Palembang, Juli 2009 Objective 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 Immunization remarkably successful very cost-effective Infectious disease Introduction Immunity and Immunization Immunity to contagious disease protect individu from infection. Types of Immunity: Innate immunity Acquired immunity Active immunity organism exposure, vaccine Passive immunity temporary, maternal antibody transmission to fetus, immune globulins or antitoxin Introduction High immunization rates reduced incidence of diphtheria, measles, mumps, polio, rubella, Tetanus, and Haemophilus influenzae type b disease (Table) Introduction Table. Baseline 20 th Century Annual Morbidity and 2004 Morbidity From 10 Diseases With Vaccines Recommended Before 1990 for Universal Use in Children: United States Disease Baseline 20 th Century Annual Morbitiy 2004 Morbidity % Dicrease Smallpox Diphtheria Pertusis Tetanus Poliomielitis Measles Mumps Rubella Congenital rubella syndr H. Influenza type b 48 164 175 885 147 271 1 314 16 316 503 282 152 209 47 745 823 20 000 0 0 25 827 34 0 37 258 10 0 196 100 100 82 97 100 >99 >99 >99 100 >99 Basic Principle of Immunization Produce antibody (immune globulins) Activates limphocyte and macrofag 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 vaccine-preventable 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 Tujuan Imunisasi 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). Vaccine Preventable Disease Disease Type of Organism Incidence (2000) Mode of Transmission Symptoms Complications Diphtheria Gram- positive bacteria 1 Person-to-person direct contact or contact with airborne droplet usually affects children under 15 years. Sore throat, fever. Characterized by formation of yellow-white membranes on tonsils and pharyngeal walls. Potential respiratory distress. Haemophilus influenzae b Gram- negative bacteria 1,398 (invasive disease) Person-to-person contact or droplet. Bacteria may cause otitis media, sinusitis, epiglottis and upper respiratory infections. Bacterial meningitis; most cases of invasive disease occur in children 3 months to 3 years of age. Hepatitis B Virus 8,036 Exposure to infected blood or body fluids. In children primarily prenatally spread. General flu-like symptoms (may be asymptomatic). Liver may be enlarged, dark urine, light stool, jaundice. Symptoms last 4-6 weeks. Chronic hepatitis; cirrhosis; liver cancer. Measles Virus 86 Person-to-person contact or droplet. Flu-like symptoms, high fever (greater that 101), cough, and conjunctivitis. Rash usually starts on the face and spreads to the body. Kopliks spots in the mouth are bluish with very fine red spots. Pneumonia and encephalitis. Persons allergic to eggs may have severe reactions to the vaccine.
Vaccine Preventable Disease Disease Type of Organism Incidence (2000) Mode of Transmission Symptoms Complications Mumps Virus 338 Person-to person contact or droplet. Communicable 6 days before to 9 days after swelling. Most often occurs in children. Low-grade fever, headache, earache, pain and swelling of parotid glands (may be unilateral or bilateral). Swelling lasts about a week. Infrequent complications are encephalitis and meningitis. Orchitis may occur in males who have reached puberty, but sterility is rare. Pertussis Gram- negative bacteria 7,867 Person-to person contact or droplet. Very contagious. Characteristic cough is nonproductive with quick expiratory phase followed by inspiratory "whoop." Small scleral and conjunctival hemorrhages can occur because of severe coughing. Infants younger than 1 year are severely affected. Pneumonia, seizures, and ear infections may occur. Pneumococcus Gram- positive bacteria Not a reportable disease Person-to-person, likely by droplet contact; in many persons are colonized in the upper respiratory tract. Causes otitis media, sinusitis, and invasive bacterial infections. Pneumonia meningitis Polio Virus 0 Direct contact of virus with mouth. Low-grade fever and sore throat (most cases are asymptomatic). Muscle weakness progressing to paralysis in 0.1-2% of cases. May affect any muscle group including limbs and respiratory muscles. Adults may develop postpolio syndrome 30- 40 years after the disease.
