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PENTINGNYA KELENGKAPAN DOSIS IMUNISASI DPT POLIO UNTUK PERLINDUNGAN JANGKA PANJANG

Asri purwanti

CV
Nama Lengkap : dr. Asri Purwanti SpA(K), MPd Tempat/Tanggal Lahir : Yogyakarta, 06-11-1955 Riwayat Pendidikan Dokter Umum (S1) : FK Universitas Diponegoro Semarang Tahun 1982 Dokter Umum Dokter Spesialis (S2) 1994 Magister Pendidikan dan Konseling UNNES Tahun 2002 Konsulen Kolegium Kesehatan Anak Indonesia / Pediatric Endocrinologi Konsultan (S2) Tahun 2007 Program S3 in stem cell research in Down syndrome Pendidikan Tambahan : 1995 : Pendidikan Lanjutan Klinik di Klinik Tumbuh Kembang Khusus dan Genetika Klinis (dismorfologi) RSAB Harapan Kita Tempat di Jakarta 1996 : Kursus Genetika Klinis NUH Singapore Tempat di Singapore 2005 : Orientasi di Sub Bidang Endokrinologi Anak FKUI Tempat di Jakarta 2005 : Felloship APPES Pediatric Endocrinologi Tempat di Wuhan, Cina

DPT POLIO MUNCUL LAGI..

BESARAN MASALAH PD3I DAN PERKIRAAN PENCAPAIAN CAKUPAN IMUNISASI DI INDONESIA TAHUN 2010 (WHOUNICEF)
No. of reported cases 2009 2008 2007 2006 2005

Msalah infeksi diphteri

BESARAN MASALAH PENYAKIT


DISTRIBUSI KLB DIPHTERI DI JATIM TH 2000 2012
Kab/Kota Kasus
665

40
35 30

692700
600 500 400

25
20 15 10 5 0
18 140 304

300

200
52 15 86 76

100

11 16

11

3
5

9 15

44 17

20

21

24

31

38

38

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

KASUS DIFTERI DI JAWA BARAT 2001

Gambar 2. Persentasi Subjek dengan Titer Protektif Optimal ( > 0,1 )


40

36.8
35

Titer Protektif Optimal > 0,1

30 25 20 15 10

30 24.3 19.3 16.8 20 17.5 15 12.8 7.8 7.8 5.1 0


<1 1_2 2_3 3_4 4_5 5_6 SD I SD II SD III SD IV SD V SD VI SM P 1 SM P 2 SM P 3

25

5 0

5.2

Umur dan Kelas Sekolah

DOSIS PENGUAT/ BOOSTER IMUNISASI DASAR


Survei imunitas difteri di Eropa:
Kadar antibodi rendah pada anak usia sekolah di negara yang tidak melaksanakan dosis penguat pada usia prasekolah Mis: Swedia: imunisasi pada usia 3,5,12 bulan dan 1 kali dosis penguat di usia 10 tahun

* Seroprotection: antitoxin concentrations 0.1 IU/ml **ESEN: European Sero-Epidemiology Network *** Children who received primed at 2,4,6 months showed even lower seroprotection rates and were removed

PELAKSANAAN DOSIS PENGUAT IMUNISASI DASAR DI EROPA


Use

of a full diphtheria toxoid dose for preschool booster is the standard in Europe

Countries using full diphtheria toxoid dose (D) Countries using reduced diphtheria dose (d)

EU.VACNET. National Childhood Vaccination Schedules; available at:


http://www.euvac.net/graphics/euvac/vaccination/vaccination.html

JADWAL DOSIS PENGUAT DPT DI EROPA

Masalah pertusis

KASUS PERTUSIS DI INDONESIA, 2006


Fasilitas Kesehatan Puskesmas1 RS-rawat jalan1 RS-rawat inap1 Jumlah kasus 7,185 252 144 Umur (tahun) 1 <1 1-4 5-14 Jumlah kasus1 640 1,840 2,060

