Novilia Sjafri Bachtiar
Surveillance and Clinical Trial Division, Bio Farma, Bandung, Indonesia

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Titer IgG Pertusis pada Usia Remaja, Dewasa, dan Orang Tua Mempergunakan Metode ELISA dan Mikroaglutinasi Pertusis Bachtiar, Novilia Sjafri; Masria, Sadeli; Husin, Usep Abdullah
Majalah Kedokteran Bandung Vol 43, No 1 (2011)
Publisher : Majalah Kedokteran Bandung

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AbstrakImunisasi pertusis yang hanya diberikan pada masa bayi tidak dapat memberikan proteksi jangka panjang, sehingga terjadi reemerging pertusis. Tujuan penelitian ini adalah untuk mengetahui hubungan usia remaja, dewasa, dan orang tua dengan titer IgG pertusis menggunakan metode enzyme linked immunosorbent assay (ELISA) dan mikroaglutinasi pertusis (MAP). Penelitian observasi analitik dengan rancangan potong lintang ini dilakukan pada 402 subjek yang terdiri atas 134 remaja (12–18 tahun), 187 dewasa (19–49 tahun), dan 81 orang tua (50–64 tahun) di kota Bandung periode 2008–2010. IgG pertusis ditentukan dengan metode ELISA dan MAP. IgG pertusis positif berdasarkan ELISA ditemukan berturut-turut pada 92 (68,7%) remaja, 143 (76,5%) dewasa, dan 72 (88,9%) orang tua (p=0,003). Menggunakan metode MAP persentase IgG pertusis positif pada usia remaja, dewasa, dan orang tua berturut-turut sebesar 27 (20,1%), 9 (4,8%), dan 3 (3,37%), terjadi penurunan dengan bertambahnya usia (p<0,001), menunjukkan proteksi imunisasi tidak dapat bertahan lama. Bila sampel dengan MAP positif dikeluarkan untuk memperoleh titer IgG pertusis akibat infeksi pertusis alamiah maka diperoleh persentase IgG pertusis positif 68,9%. Simpulan, terdapat hubungan antara usia dan titer IgG pertusis positif pada populasi remaja, dewasa, dan orang tua di kota Bandung menggunakan metode ELISA dan MAP. Persentase IgG positif hasil pengukuran ELISA meningkat dengan semakin bertambahnya usia. [MKB. 2011;43(1):10–5].Kata kunci: Bordetella pertussis, enzyme linked immunosorbent assay, IgG, mikroaglutinasiPertussis IgG Titer Percentage in Adolescents, Adults, and Elderly UsingELISA Method and Pertussis MicroagglutinationAbstractPertussis antigen which only given in primary immunization, could not protect for a long period. In some countries whooping cough became an reemerging disease. The objective of this study was to evaluate the correlation between age and percentage of positive IgG pertussis in adolescent, adult, and elderly population using enzyme link immunosorbent assay (ELISA) and microagglutination. This observational analytic with cross sectional study was done on 402 subjects, consisted of 134 adolescents (12–18 years), 187 adults (19–49 years), and 81 elderly (50–64 years) in Bandung, period 2008–2010. Titer of pertussis IgG was measured using ELISA and microagglutinationof pertussis (MAP). The ELISA results showed positive IgG pertussis in 92 (68.7%) adolescent, 143 (76.5%) adults, and 72 (88.9%) elderly (p=0.003). The results of MAP showed positive pertussis IgG in adolescent, adults, and elderly were 27 (20.1%), 9 (4.8%), and 3 (3.37%), respectively, which was decreased with age (p<0.001).If MAP positive samples were excluded from the analysis in ELISA positive samples, which express the IgG pertussis due to contact with circulate B, the pertussis IgG positive was 68.9%. In conclusion, there is a correlation between age and percentage of positive IgG pertussis titer in adolescent, adult, and ederly population in Bandung using ELISA and MAP methods. Positive pertussis IgG by ELISA is increased with age. [MKB. 2011;43(1):10–5].Key words: Bordetella pertussis, enzyme linked immunosorbent assay, IgG, microagglutination
Protektivitas, Reaksi Lokal dan Sistemik Pascaimunisasi dengan Vaksin Campak (Bio Farma) dari Bets Vaksin yang Berbeda pada Anak Sekolah Dasar di Sumatera Barat Sundoro, Julitasari; Bachtiar, Novilia Sjafri; Syafriyal, Syafriyal; Sari, Rini Mulia
Majalah Kedokteran Bandung Vol 47, No 3 (2015)
Publisher : Faculty of Medicine, Universitas Padjadjaran