Vaccine Preventable Disease Disease Type of Organism Incidence (2000) Mode of Transmission Symptoms Complications Rubella Virus 176 Person-to-person contact or droplet. Communicable 4 days before to 4 days after rash appears. Highly contagious. Mild in adults and young children; macular rash on scalp, trunk, and limbs lasting 1-3 days. Severe complications in early fetal developmentmay result in congenital malformations and death. Vaccine is live so it must NOT be given to pregnant women. Tetanus Neurotoxin produced by an anaerobic, Gram-positive bacteria 35 Exposure of wound to the bacterium. Deep-puncture wounds are at greatest risk. Neonatal tetanus results from contamination of the umbilical stump. Severe generalized muscle spasms.
Varicella Virus 27,382 Person-to-person contact or contact with airborne droplets. Very contagious. Communicable 2 days before to 6 days after vesicles appear. Primarily affects children. Low-grade fever, listlessness. Lesions appear within 2-4 days. Rash has three phases: raised spots, fluid-filled vesicles, and scabs. Rash itches and is found over entire body. Grandparents and older adults should avoid caring for children because they may develop herpes zoster (shingles).
Types of Vaccine BCG OPV Measles MMR Varicella Yellow fever Diphtheria Tetanus Pertusis Cholera Meningococ Pneumococ Hib Typhoid Vi Influenza IPV Rabies Hepatitis B Hepatitis A Bacterial Vaccine Viral Vaccine Heat-sensitive vaccines Freeze- sensitive vaccines Freeze- sensitive vaccines Types of Vaccine Vaccine Live-attenuated or killed microorganisms Inactivated products Specific component Recombinant DNA segmen Types of Vaccine Live attenuated vaccine: Virus atau bakteri liar yang dilemahkan (attenuated) di lab, biasanya dengan pembiakan berulang-ulang Mampu replikasi & menimbulkan kekebalan, tidak menyebabkan sakit Respons imun pejamu ~ infeksi alamiah primer lifelong immunity Types of Vaccine Inactivated vaccine: Bakteri / virus dibiak dibuat tidak aktif (inactivated) Keseluruhan atau fraksi virus / bakteri Basis vaksin fraksi: protein atau polisakarida lifelong immunity (-) perlu booster secara berkala Types of Vaccine Inactivated vaccine: Types: Whole organism Purified protein atau antigen polisakarida dari whole organism Purified antigen yang dihasilkan dari genetically altered organism Chemically modified antigen Vaccine Recomendations Development of recomendations 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 Recomendations Priority: delivering the primary childhood immunization series and protecting adult women and their newborns against tetanus. Vaccine Recomendations Each country has each own policies Indonesia: PPI (Program Pengembangan Imunisasi): BCG, Polio, Hepatitis B, DPT, Campak IDAI (Ikatan Dokter Anak Indonesia): PPI (diwajibkan) Non PPI (dianjurkan) Vaccine Recomendations 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 Vaccination PPI BCG DTP Polio Measles Hepatitis B Recommended Hib MMR Hepatitis A Typhoid Influenza IPD Rotavirus Vaccine Recomendations Immunization schedule in Indonesia recommended by IDAI (non PPI) and government (EPI/PPI) (Table 4 dan Table 5) Vaccine Recomendations Vaccine Recomendations Vaccine Recomendations Vaccine Recomendations Vaccine Recomendations Vaccine Recomendations BCG Vaccine Live attenuated Mycobacterium bovis Administration: < 2 month, repeated BCG not recommended > 3 month, tuberculin test to screen TB infection Store: Reconsituted, 2-8 o C (not in