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Rini Mulia Sari
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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

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (667.057 KB)

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
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

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (576.577 KB)

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
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 
Safety and Preliminary Immunogenicity of Recombinant Hepatitis B (Bio Farma) Vaccine in Adults and Children: A Phase 1 Clinical Trial Fadlyana, Eddy; Tarigan, Rodman; Rusmil, Kusnandi; Sari, Rini Mulia; Kartasmita, Cissy B; Mardiah, Behesti Zahra; Dwi Putra, Muhammad Gilang
Althea Medical Journal Vol 10, No 4 (2023)
Publisher : Faculty of Medicine Universitas Padjadjaran

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.15850/amj.v10n4.3279

Abstract

Background: In order to fulfil the requirements of the national immunization program and sustain the production capacity of the monovalent Hepatitis B vaccine, this study aimed to assess the safety and immunogenicity of the recombinant Hepatitis B Vaccine (Bio Farma) using the new Hepatitis B bulk. Methods: This study was an experimental, randomized, double-blinded, and controlled Phase I clinical trial, with 100 healthy subjects divided into 50 adults and 50 adolescents. Subjects were randomly assigned to receive either the Bio Farma registered Recombinant Hepatitis B Vaccine (group A) or a new source of Hepatitis B bulk (group B). Subjects received one or three doses of vaccine, depending on the baseline anti-Hbs titer. Subjects were given diary cards to record solicited and unsolicited adverse events for 28 days following vaccination. Vaccine immunogenicity was assessed by measuring the level of HBsAg antibody titer elevation.Results: No serious adverse events were reported during clinical trials. The frequencies of adverse events were not significantly different between the two vaccine-randomized groups. The most immediately observed local reaction was local pain, reported by 35.7–42.8% of adults and 24.0–26.3% of adolescents, without any systemic reactions. Seroconversion in adults in group B reached 100% and 78.5% in group A, meanwhile in adolescent subjects in both groups it reached 100%. A substantial increase in geometric mean titer (GMT) was observed in the majority of subjects after immunization.Conclusion: Recombinant Hepatitis B Vaccine with a new source of HBsAg B bulk is safe, well tolerated, and highly immunogenic.
Safety and immunogenicity of the CoV2-Bio in a healthy population aged 18 years and older in Indonesia Maria, Suzy; Olfriani, Ciho; Koesnoe, Sukamto; Sekartini, Rini; Soedjatmiko; Medise, Bernie Endyarni; Yuniar, Irene; Indawati, Wahyuni; Wirahmadi, Angga; Sari, Rini Mulia; Adi, Nuri Purwito; Retnaningdyah, Windri
Medical Journal of Indonesia Vol. 34 No. 1 (2025): March
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.13181/mji.oa.247476

Abstract

BACKGROUND According to the WHO Target Product Profiles for COVID-19 Vaccines, vaccine development should be indicated for active immunization in all populations, in conjunction with other control measures to curtail the pandemic. Several RBD-based COVID-19 vaccines are being evaluated and have shown advantages. CoV2-Bio was developed based on the wild-type SARS-CoV-2 RBD amino acid sequence, representing residues of the spike protein of the Wuhan-Hu-1 isolate. This study aimed to evaluate the safety and immunogenicity of CoV2-Bio when compared to CoronaVac. METHODS This was an observer-blinded, randomized controlled prospective study of safety and immunogenicity of the CoV2-Bio in healthy adult population. A total of 54 healthy participants were randomized to receive either 3 doses of CoV2-Bio or 2 doses of CoronaVac, and 1 dose of placebo, administered 28 days apart. Participants were followed up for safety and immunogenicity. IgG antibody titers (ELISA) and neutralization assay against Wuhan and Delta strains were evaluated at baseline, Days 28, 56, and 84. We assessed seropositive rate, seroconversion, and GMT as parameters. RESULTS Both vaccines were well tolerated and induced good antibody response. The incidence rate and intensity of local and systemic adverse events did not differ between vaccine and control groups. The vaccine group showed a larger proportion of seroconversion (4-fold increase antibody) (87.5% versus 46.2%, p = 0.001) and higher GMT (305.9 AU/ml versus 102.4 AU/ml, p<0.001) when compared to control group. CONCLUSIONS 3 doses of the CoV2-Bio are safe and immunogenic in healthy adult population. 3 doses of the CoV2-Bio COVID-19 vaccine produce a better immunogenicity profile compared to CoronaVac.
Co-Authors - Syafriyal Arhana, Arhana Bernie Endyarni Medise Djelantik, I.G.G. Dwi Putra, Muhammad Gilang Eddy Fadlyana Hindra Irawan Satari, Hindra Irawan Irene Yuniar, Irene Julitasari Sundoro Kartasmita, Cissy B Kusnandi Rusmil Mardiah, Behesti Zahra Maria, Suzy Mei Neni Sitaresmi Novilia Sjafri Bachtiar Nuri Purwito Adi Olfriani, Ciho Retnaningdyah, Windri Rini Sekartini Rodman Tarigan Soedjatmiko Sri Rezeki Hadinegoro, Sri Rezeki Sukamto Koesnoe Syafriyal Syafriyal, Syafriyal Wahyuni Indawati, Wahyuni Wirahmadi, Angga