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Post Marketing Surveillance perlu dilakukan secara berkala untuk memastikan produk yang telah dipasarkan tetap dalam kualitas yang baik. Tujuan penelitian ini adalah mengetahui protektivitas, serta reaksi sistemik dan lokal setelah memperoleh dosis boster vaksin campak dari bets vaksin yang berbeda yang diproduksi pada fasilitas yang berbeda. Penelitian ini menggunakan desain kohort pada anak sekolah dasar di Sumatera Barat. Subjek di Kabupaten Agam  mendapatkan vaksin dengan nomor bets 250210, sedangkan subjek di Kabupaten Limapuluh Kota  vaksin campak bets 253080. Darah diambil sebelum dan 28 hari setelah imunisasi. Pengukuran antibodi menggunakan metode uji netralisasi dengan batas proteksi > 200 mIU/mL. Reaksi lokal dan sistemik dicatat pada kartu harian hingga 28 hari setelah imunisasi. Pengamatan berlangsung dari November 2010 hingga Maret 2011 melibatkan 170 anak di Kabupaten Agam dan 166 anak di Kabupaten Limapuluh Kota. Sebanyak 1,18–1.2% anak mengalami demam pada 3 hari pertama setelah imunisasi dan 1 (0,6%) timbul  pada 14 hari setelah imunisasi dengan instensitas  ringan. Reaksi lokal terbanyak adalah kemerahan pada tempat suntikan (14,46%). Tidak ditemukan kejadian pascaimunisasi serius. Sejumlah 96,99% dan 96,77% anak mempunyai antibodi campak protektif 28 hari pascaimunisasi imunisasi di Kabupaten Agam dan Limapuluh Kota dengan kenaikan GMT dari 329,66 IU/mL menjadi 983,43 IU/mL dan dari 198,00 menjadi 535,10 IU/mL (p=0,000) di Kabupaten Agam dan Limapuluh Kota. Simpulannya adalah kedua bets vaksin campak menunjukkan keamanan dan respons imun yang baik. [MKB. 2015;47(3):144–51]Kata kunci: Campak, Post Marketing Surveillance (PMS), reaksi lokal, reaksi sistemik, vaksinProtectiveness, Local Reaction, and Systemic Reaction after Measles Immunization using Different Batches of Bio Farma Vaccine in Elementary School Students in West Sumatra AbstractPost Marketing Surveillance should be conducted periodically to monitor whether the quality of marketed products is still favorable. The objectives of this study were to evaluate the protectiveness, local reaction, and systemic reaction after receiving booster dose of measles vaccine from different batch numbers. This study was a cohort study on elementary students in West Sumatra. Subjects from Agam District received measles vaccine with  a batch number of 250210 while subjects from Limapuluh Kota District received measles vaccine with a batch number of 253080. Blood samples were collected before and 28 days after immunization. Antibody titers were measured using neutralization assay with a protective level of >200 mIU/mL. Local and systemic reactions were recorded within 28 days after immunization. The observation was held from November 2010 to March 2011 and involved 336 students: 170 students from Agam District and 166 students from Limapuluh Kota District. There were 1.2% students who experienced fever in the first three days after immunization, and 1(0.6%) student experienced mild fever 14 days after immunization. The most common local reaction was redness in the injection site, contributing approximately 14.48%. There were no serious adverse events after immunization. About 96.99% and 96.77% students were protected against measles 28 days after immunization in Agam and Limapuluh Kota Districts with an increase in GMT from 329.66 IU/mL to 983.43 IU/mL and from 198.00 IU/mL to 535.10 IU/mL (p=0.000). In conclusion, both measles vaccine batches show good safety and immune response. [MKB. 2015;47(3):144–51]Key words: Local reaction, measles, Post Marketing Surveillance (PMS), systemic reaction, vaccine DOI: 10.15395/mkb.v47n3.595
Imunogenisitas dan Keamanan vaksin Tetanus Difteri (Td) pada Remaja sebagai salah satu upaya mencegah Reemerging Disease di Indonesia Fadlyana, Eddy; Rusmil, Kusnandi; Garna, Herry; Sumarman, Iwin; Adi, Soenarjati Soedigo; Bachtiar, Novilia Sjafri
Sari Pediatri Vol 15, No 3 (2013)
Publisher : Badan Penerbit Ikatan Dokter Anak Indonesia (BP-IDAI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.14238/sp15.3.2013.141-9