freezer), only 3 hours Dried: 2-8 o C, better in freezer Protected from light BCG Vaccine Contraindication: HIV, immunocompromise, steroid th, immunosuppresive th, radioth, bonemarrow or lymph node, skin infection malignancy, severe malnutrition, high fever, skin infection Protection 8 12 weeks after vaccination Level of protection only 42% (WHO 60-78%) 70% severe TB have BCG scar Adult: positive AFB 25-36% regarding BCG (+) BCG Vaccine BCG Vaccine BCG Vaccine BCG Vaccine Oral Polio Vaccine Live attenuated vaccine Poliomyelitis virus type 1,2,3, Sabin Strain Store: Before opened: -20 o C 2 years; 2 8 o C 6 months After opened: 2 8 o C 7 days Side effect < 1%: headache, diarrhea, or muscle pain VAPP & VDPP 2-4/1 million children immunized: VAPP Oral Polio Vaccine ERAPO: routine immunization coverage , NID/PIN 3 yr, AFP surveilans, mopping up, polio certification Mopping up: Polio (+) stop wild polio virus transmision Oral Polio Vaccine Oral Polio Vaccine Oral Polio Vaccine Inactivated Polio Vaccine (IPV) Imovax, killed polio virus Gut mucosal immunity < VAPP and VDPP risk (-) Store: 2 8 o C 3 years Seroconversion: IPV > OPV (Kenya) Already used in developed country since 2002 When using IPV? Immunization coverage > 90% High AFP coverage (AFP rate 2) Wild polio virus (-) for 3 years DTP Vaccine Diphtheria & tetanus: purified toxoid Pertusis: killed bacteria, adsorbed in Al phosphat Each 1 ml: 40 Lf Td, 24 OU pertusis, 15 Lf TT, Al phosphat 3 mg, thimerosal 0,1 mg Store & transport vaccine in 2 8 o C, should never be frozen Vaccine has been damaged by freezing? shake test Contraindication: Anaphylaxis history Post DTP encephalopathy DTP Vaccine DTP Vaccine Dose: 3x, 2 month, interval 4-6 week Repeat dose: 18-24 month 5-7 year (DTP) 12 year (BIAS) Level of protection: Diphtheria: 1 st dose: 71-94% protection level (<0,01 IU/mL) 3 rd dose: 68-81% protection level Pertusis: 3 rd dose: 65,8-80% protective Tetanus 3 rd dose: 65-80% protective DTP Vaccine DTP Vaccine Tetanus Toxoid Vaccine Tetanus Toxoid Vaccine Goal: Neonatal tetanus elimination Prevent tetanus Tetanus immunization target: > 5x 3 doses (infant) + 2 doses (adult) 4th dose (18-24 month) immunity > 5 yr 5th dose (7 yr) immunity > 10 yr 6th dose (12 yr; TD or TT) immunity > 20 yr Tetanus Toxoid Vaccine Tetanus Toxoid Vaccine Hepatitis B Vaccine Hepatitis B Vaccine Hepatitis B Vaccine Heat marker / Vaccine Vial Monitor Hepatitis B Vaccine Hepatitis B Vaccine Hepatitis B Vaccine Hepatitis B Vaccine Hepatitis B Vaccine Hepatitis B Vaccine Hepatitis B Vaccine DPT-Hep B Combo Vaccine DPT-Hep B Combo Vaccine Heat marker / Vaccine Vial Monitor Measles Vaccine Measles Vaccine Measles Vaccine Measles Vaccine Mumps-Measles-Rubella Vaccine Vaksin Mumps-Measles-Rubella MMR Vaccine Hib Vaccine Prosedur Vaksinasi Penyimpanan & transportasi vaksin Persiapan alat & bahan: untuk vaksinasi & mengatasi gawat darurat Persiapan pemberian: Anamnesis, umur, jarak dengan vaksinasi sebelumnya, riwayat KIPI, indikasi kontra dan perhatian khusus Informed consent: manfaat, risiko KIPI Pemeriksaan fisik Prosedur Vaksinasi Cara pemberian: Dosis, interval Lokasi, sudut, kedalaman Pemantauan KIPI Sisa vaksin, pemusnahan alat suntik Pencatatan Prosedur Vaksinasi Vaksin = produk biologis Rentan/ mudah rusak Mengurangi efektifitas vaksin Prosedur Vaksinasi Faktor-faktor yang mengurangi efektivitas vaksin Jenis Vaksin Paparan suhu yang tidak sesuai Waktu penyimpanan/ batas kadaluwarsa Paparan sinar matahari