C
* 1 spuit diisi beberapa dosis sekaligus
* jarum ditinggalkan menancap di vial
* Mencampur isi 2 vial

* Lokasi, posisi , kedalaman penyuntikan


* Tidak ada alat / obat gawat -kedaruratan

SAFE INJECTION
* Menekan luka berdarah dengan jari (semua
cairan tubuh dapat menularkan kuman)
* Membawa atau meletakkan alat suntik bekas
sembarangan (tidak langsung membuang ke
kotak limbah)
* Menyentuh atau mencabut jarum suntik

SAFE INJECTION
* Menutup kembali (recapping) jarum suntik
* Mengasah jarum bekas
* Memilah-milah tumpukan jarum bekas
* Tidak ada alat / obat gawat darurat

Tidak aman bagi lingkungan: Meninggalkan alat


suntik bekas sembarangan

TEMPAT PEMBUANGAN LIMBAH

PEMUSNAHAN KOTAK DAN ISI LIMBAH


* Dibakar dalam insinerator khusus (suhu 600 -1100C)
* risiko pencemaran kecil
* Rp. 10 30 juta, BBM / kayu bakar

* Dibakar dalam lubang atau drum


* Digiling
* Milling atau shreeding
* Serbuk masih infeksius
* 375-750 alat suntik / jam
* listrik 750 w

PENCATATAN
Nama dagang dan produsen
No. lot / seri vaksin
Tgl penyuntikan
Bagian tubuh yang disuntik (deltoid kiri, paha kanan
mis)

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