Abstract

Latar belakang. Di Indonesia berpotensi terjadi reemerging disease difteri akibat belum ada program imunisasi ulang yang berkesinambungan pada remaja.Tujuan. Menilai imunogenisitas dan keamanan vaksin tetanus difteri (Td) yang diberikan sebagai imunisasi ulang pada remaja.Metode. Uji klinis randomized double-blind controlled dilakukan terhadap 296 pelajar remaja sehat di kota Bandung, usia 10–18 tahun, pada September 2007–September 2008. Didapatkan 296 remaja sebagai subjek penelitian, dibagi dalam 2 kelompok secara acak sederhana. Kelompok I mendapat vaksin Td 0,5 mL intramuskular. Kelompok II mendapat vaksin TT sebagai kontrol. Pemeriksaan kadar antibodi anti difteri dan anti tetanus dilakukan sebelum dan 1 bulan setelah imunisasi menggunakan teknik enzyme-linked immunosorbent assays (ELISAs). Data keamanan dikumpulkan sampai 1 bulan pasca imunisasi menggunakan buku harianHasil. Konsentrasi antibodi seroproteksi (>0,1 IU/mL) terhadap difteri dan tetanus mencapai 93,2% dan 100,0%. The geometric mean titer (GMT) terhadap difteri meningkat dari 0,0618 IU/mL menjadi 0,7583 IU/mL (p<0,001), dan terhadap tetanus meningkat dari 0,4413 IU/mL ke 14,4054 IU/mL (p<0,001). Nyeri pada tempat suntikan terjadi pada 20,3% kelompok Td dan 18,2% pada TT (p=0,028). Demam >37,5°C hanya terjadi pada sedikit subjek dari kedua kelompok (rentang Td: 0,7-4,7%; rentang TT: 3,4–6,7%). Tidak terdapat reaksi kejadian ikutan pasca imunisasi serius dan dapat ditoleransi dengan baik.Kesimpulan. Imunisasi ulang Td meningkatkan kadar antibodi protektif terhadap difteri dan tetanus, serta aman diberikan pada remaja.
Perbandingan Keamanan dan Konversi Tuberkulin dari Vaksin BCG Strain Moskow dan Vaksin BCG Strain Pasteur pada Bayi Purniti, Ni Putu Siadi; Bachtiar, Novilia Sjafri; Subanda, Ida Bagus; Setyorini, Ayu; Putra, Putu Junara; Gustawan, Wayan; Windiani, IGA Trisna; S, Julitasari; Sari, Rini Mulia
Sari Pediatri Vol 17, No 3 (2015)
Publisher : Badan Penerbit Ikatan Dokter Anak Indonesia (BP-IDAI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.14238/sp17.3.2015.169-74

