Laboratorium Farmakologi-Toksikologi

(Devyani Diah Wulansari)

1.Pengertian imunisasi, vaksinasi, vaksin
2.Peran farmasis dalam imuniasi
3.Tujuan dan manfaat imunisasi
4.Mekanisme aksi vaksin secara imunologi
5.Imunitas yang terlibat dalam vaksinasi
6.Tipe/ kategori vaksin
7.Rute pemberian vaksin
8.Bentuk sediaan vaksin
9. Komposisi vaksin
10.Stabilitas vaksin
11.Indikasi dan kontraindikasi
12. Adverse effect
 Edward Jenner
SMALLPOX 1978

Introducing fluid
from a cowpox
pustule into
people
 The epidemiology of and
patient populations at risk for

Pharmacist’s Role in Immunization

vaccine-preventable diseases
Immunologic drug interactions
Public health goals for
immunization

Vaccine dosing

Vaccine safety

Proper dose preparation and

injection technique
Screening for
contraindications and
precautions of vaccination
Signs and symptoms of
adverse reactions to vaccines
Vaccine stability
Vaccines are also medicines

Potential for adverse effects

Multiple ingredients

Potential for interaction with disease and other medicines

Also need to comply with standards of safety, efficacy and quality

 The process of eliciting a long-lived
state of protective immunity against a
disease-causing pathogen
The process of stimulating protective adaptive immune
responses against microbes by exposure to
nonpathogenic forms or components of the microbes.
 Immuno
genic
Long
Single
lasting
dose immunity

The ideal
vaccine
Combined Safe

Afford
Stable
able
10/10/2011 Vaccinology. 9
COMBINATION VACCINE
↓ Cost of
stocking & ↓ Cost of extra ↑ timelineess of
administering health care visits vaccination
vaccine

Facilitating the Evaluate the

addition of new poency of
vaccine interaction
 Control

Vaccination Elimination

Community
Immunity

Make hosts resistant to infection without having to experience disease

MYCOBACTERIA CELL ENVELOPE

Other glycolipids

Mycolic acids Isoniazid

Arabinogalactan Ethambutol
Peptidoglikan Cycloserine
Plasma membrane
 BCG

Attenuated
strain of
M. bovis
Susceptible host
Infected host
86% coverage

Susceptible host
Infected host
Lack of susceptible host
Vaccine Efficacy (VE)

Vaccinated

IV = 2/10 = 0,2

Unvaccinated

IU = 9/10 = 0,9

0,9 – 0,2
VE = = 78%
0,9
 Based on 2 key elements of
adaptive immunity

Specificity

Memory
KITA LAHIR SUDAH DIBERIKAN IMUNITAS TETAPI MENGAPA
MASIH PERLU DIVAKSIN ??
VACCINATION  INNATE OR ADAPTIVE IMMUNITY ?
 Adaptive
immunity

Natural Artificial

Active Passive Active Passive

MENGAPA SUDAH ADA PASSIVE IMMUNITY, TETAPI MASIH MEMBUTUHKAN
ACTIVE IMMUNITY (VAKSIN) ??
 Human/horse
Botulism Horse antitoxin Rabies
polyclonal Ab
Cytomegalovir Human Respiratory Monoclonal
us polyclonal Ab disease antiRSV

Diphteria Horse antitoxin Snake bite Horse antivenin

Pooled human
Hepatitis A & B Tetanus Horse antitoxin
imunoglobulin

Pooled human Varicella Human

Measles
imunoglobulin zooster virus polyclonal Ab
 Histamin Respon Inflamasi

TNF-α Nekrosis

Kemokin Kemotaksis

Sitokin
Interaksi Demam
IL
komponen
antigenik dengan
reseptor di Wound
Faktor
permukaan Healing
membran sel pertumbuhan
dendritik
 Sel dendritik mempresentasikan zat
antigenik di permukaan membran

Sel T teraktivasi menjadi

sel T helper

SPESIFIK

Sel T mengenali antigenik yang

dipresentasikan oleh APC

Sel T helper berikatan

dengan antigenik Immature B cell mengikat
dipermukaan sel B  antigenik dipermukaan
Pelepasan sitokin

Antigenik dipresentasikan
dipermukaan sel B
 Sitokin menstimulasi sel B

Sel B plasma

Sel B mengalami priliferasi dan

Sel B memori diferensiasi menjadi sel B plasma
dan sel B memori
Sel B plasma

Sel B plasma memproduksi

antibodi

Antibodi di dalam sirkulasi

Tubercle
BCG vaccine MMR MMR vaccine
bacillus
Hepatitis B
Polio virus OPV, IPV Hepatitis B
vaccine

Diphteria DT vaccine Rotavirus

Rotavirus
vaccine
HiB conjugate
Tetanus TT vaccine HiB
vaccine

Pneumococcal
Pertusis wP, aP vaccine Pneumoniae
vaccine
Vaccines Vaccine Type Serum IgG Mucosal IgG Mucosal IgA T Cell TLR Ligands
Hepatitis B Inactivated exotoxin ++
BCG Live attenuated ++ CD4 TLR2 Peptidoglikan,
lipoprotein,
lipopolisakarida,
glikolipid
TLR3 Viral doubled-stranded
RNA
OPV Live attenuated ++ ++ ++
IPV Killed
HiB Conjugate ++ ++ TLR2 Peptidoglikan,
lipoprotein,
lipopolisakarida,
glikolipid
TLR3 Viral doubled-stranded
RNA
Diphteria toxoid Toxoid ++ ++
Measles Live attenuated ++ CD8
Mumps Live attenuated ++
Rubella Live attenuated ++
Vaccines Vaccine Type Serum IgG Mucosal IgG Mucosal IgA T Cell TLR Ligands
Pertusis Inactivated exotoxin ++ CD4
Tetanus toxoid Toxoid ++
Pneumococcal Inactivated ++ ++ TLR2 Peptidoglikan,
exotoxin/conjugate lipoprotein,
lipopolisakarida,
glikolipid
TLR3 Viral doubled-stranded
RNA
NOD1, CpG Olignucleotides
NOD2 Unknown
peptidoglycans
Varicella Live attenuated ++ CD4

