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Journal : Althea Medical Journal

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.
Factors Affecting Breast Milk Substitute in Pidie Jaya, Aceh, Indonesia Fazira, Frisca; Arisanti, Nita; Gurnida, Dida; Susiarno, Hadi; Azis, Muhammad Alamsyah; Rusmil, Kusnandi
Althea Medical Journal Vol 11, No 2 (2024)
Publisher : Faculty of Medicine Universitas Padjadjaran

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.15850/amj.v11n2.3060

Abstract

Background: Breast milk is the first, main, and best natural food for babies. Breast milk contains various nutrients needed in the process of growth and development of babies. Breastfeeding is a health behavior carried out by mothers. This study aimed to analyze the factors that influence the provision of breast milk substitutes.Methods: This was a quantitative study, using a cross-sectional design. Data collection was carried out from July to August 2022 on 71 mothers who had babies aged up to 6 months at the Bandar Baru Public Health Center, Pidie Jaya, Aceh, Indonesia. Consecutive sampling technique was used. The variables studied included behavior intentions, social support, accessibility of information, personal autonomy, and situational action. Chi-square was used to assess the relationship between independent variables and the dependent variables.Results: Most mothers were aged 20–35 years (70.4%), had junior high school education (78.9%), were unemployed (76.1%), and most did not provide breast milk substitutes (70.4%). Mothers who provided breast milk substitutes was significantly associated with the mother’s intention to give breast milk (p=0.002) and environmental conditions/situations for action (p=0.001). Mothers with low intentions tended to substitute breastmilk (53.8%). Furthermore, the situation of action influenced mothers to provide breast milk substitutes (48.6%).Conclusion: Factors that influence mothers to provide breast milk substitutes are low intention and environmental conditions/situations to act. Therefore, education for mothers to give exclusive breast milk is encouraged. 
Co-Authors - Riyadi -, Burhan Alex Chairulfatah Alex Chairulfatah Ambrosius Purba Amelia Harsanti Anggia Farrah Rizqiamuti, Anggia Farrah Arhana, Arhana Ari Prayitno, Ari Ariani Ariani Armijn Firman Azis, Muhammad Alamsyah Burhan Burhan, Burhan Cissy B. Kartasasmita Cissy B. Kartasasmita Dadang Hudaya Somasetia Deni K Sunjaya Dewi M.D Herawati Dewi Marhaeni Diah Herawati Dida Akhmad Gurnida Djajadiman Gatot Djelantik, I.G.G. Dominicus Husada Dwi Prasetyo Dwi Prasetyo Dwi Prasetyo Dwi Putra, Muhammad Gilang Dwirestuti, Ratna Dzulfikar DLH Eddy Fadlyana Eka Nurfitri, Eka Elsa Puji Setiawati Elsa Setiawati Erwina Sumartini Fanni Hanifa Farid Husin Farid Husin Ferriandis Harsono Firman F Wiranatakusumah Firman Fuad Wirakusumah Frisca Fazira Gaga Irawan Nugraha Gatot Irawan Sarosa Gatot Irawan Sarosa, Gatot Irawan Gladys Gunawan Gurnida, Dida Gutama, Gutama Hadyana Hadyana Hanifah Oswari Hartono Gunardi Hasan Basri Heni Haryani Herry Garna Herry Herman Hindra Irawan Satari Ieva Baniasih Akbar Irvan Afriandi Ismoedijanto Ita Susanti Iwin Sumarman Iwin Suwarman Johanes C Mose Julistio TB Djais Julitasari Sundoro Jusuf Sulaeman Effendi Jusuf Sulaeman Effendi Kartasmita, Cissy B Kevin Gunawan Lelani Reniarti Lina H Soemara Maddepunggeng, Martira Mardiah, Behesti Zahra Mei Neni Sitaresmi Meita Dhamayanti Meita Dhamayanti Meita Dhamayanti Meita Dhamayanti Meita Dhamayanti Mutiara Rahmani Nana Usnawati Nanan Sekarwana Nastiti Kaswandani Nina Herlina Nita Arisanti Novila Sjafri Bachtiar Novilia S Bachtiar Novilia Sjafri Bachtiar Novilia Sjafri Bachtiar Novilia Sjafri Bachtiar Novillia S Bachtiar Padmonodewo, Suminarti Ponpon Idjradinata Prasetya, Taufan Purboyo Solek Purboyo Solek R Dharmayanti Rachmat Gunadi Raihan Raihan, Raihan Ratih Eka Pujasari Retno Puji Astuti Rini Mulia Sari Rodman Tarigan Sahril, Indra Saptawati Bardosono Setyo Handryastuti Siska Bradinda Putri Sudirman Siti Nur Fatimah Sitorus, Rita Sjarif Hidajat Effendi Soedjatmiko Soedjatmiko Soedjatmiko Soenarjati Soedigo Adi Soenarjati Soedigo Adi Solek, Purboyo Sri Rezeki Hadinegoro, Sri Rezeki Sri Rezeki S. Hadinegoro Sri Rezeki S. Hadinegoro, Sri Rezeki S. Sri Utami Suganda Tanuwidjaja Susiarno, Hadi Syafriyal Syafriyal, Syafriyal Syawitri P. Siregar Tatu Septiani Nurhikmah Tetty Yuniati Uni Gamayani, Uni Vanda Elfira Winarno, Gatot N.A Wiryawan Permadi Yogi Agustian Yuni Susanti Pratiwi Yunita Andriani Zakiuddin Munasir Zakiudin Munasir