Abstract

Latar belakang. Pemberian vaksin BCG pada bayi masih menjadi kebijakan pemerintah Indonesia dan WHO.Tujuan. Membandingkan keamanan dan konversi tuberkulin vaksin BCG strain Moskow dengan strain Pasteur.Metode. Tergabung dalam penelitian ini 220 bayi 0-1 bulan, kelompok A menerima vaksin BCG strain Pasteur, dan kelompokB menerima strain Moskow dengan randomisasi tersamar tunggal. Reaksi lokal dan sistemik yang timbul diamati hingga 30 haripasca imunisasi. Uji tuberkulin dilakukan pada hari ke-90 pasca imunisasi, dengan pembacaan 48-72 jam kemudian.Hasil. Terdapat 205 anak berhasil menyelesaikan studi. Pembesaran kelenjar getah bening ditemukan pada kedua kelompok,masing-masing 2 bayi, yang sembuh sendiri tanpa pengobatan. Tidak ditemukan kejadian ikutan pasca imunisasi serius karenavaksin BCG. Jumlah bayi yang mempunyai jaringan parut dan konversi tuberkulin tidak berbeda signifikan, p=0,578 dan p=0,205(p>0.05).Kesimpulan.Vaksin BCG strain Pasteur dan strain Moskow mempunyai profil keamanan dan konversi tuberkulin yang relatifsama.
Immunogenicity and safety of a trivalent inactivated influenza vaccine Fadlyana, Eddy; Rusmil, Kusnandi; Bachtiar, Novilia Sjafri; Gunadi, Rachmat; Sukandar, Hadyana
Paediatrica Indonesiana Vol 51 No 1 (2011): January 2011
Publisher : Indonesian Pediatric Society

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.14238/pi51.1.2011.22-8

Abstract

Background Trivalent inactivated influenza vaccines (TIV) containing antigens of two influenza A strains, A(H1N1) and A(H3N2), and one influenza B strain, are the standard {onnulation for influenza prevention. The vaccines must be updated annually to provide optimal protection against the predicted prevalent strains for the next influenza season.Objective To assess the immunogenidty and safety of the inactivated influenza vaccine (Flubio®) in adolescents and adults, 28 days after a single dose.Methods In this experimental, randomized, single-blind, bridging study, we included 60 healthy adolescents and adults. A single, 0.5 mL dose was administered intramuscularly in the deltoid muscle of the left ann. Blood samples were obtained before and 28 days after immunization. Standardized hemagglutination inhibition (HI) test was used to assess antibody response to influenza antigens.Results From January to February 2010, a total of 60 adolescents and adults enrolled in the study, but two participants did not provide the required blood samples. One hundred percent of the subjects had an anti-influenza titer ≥ 1:40 HI units to all three strains, A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), and B/Brisbane/60/2008 (P=1.000) after immunization. The Geometric Mean Titers (GMT) after immunization increasedfor all strains: A/Brisbane, 76.4 to 992.7, A/Uruguay, 27.6 to 432.1, and B/Brisbane, 19.9 to 312.7. Twenty eight days after immunization, we found a 4 times increase in antibody titers in 75.8% of the subjects for A/Brisbane, 84.5% for A/Uruguay, and 77.6% for B/Brisbane. We also observed that 100% of seronegative subjects converted to seropositive for all 3 strains. All vaccines were well-tolerated. There were no serious adverse events reported during the study.Conclusion In adolescents and adults, the Flubio® vaccine was immunogenic and safe.
Protektivitas, Reaksi Lokal dan Sistemik Pascaimunisasi dengan Vaksin Campak (Bio Farma) dari Bets Vaksin yang Berbeda pada Anak Sekolah Dasar di Sumatera Barat Sundoro, Julitasari; Bachtiar, Novilia Sjafri; Syafriyal, Syafriyal; Sari, Rini Mulia
Majalah Kedokteran Bandung Vol 47, No 3 (2015)
Publisher : Faculty of Medicine, Universitas Padjadjaran