langsung Penyimpanan dan Distribusi Vaksin bakteri/ virus inaktif: Vaksin yg sangat sensitif thd panas/sinar dibuat berupa bubuk ( freeze-dried powders) Vaksin (yang bukan cairan) dapat disimpan di freezer atau pd +2C sampai +8C Setelah dicampur segara disuntikkan; Vaksin OPV/polio Sabin simpan beku Penyimpanan dan Distribusi JANGAN DIBEKUKAN Vaksin Ajuvan Berupa suspensi yg Ag diadsorbsi oleh garam Al (Al salts) Simpan pada suhu +2 o C to + 8 o C Penyimpanan dan Distribusi Vaksin Sensitif / Labil pada Suhu Ruangan BCG (Bacille Calmette-Gurin) Measles-mumps-rubella (MMR) Oral Polio Vaccine (OPV) Varicella Yellow fever Semua vaksin rekonstitusi Penyimpanan dan Distribusi Diphtheria-tetanus-pertussis Haemophilus influenzae type b Hepatitis B Hepatitis A Vaksin Influenza Pneumococcal (polysaccharide and conjugate) Meningococcal (polysaccharide and conjugate) Semua vaksin kombinasi Pelarut vaksin Penyimpanan dan Distribusi Vaksin yang sensitif pada paparan sinar BCG (Bacille Calmette-Gurin) Vaksin rekonstitusi measles-Mumps-Rubella (MMR) Oral Polio Vaccine (OPV) Semua vaksin akan rusak bila terkena sinar matahari langsung Penyimpanan dan Distribusi Amati adakah perbedaan bentuk vaksin yang terpapar panas atau beku dengan vaksin yang tersimpan baik, selama kurang lebih 30-60 menit CARA MENGETAHUI VAKSIN YANG RUSAK DALAM PENYIMPANAN Penyimpanan dan Distribusi DPT, TT dan hepatitis B dapat rusak karena beku. Dengan mengocok 2 vial secara bersamaan, satu yang diperkirakan sudah pernah beku, dan satu lagi belum, CARA MENGETAHUI VAKSIN YANG RUSAK DALAM PENYIMPANAN Penyimpanan dan Distribusi CARA MENGETAHUI VAKSIN YANG RUSAK DALAM PENYIMPANAN VACCINE VIAL MONITOR (VVM)
Segiempat lebih terang dari lingkaran sekitar. Bila belum kadaluarsa: GUNAKAN vaksin;
Segiempat berubah gelap tetapi lebih terang dari lingkaran sekitar. Bila belum kadaluarsa: SEGERA GUNAKAN vaksin;
Segiempat sama warna dengan lingkaran sekitar. JANGAN GUNAKAN vaksin: Lapor kepada pimpinan;
Segiempat lebih gelap dari lingkaran sekitar. JANGAN GUNAKAN vaksin: Lapor kepada pimpinan. Vaccine Vial Monitor (VVM): Cara menguji vaksin yang sudah terpapar panas >8C VACCINE VIAL MONITOR (VVM) Heat marker / Vaccine Vial Monitor VAKSIN HEPATITIS B VACCINE VIAL MONITOR (VVM) Perubahan warna vaksin polio karena perubahan pH Boleh diberikan VACCINE VIAL MONITOR (VVM) Heat marker / Vaccine Vial Monitor VAKSIN DPT-HB VACCINE VIAL MONITOR (VVM) VAKSIN CAMPAK 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. Cold Chain PENYUNTIKAN DAN PENETESAN VAKSIN Bicara pada bayi dan anak Tentukan lokasi penyuntikan : paha, lengan Posisi bayi / anak : nyaman dan aman Desinfeksi Pegang; peregangan kulit, cubitan PENYUNTIKAN DAN PENETESAN VAKSIN Penyuntikan: dosis, sudut, cara Tetesan: dosis, hati-hati dimuntahkan Penekanan bekas suntikan Membuang alat suntik bekas Penulisan tanggal vaksinasi di kolom yang sudah disediakan Tempat Penyuntikan Tempat Penyuntikan POSISI ANAK KETIKA DIVAKSINASI POSISI ANAK KETIKA DIVAKSINASI POSISI ANAK KURANG AMAN PENETESAN VAKSIN POLIO Kontraindikasi Imunisasi Anafilaksis atau reaksi hipersensitivitas berat KI absolut pemberian dosis vaksin berikutnya Alergi komponen vaksin Vaksinasi Bayi dengan tanda dan gejala AIDS tidak boleh diberikan vaksin BCG dan yellow fever Kontraindikasi Imunisasi KIPI (Kejadian Ikutan Pasca Imunisasi) KIPI KIPI KIPI KIPI KIPI 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 lainatau > 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)