Laporan WHO2

3,356

15-44 > 45 Total

1,692 1,349 7,581

Kasus pertusis terutama pada anak-anak dan dewasa muda


1. Depkes. Indonesian Health Profile 2006 : 42 2. WHO. Incidence Series 2010

DISTRIBUSI KASUS PERTUSIS MENURUT GOL.UMUR DI JAWA TIMUR TAHUN 2005 2008 (JULI) GOLONGAN UMUR

N0

TA HUN
<1 TH 1-4 TH 38 5-14 TH 29 15-44 TH 31 >45 TH 34 JML 157 2005 25

2
3 4

2006
2007 2008

18
26 19

33

8
29 24

23
37 23

79
168 172

62 47

14 53

Separuh pada usia yg perlu dosis penguat

PEMBERITAAN ANGKA KEJADIAN PERTUSIS MENINGKAT DI AS

KASUS PERTUSIS DI AS

Rationale for Pertussis Preschool Booster

Immunity to Pertussis is not Lifelong


Perlindungan yang diberikan oleh vaksinasi berkurang dengan bertambahnya waku: Vaksin wholeP: 4-12 tahun Vaksin acellullar P: 6 tahun Belum adanya petanda imunitas serologi yang pasti untuk memperkirakan lamanya imunitas yang dimiliki.

~2 years following infection or vaccination, antibodies barely reach detectable levels HOWEVER, immunity to infection remains

Wendelboe et al. PIDJ, 2005

Rationale for Pertussis Preschool Booster

Infants are Particularly Vulnerable to Pertussis-Related Complications

Infants younger than 1 year are the most vulnerable: 81% of cases related hospitalizations occurred before 4 months (Australia, 2001 national active surveillance) >90% of pertussis-related deaths among infants <12 months (USA, 2000-2004: 92%) Susceptibility in this age group is due to: Fewer transplacental transfer of maternal antibodies due to waning immunity in adults No vaccination before 2 months of age in most primary schedules Protection probably not optimal until some time after completion of primary series Reduction of exposure to B. pertussis is the only way to protect vulnerable infants too young to be (fully) vaccinated
Elliott et al. Pediatr Infect Dis J 2004 CDC. WER, 2006 Hewlett. NEJM, 2005 Beard & Finn. J Public Health Med, 2000

Rationale for Pertussis Preschool Booster

Preschool Booster Provides both Protection to Preschool Children and Herd Immunity to Susceptible Infants

Netherlands, 1998-2005 analysis and comparison pertussis cases registered in the national notification system, hospital registry, and death registry between 1998-2001 (without preschool booster) and 2002-2005 (with preschool booster). Preschool booster

% 80 60 40 20

Changes in incidence of hospitalizations and notifications after preschool pertussis booster introduction (from 1998-2001 to 2002-05) Hospitalizations Notifications

0-5 mo

1-4 yr* 6-11 mo

5-9 yr* 15% 32% 10-19 yr 20-59 yr 60+ yr

0
20%

-20
40%

-40 -60

48% 44%

Age groups

Strong decrease of pertussis burden in the targeted cohorts*:


An estimated 79% effectiveness of booster vaccine

introduced in November 2001 * Both 1-4 and 5-9


age groups contain children eligible for the preschool booster

40% decrease of hospitalization incidence among infants 0-6 months (from 222.5 to 133.6/100,000)
Adapted from de Greef et al. PIDJ, 2008

Rationale for Pertussis Preschool Booster

Preschool Booster Provides Positive Public Health Impact; Potentially Cost-Effective and Cost-Saving

UK cost-effective study of booster vaccination at 4 years of age, over a 5 year period and assuming herd immunity between 35-100% and willingness to pay 110,000 per LYG* reported positive public health impact (21b) : 50% of simulations were cost-effective from Health Care Providers perspective 75% of simulations were cost-effective from Societal perspective In addition, >20% of simulations are cost-saving fro Societal perspective Results based on a dynamic model of pertussis transmission, and presented in terms of herd immunity levels (given high uncertainty of this parameter). Underreporting was also taken into consideration Positive public health impact demonstrated in a study in the Netherlands:

After inclusion of preschool booster in 2001, strong reduction in hospitalizations


48% reduction among children aged 1-4 years 40% reduction among children aged 0-6 months

de Greef et al. PIDJ, 2008 Edmunds et al. Vaccine, 2002 Postma et al. Vaccine, 2009

PERLUNYA PROTEKSI TERHADAP BAYI RENTAN


Penelitian CDC, AS:
774 kasus bayi di 4 negara bagian dari tahun 1999-2002 Wawancara orang tua dari 616 kasus bayi, dapat diidentifikasi 264 sumber penularan