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Abstract

Post Marketing Surveillance perlu dilakukan secara berkala untuk memastikan produk yang telah dipasarkan tetap dalam kualitas yang baik. Tujuan penelitian ini adalah mengetahui protektivitas, serta reaksi sistemik dan lokal setelah memperoleh dosis boster vaksin campak dari bets vaksin yang berbeda yang diproduksi pada fasilitas yang berbeda. Penelitian ini menggunakan desain kohort pada anak sekolah dasar di Sumatera Barat. Subjek di Kabupaten Agam  mendapatkan vaksin dengan nomor bets 250210, sedangkan subjek di Kabupaten Limapuluh Kota  vaksin campak bets 253080. Darah diambil sebelum dan 28 hari setelah imunisasi. Pengukuran antibodi menggunakan metode uji netralisasi dengan batas proteksi > 200 mIU/mL. Reaksi lokal dan sistemik dicatat pada kartu harian hingga 28 hari setelah imunisasi. Pengamatan berlangsung dari November 2010 hingga Maret 2011 melibatkan 170 anak di Kabupaten Agam dan 166 anak di Kabupaten Limapuluh Kota. Sebanyak 1,18–1.2% anak mengalami demam pada 3 hari pertama setelah imunisasi dan 1 (0,6%) timbul  pada 14 hari setelah imunisasi dengan instensitas  ringan. Reaksi lokal terbanyak adalah kemerahan pada tempat suntikan (14,46%). Tidak ditemukan kejadian pascaimunisasi serius. Sejumlah 96,99% dan 96,77% anak mempunyai antibodi campak protektif 28 hari pascaimunisasi imunisasi di Kabupaten Agam dan Limapuluh Kota dengan kenaikan GMT dari 329,66 IU/mL menjadi 983,43 IU/mL dan dari 198,00 menjadi 535,10 IU/mL (p=0,000) di Kabupaten Agam dan Limapuluh Kota. Simpulannya adalah kedua bets vaksin campak menunjukkan keamanan dan respons imun yang baik. [MKB. 2015;47(3):144–51]Kata kunci: Campak, Post Marketing Surveillance (PMS), reaksi lokal, reaksi sistemik, vaksinProtectiveness, Local Reaction, and Systemic Reaction after Measles Immunization using Different Batches of Bio Farma Vaccine in Elementary School Students in West Sumatra AbstractPost Marketing Surveillance should be conducted periodically to monitor whether the quality of marketed products is still favorable. The objectives of this study were to evaluate the protectiveness, local reaction, and systemic reaction after receiving booster dose of measles vaccine from different batch numbers. This study was a cohort study on elementary students in West Sumatra. Subjects from Agam District received measles vaccine with  a batch number of 250210 while subjects from Limapuluh Kota District received measles vaccine with a batch number of 253080. Blood samples were collected before and 28 days after immunization. Antibody titers were measured using neutralization assay with a protective level of >200 mIU/mL. Local and systemic reactions were recorded within 28 days after immunization. The observation was held from November 2010 to March 2011 and involved 336 students: 170 students from Agam District and 166 students from Limapuluh Kota District. There were 1.2% students who experienced fever in the first three days after immunization, and 1(0.6%) student experienced mild fever 14 days after immunization. The most common local reaction was redness in the injection site, contributing approximately 14.48%. There were no serious adverse events after immunization. About 96.99% and 96.77% students were protected against measles 28 days after immunization in Agam and Limapuluh Kota Districts with an increase in GMT from 329.66 IU/mL to 983.43 IU/mL and from 198.00 IU/mL to 535.10 IU/mL (p=0.000). In conclusion, both measles vaccine batches show good safety and immune response. [MKB. 2015;47(3):144–51]Key words: Local reaction, measles, Post Marketing Surveillance (PMS), systemic reaction, vaccine DOI: 10.15395/mkb.v47n3.595
The Safety of Haemophilus influenzae Type b/Polyribosylribitol phosphate-Tetanus (Hib/PRP-T) Vaccine, Phase I Study Rusmil, Kusnandi; Fadlyana, Eddy; Gunadi, Rachmat; Bachtiar, Novilia Sjafri; Hadyana, Hadyana
International Journal of Integrated Health Sciences VOL 3, NO 2, September (2015)
Publisher : International Journal of Integrated Health Sciences