Rotavirus Live attenuated ++

Influenza Inactivated/killed ++ ++ CD8 TLR7 Lipotechoic acid,
lipoprotein
Meningococcal Polisaccharide ++ ++
Papillomavirus Virus like particles ++ ++ TLR3 Viral doubled-stranded
(VLPs) RNA
 LIVE ATTENUATED VACCINE

BACTERIA VIRUS
Tuberculosis (BCG) OPV
Measles
Rotavirus

IMMUNE RESPONSE
 Memberikan stimulasi antigenik yang berkelanjutan  memicu produksi sel memori
 Memberikan respon kekebalan = ketika terjadi infeksi

SAFETY AND STABILITY

 Patogen yang dilemahkan dapat berubah menjadi virulen (sangat jarang)
 Potensi berbahaya bagi pasien immunocompromised
 Dikemas dalam bentuk serbuk kering  butuh pelarut yang sesuai
 Pada proses distribusi dan penyimpanan  perlu sistem rantai dingin yang ketat
 INACTIVATED VACCINE

BACTERIA VIRUS
wP (Pertusis) IPV

IMMUNE RESPONSE
 Tidak selalu memberikan respon imun saat dosis pertama
 Perlu beberapa dosis untuk memicu kekebalan jangka panjang

SAFETY AND STABILITY

 Tidak berisiko merangsang suatu penyakit
 Lebih stabil dibandingkan live attenuated vaccine
 SUB UNIT VACCINE

BACTERIA
aP (Pertusis)  protein : inactivated pertussis toxin
PROTEIN BASED
VIRUS
Hepatitis B  protein : Hepatitis B virus surface antigen (HBsAg)

BACTERIA
POLISACCHARIDES Pneumococcal
Meningococcal

BACTERIA
CONJUGATE HiB
Pneumococcal (PCV-7,10,13)
CONJUGATE VACCINE
 SUB UNIT VACCINE

IMMUNE RESPONSE
 Menentukan kombinasi antigen untuk menstimulasi respon imun efektif
 Antigen spesifik  adverse reaction ↓
 Respon imun lambat (PS)
 Peningkatan titer antibodi lambat (PS)
 Tidak ada memori kekebalan (PS)
 Dapat mengikat polisakarida dengan protein karier  stimulasi respon imun jangka panjang pada bayi
(Conjugate)

SAFETY AND STABILITY

 Tidak berisiko merangsang suatu penyakit
 Risiko denaturasi  menjadi tidak spesifik
 TOXOID VACCINE

BACTERIA
Diphteria toxoid
Tetanus toxoid

IMMUNE RESPONSE
 Antigen  inactivated exotoxin (toksin berbasis protein yang tidak berbahaya)
 Untuk meningkatkan kekebalan  + adjuvan (garam aluminium/kalsium)

SAFETY AND STABILITY

 Tidak dapat berubah menjadi virulen
 Stabil dan tahan lama
Oral IM
OPV Hepatitis

Rotavirus HiB

IPV

Pneumo- SC Measles
ID BCG
coccal

Yellow
fever
 Lebih mudah dan acceptable karena tidak
membutuhkan jarum suntik

Untuk vaksin yang mengandung adjuvan 

menurunkan efek lokal yang tidak diinginkan
Disuntikkan antara dermis dan otot

Untuk mengurangi resiko

neurovascular injury
 Antigens Stabilizers Adjuvants

• Weakened/killed • MgCl2 • Aluminium

• Subunit, etc • Lactose-sorbitol hydroxide
• Aliminium
phosphate
 Cell Culture
Antibiotics Preservatives
Materials
• Neomycine • Thimerosal • Egg proteins
• Formaldehyde
 Vaksin Anafilaksis / alergi Kehamilan Immunocompromised

BCG

DPT

OPV

IPV

Measles

Hepatitis

Rotavirus

HiB

Pneumococcal

Yellow fever
Vaccine Local Reactions Systemic Reactions
Irritability/systemic
Pain, Swelling, Redness Fever >380 C
symptomps
BCG 90-95% - -
Hepatitis B Adults up to 15% 1-6% -
Childrren up to 5%
HiB 5-15% 2-10%
MMR ~ 10% 5-15% 5% Rash
OPV None <1% <1%
DPT Up to 50% Up to 50% Up to 55%
Pneumococcal conjugate ~ 20% ~ 20% ~ 20%
Treatment Cold cloth at injection site Give extra oral fluid Give extra oral fluid
Paracetamol Wear cool clothing
Tepid sponge or bath
Paracetamol
Mengapa ada vaksin yang diberikan
tidak pada 0 bulan ?
Mengapa ada vaksin yang
diberikan berulang?