Bisgard et al. PIDJ, 2004

PERLUNYA DOSIS PENGUAT


Cakupan

imunisasi 100% pada bayi dan anak, masih memungkinkan adanya risiko penularan pertusis kelompok bayi rentan. Kelompok bayi rentan tertular pertusis:

Berkurangnya imunitas terhadap pertusis pada usia dewasa, berisiko transfer antibodi transplasental pada ibu berkurang Ada interval waktu tidak dapat diberikan imunisasi, pada:

Mencegah

penularan pada bayi rentan, dianjurkan memberikan dosis penguat imunisasi pertusis pada:

Bayi umur kurang dari 2 bulan Bayi karena suatu hal, tidak dapat tepat waktu melengkapi jadwal imunisasinya.Infants

Anak prasekolah (4-6 tahun) Remaja Dewasa

Forsyth et al. CID, 2004 Forsyth et al. Vaccine, 2007

PERLUNYA PROTEKSI TERHADAP BAYI RENTAN


Angka kejadian pertusis yang harus dirawat 51,4% terjadi karena penularan diantara anak yang tinggal serumah Risiko terjadinya pertusis yang harus dirawat pada bayi, meningkat bila tinggal serumah dengan anak usia sekolah (4,19 kali lebih tinggi)

Hviid et al. Vaccine, 2006

EXPERTS ACKNOWLEDGE NEED FOR PERTUSSIS PRESCHOOL BOOSTER

It is universally acknowledged that even if 100% coverage in infants and children was achieved, infants too young to be [fully] vaccinated would still be vulnerable All countries should consider expanding existing vaccination strategies to include pertussis booster doses in preschool children (4-6 years), to adolescents, and in those specific adults that have the highest risk of transmitting B. pertussis infection to vulnerable infants
Pertussis Initiative Strategy recommendations of the Global

Forsyth et al. CID, 2004 Forsyth et al. Vaccine, 2007

Masalah infeksi tetanus

Rationale for Tetanus Preschool Booster

A Childhood tetanus immunization schedule of 5 doses is recommended. Primary series of 3 doses of DTP3 should be given in infancy (age<1year), with a booster dose of tetanus toxoidcontaining vaccine ideally at age 4-7 years and another booster in adolescence, at age 12-15years) Yet, as vaccination programs are based on combined vaccines (DTP at least), need and timing of booster doses are driven by the weaker immunogens, i.e. pertussis and diphtheria
European Centre for Disease Prevention and Control. ECDC Guidance. Scientific panel on childhood immunization schedule: Diphtheria-tetanuspertussis (DTP) vaccination. 2009.

CIRCULATING VACCINE-DERIVED POLIOVIRUS OUTBREAKS (CVDPVS), 2000-2011

Type 1 (79 cases) Type 2 (478 cases) Type 3 (9 cases)

Rationale for Poliovirus Preschool Booster Ensure High Protection Against both Wild Type and Vaccine Derived Polio

A preschool IPV booster is necessary to maintain long-term immunity against polioviruses IPV is needed in both pre- and post-polio eradication era In the pre-eradication era: Avoid paralytic polio cases associated with Oral Poliovirus Vaccine (OPV) use (in the form of vaccineassociated paralytic polio [VAPP] or vaccine-derive poliovirus [VDPV]) Eliminate remaining wild-poliovirus and circulating VDPVs (cVDPVs) In the post-eradication era Maintain a world free of polio given potential for reappearance of poliovirus and risk of bioterrorism

WHO Position Paper. WER, 2006

Safety and Immunogenicity of the Preschool Booster with TETRAXIM

TETRAXIM

1st licensed in 1998 Licensed in >80 countries ~15 million doses distributed to date

Countries where TETRAXIM is licensed

Licensed under the trade name TETRAVAC in the European Union Sanofi Pasteur. Internal data 2010

TETRAXIM
Vaksin untuk tetanus, difteri, pertusis dan poliomyelitis:

Tetanus toksoid : T Diphtheria toksoid: D 2 komponen Pertusis acellular:PT* FHA*


Reaktogenitas

rendah, mengandung komponen Pertusis acellular 2-komponen aP memiliki imunogenitas dan efektif terhadap pertusis.