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Objective: To assess the safety and immunogenicity of Haemophilus influenzae type b/polyribosylribitol phosphate-Tetanus (Hib/PRP-T) liquid vaccine in healthy adults.Methods: An open label prospective intervention phase I study was conducted in Dr. Hasan Sadikin General Hospital from November to December 2010. Healthy adults aged 18−40 were eligible to participate. Participants received one dose of Hib/PRP-T liquid vaccine. Blood samples were taken before, 4 days and 1 month after vaccination. For a 28-day period following vaccination, solicited adverse events were collected in the subjects’ diary and assessed afterward. Results: Neither local reactions nor immediate systemic events were observed during a 30-minute period after immunization. There were no serious local or systemic reactions in this study. All of local and systemic reactions observed were slight, transient, self-limiting in time, without lasting for more than 72 hrs. after the administration of the vaccine, and resolved without any medical intervention. Hematologic and biochemical indices before and 4 days after vaccination showed in normal limits. All subjects (100%) reached protective levels of antibodies (seroprotectivity) against Hib. All subjects demonstrated antibodies performing high bactericidal activities 1 month after immunization. Conclusions: This study demonstrated that liquid Hib/PRP-T vaccine is highly immunogenic and have a beneficial safety when administered to healthy adults. Keywords: Adults, Hib vaccines, immunogenicity, safety DOI: 10.15850/ijihs.v3n2.584
Profil Keamanan setelah Pemberian Dosis Primer Vaksin Pentabio® pada Bayi di Indonesia Sundoro, Julitasari; Rusmil, Kusnandi; Sitaresmi, Mei Neni; Arhana, Arhana; Djelantik, I.G.G.; Hadinegoro, Sri Rezeki; Satari, Hindra Irawan; Syafriyal, Syafriyal; Bachtiar, Novilia Sjafri; Sari, Rini Mulia
Majalah Kedokteran Bandung Vol 49, No 2 (2017)
Publisher : Faculty of Medicine, Universitas Padjadjaran

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.15395/mkb.v49n2.1052

Abstract

Vaksin Hib mulai digunakan pada Pogram Imunisasi Nasional sejak tahun 2013 secara bertahap dan di seluruh Indonesia mulai tahun 2014 dalam bentuk vaksin kombinasi DTP/HB/Hib (Pentabio®), yang memberikan  kekebalan terhadap difteria, pertusis, tetanus, hepatitis B, dan Haemophilus influenzae tipe b. Studi ini menilai reaksi sitemik, reaksi lokal, dan reaksi yang serius pascaimunisasi dengan Pentabio®. Sebanyak 4.000 bayi penerima vaksin Pentabio®bergabung dalam studi ini. Reaksi yang timbul dicatat pada kartu harian oleh petugas yang sudah dilatih. Vaksin Pentabio®yang diamati pada PMS ini menggunakan vaksin rutin dari Program Imunisasi Nasional dalam waktu pengamatan 28 hari di empat propinsi, yaitu Nusa Tenggara Barat, Bali, Yogyakarta, dan Jawa Barat pada periode Mei–Desember 2014. Sebanyak 3.978 data dapat dianalisis karena 22 di antaranya tidak memberikan informasi yang valid. Reaksi sistemik yang paling banyak timbul adalah demam 0,85% pada 30 menit pertama, dan meningkat menjadi 14,03% pada satu hari pascaimunisasi, kemudian sembuh pada hari berikutnya. Reaksi lokal yang paling sering timbul adalah nyeri pada tempat suntikan pada 67,6% subjek pada 30 menit setelah imunisasi, dan meningkat menjadi 87,23% pada 1 hari pascaimunisasi namun sembuh pada hari berikutnya. Mayoritas nyeri yang timbul adalah kategori ringan. Tidak ditemukan kejadian ikutan pascaimunisasi serius selama pengamatan. Simpulan, reaksi lokal dan sistemik pascaimunisasi dengan Pentabio® dapat ditoleransi pada bayi. [MKB. 2017;49(2):86–93]   Kata kunci: Bayi, Pentabio®, post marketing surveillance, reaksi lokal, reaksi sistemik   Safety Profile Following Pentabio® Primary Dose Vaccination in Indonesian Infants   Since 2013 Indonesian Expanded Program on Immunization (EPI) has  graduallyincluded Hib vaccine into routine EPI schedule in four provinces and has established the vaccine inclusion in the the nationwide program through integration of Hib vaccine into existing DTP/HB vaccine in the form of pentavalent vaccine (DTP/HB/Hib). Pentabio® vaccine is given to provide protection against diphtheria, tetanus, pertussis, hepatitis B, and Hib infection in infants and children under 5 years old.  The objective of this study was to assess the systemic reactions, local reactions, and any serious adverse event after Pentabio® immunization. About 4,000 infants were involved in this study. Systemic and local reactions were recorded on diary cards by trained health care provider. Pentabio® vaccines in this PMS were obtained from the National Immunization Program within 28 days of observation in four provinces, West Nusa Tenggara, Bali, Yogyakarta, and West Java in May–December 2014. In total, 3,978 infants were analyzed, while the other 22 forms were not included due to incomplete information. The most common systemic reaction was fever, found in 0.85% of the subjects at 30 minutes after injection, and increased to 14.03% at day 1 (one) after immunization, which disappeared the day after. The most common local reaction was pain, which was found in 67.6% subjects at 30 minutes after injection, and increased to 87.23% at day 1 (one) after immunization to disappear the day after. The intensity of the pain was mostly mild. No serious adverse event following immunization found during observation. [MKB. 2017;49(2):86–93]   Key words: Infants, local reactions, Pentabio®, post marketing surveillance, systemic reactions 
Protektivitas, Reaksi Lokal dan Sistemik setelah Imunisasi dengan Vaksin Td pada Anak Sekolah Dasar di Indonesia Sundoro, Julitasari; Bachtiar, Novilia Sjafri; Syafriyal, -; Sari, Rini Mulia
Majalah Kedokteran Bandung Vol 46, No 3 (2014)
Publisher : Faculty of Medicine, Universitas Padjadjaran