40 IU/dosis 30 IU/dosis 25g/dosis 25g/dosis

IPV:

Poliomyelitis virus (inactivated) Tipe 1 Poliomyelitis virus (inactivated) Tipe 2 Poliomyelitis virus (inactivated) Tipe 3

40 DU/dosis 8 DU/dosis 32 DU/dosis

Disesuaikan

Kandungan

dengan kebutuhan pra dan pasca eradikasi polio antigen (IMOVAX Polio) = vaksin IPV pertama yang diterima oleh prakualifikasi WHO

Sanofi Pasteur. TETRAXIM PPI. Data on file Edwards & Decker. In: Vaccines, 5th ed., 2008 Vidor & Plotkin. Hum Vaccin, 2008 Carlsson & Gustafsson. 10-year report. http://www.smittskyddsinstitutet.se/upload/SMI-rapport%20nr%2042008.pdf WHO. WER, 2006 WHO. WER, 2009

IMUNOGENISITAS VAKSIN
Seroprotection/Seroconversion rates following primary immunization at 2,4,6 months of age 100
Seroprotection or Seroconversion rates (%)
92.4 92.5

TETRAXIM (n=219) DTaP (Biken) + IMOVAX Polio (n=223) Historical reference: Pentaxim, France for D,T,PT,FHA

78.4

80 60 40 20 0 D T PT FHA PV1 PV2 PV3


0.01 IU/ml 0.1 IU/ml 4x rise (EU/ml) 8 (1/dil)

IMOVAX Polio, S. Korea for PV1,2,3

Methodology: Open, two-arm, multicenter, randomized, controlled, phase III trial in 442 infants: Group A (n=219): 3 doses of TETRAXIM vaccine at 2,4 and 6months of age Group B (n=223): 3 doses of commercially available separate DTaP and IPV vaccines at 2,4 and 6months of age.

TETRAXIM Induces overall Anamnestic Response when Administered to Preschool-Aged Children

Immunogenicity of Proportion of children exhibiting a 4-fold rise in Ab titers following booster TETRAXIM administered dose with TETRAXIM as Preschool booster in 100 children aged 5-6 years 99.6 100 98 % of children with antibody levels after the 1st and before the 2nd booster doses 95 9 93 (after primary series and 3 80 1st booster with 79 Pentaxim/Pentavac*) 60 (n=69) Strong anamnestic 40 response observed 1 month after preschool 20 booster with TETRAXIM
Proportion with 4-fold rise of Ab titers (%)

0 D T PT FHA PV1 PV2 PV3

Mallet et al. Vaccine, 2004

KIPI LOKAL
100
% of doses followed by reactions

80 60 40 20 0
33 22,1

Solicited local reactions following any dose of vaccine

36,9 27 15,6 8,8

Tenderness

Erythema

Swelling

Methodology: Open, two-arm, multicenter, randomized, controlled, phase III trial in 442 infants: Group A (n=219): 3 doses of TETRAXIM vaccine at 2,4 and 6months of age Group B (n=223): 3 doses of commercially available separate DTaP and IPV vaccines at 2,4 and 6months of age.

KIPI SISTEMIK

Methodology: Open, two-arm, multicenter, randomized, controlled, phase III trial in 442 infants: Group A (n=219): 3 doses of TETRAXIM vaccine at 2,4 and 6months of age Group B (n=223): 3 doses of commercially available separate DTaP and IPV vaccines at 2,4 and 6months of age.

KIPI DOSIS PENGUAT PRA-SEKOLAH

TERIMA KASIH

Manufacture of PEDIACEL Poliovirus


Diphtheria toxin extracted from C. diphtheriae culture Tetanus toxin extracted from C. tetani culture Pertactin, PT, FHA and Fimbriae (AGG 2+3) extracted from B. pertussis culture
Purification Simple detoxification of PT (glutaraldehyde)* and chemical treatment of FHA Adsorption onto

types 1, 2 and 3 propagated on Vero cells

PRP capsular polysacchari de extracted from H. influenzae type b culture

Detoxification (formaldehyde**/ heat) Purification

Detoxification (formaldehyde**/ heat) Purification

Purification Inactivation (formaldehyde** + heat) Blending

Aluminium hydroxide Purified diphtheria toxoid Purified tetanus toxoid Concentrated trivalent polioviruses

Purification, activation and conjugation with concentrated tetanus protein

Adsorbed, purified Pertactin, PT, FHA and Fimbriae (AGG 2+3)

PRP conjugated to tetanus protein

Blending Addition of adjuvant and buffers Filling of sterile syringes

PEDIACEL