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Abstract

penelitian ini adalah untuk mengetahui reaksi dan respon imun setelah memperoleh 1 dosis vaksin Td. Penelitian ini merupakan Post Marketing Surveillance, dengan desain kohort pada anak sekolah dasar di Jawa Timur. Reaksi lokal dan sistemik dicatat pada kartu harian hingga 28 hari setelah imunisasi. Darah diambil sebelum dan 28 hari setelah imunisasi. Pengukuran antibodi menggunakan metode uji double antigen ELISA, dengan batas proteksi 0,01 IU/mL baik untuk anti-tetanus maupun anti-difteria. Pengamatan yang berlangsung dari Oktober 2010 hingga April 2011 ini melibatkan sebanyak 2978 anak sekolah dasar, termasuk 159 anak untuk kelompok respon imun. Sebanyak 1,18%-2,45% anak mengalami demam dengan instensitas mayoritas ringan. Reaksi lokal terbanyak adalah nyeri pada 30 menit setelah imunisasi 62,49% naik menjadi 83,38% pada hari ke-1, dan menurun pada hari berikutnya dengan intensitas mayoritas adalah ringan. Tidak ditemukan kejadian pasca imunisasi serius. Sebanyak 98,11% dan 99,37% anak terlindungi terhadap difteria dan tetanus dengan Geometric Mean Titer 1,2280 IU/mL (p=0,000) untuk anti-difteria dan 10,6068 IU/mL (p=0,009) untuk anti-tetanus. Simpulan, dari hasil pengamatan menunjukkan bahwa vaksin ini bersifat imunogenik dan aman setelah pemberian 1 (satu) dosis pada anak sekolah dasar.Kata kunci: Post Marketing Surveillance (PMS), reaksi lokal, reaksi sistemik, vaksin TdProtectivity, Local and Systemic Reactions Following Td Vaccination among Elementary School Students in IndonesiaTd vaccine is given to provide protection to tetanus and diphtheria in children 7 years of age or above. The objectives of this study are to evaluate the reactions and immune response after 1 dose of Td vaccine. This study is a post marketing surveillance with a cohort design among elementary school students in East Java. Systemic and local reactions were recorded in diary cards untill 28 days after immunization. Blood was collected before and 28 days after immunization. Antibody titers were measured using double antigen ELISA with cut off protection rate >0,01 IU/ml. Observation were done between October 2010 to April 2011 which involved 2978 included 159 subjects for immune response group. In this study, fever was occured in 1,18%-2,45% subjects at the first three days with mild in intensity and resolved immediately without any medication. The most often local reaction was pain in 62,49% subjects at 30 minutes after injection, and increased to 83,38% at day 1 after immunization, and decreased the day after, with the intensity mostly were mild. No serious adverse reactions was found. 98,11% and 99,37% subjects were protected to diphtheria and tetanus, with the Geometric Mean Titer 1,2280 IU/mL (p=0,000) for anti-diphtheria and 10,6068 IU/mL (p=0.009) for anti-tetanus. In conclusion, Td vaccine is safe and immunogenic after 1 (one) dose in school age children, and there were no serious adverse event. Keywords: local reactions, post marketing surveillance (PMS), systemic reactions, Td vaccine DOI: 10.15395/mkb.v46n3.315
The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine Bachtiar, Novilia Sjafri; Rusmil, Kusnandi; Sudigdoadi, Sunarjati; Kartasasmita, Cissy B; Hadyana, Hadyana
Paediatrica Indonesiana Vol 57 No 3 (2017): May 2017
Publisher : Indonesian Pediatric Society

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (887.392 KB) | DOI: 10.14238/pi57.3.2017.129-37

Abstract

Background Haemophilus influenzae type b (Hib) causes infection with predominant manifestations of pneumonia, meningitis, and other invasive diseases, occurring primarily in children aged under 2 years, particularly in infants.  The World Health Organization (WHO) and Indonesian Technical Advisory Group for Immunization recommend to include the Hib vaccine into the national immunization program. The newly developed DTwP-HB-Hib combination vaccine is anticipated to be the preferred choice for Hib vaccine introduction; it is efficient, simple, and has higher coverage.Objective To evaluate the immunogenicity and safety of a new, combined Bio Farma DTwP-HB-Hib vaccine, compared to the registered Hib monovalent vaccine given simultaneously with the local DTwP-HB vaccine, when used as the primary vaccination of Indonesian infants.Methods A prospective, randomized, open-label, phase II study was conducted on the DTwP-HB-Hib vaccine compared to the Hib (registered) vaccine given simultaneously with the DTwP-HB vaccine, in Bandung from July 2011 to January 2012. Infants were serially vaccinated at 6-11, 10-15, and 14-19 weeks. Serological assessments were done prior to the first vaccine dose and 28 days after the third dose. Safety was assessed from the time of first injection until 1 month after the last injection.Results Of 220 healthy infants enrolled, 211 completed the study, with 105 receiving the combined vaccine and 106 the two separate vaccines. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the two methods of administration. No serious adverse events were considered to be related to the vaccines. In the DTwP-HB-Hib primary-vaccination group, at least 98% of the infants reached protective levels of antibodies (seropositivity) against the antigens employed in the vaccines while 96% in the control group.Conclusion The DTwP-HB-Hib combined vaccine is immunogenic and safe, as well as comparable to the Hib vaccine given simultaneously with to the DTwP-HB vaccine.