A5076039500- Viral gastroenteritis research and epidemiology
- Vaccine Coverage and Hesitancy
- Influenza Virus Research Studies
- SARS-CoV-2 and COVID-19 Research
- Pneumonia and Respiratory Infections
- Bacterial Infections and Vaccines
- COVID-19 Clinical Research Studies
- Respiratory viral infections research
- Salmonella and Campylobacter epidemiology
- Hepatitis Viruses Studies and Epidemiology
- Hepatitis B Virus Studies
- Animal Virus Infections Studies
- Viral Infections and Immunology Research
- Streptococcal Infections and Treatments
- Cervical Cancer and HPV Research
- Monoclonal and Polyclonal Antibodies Research
- Diphtheria, Corynebacterium, and Tetanus
- Public Health and Nutrition
- Diverse Scientific Research Studies
- COVID-19 Prevention and Impact
- Diabetes and associated disorders
- COVID-19 Impact on Reproduction
- Tryptophan and brain disorders
- Child Nutrition and Water Access
- Probiotics and Fermented Foods
PT Bio Farma (Indonesia)
2015-2025
Padjadjaran University
2018
Badan Pengkajian dan Penerapan Teknologi
2015
The WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. development vaccines has moved quickly. In this study, we assessed efficacy, safety, immunogenicity inactivated vaccine.We conducted randomized, double-blind, placebo-controlled trial evaluate immunogenicity, safety SARS-CoV-2 vaccine...
Bio Farma has developed a recombinant protein subunit vaccine (IndoVac) that is indicated for active immunization in population of all ages. This article reported the results phase 3 immunogenicity and safety study Indonesian adults aged 18 years above. We conducted randomized, active-controlled, multicenter, prospective intervention to evaluate IndoVac Participants who were SARS-CoV-2 vaccine-naïve received two doses either or control (Covovax) with 28 days interval between followed up...
BACKGROUND According to the WHO Target Product Profiles for COVID-19 Vaccines, vaccine development should be indicated active immunization in all populations, conjunction with other control measures curtail pandemic. Several RBD-based vaccines are being evaluated and have shown advantages. CoV2-Bio was developed based on wild-type SARS-CoV-2 RBD amino acid sequence, representing residues of spike protein Wuhan-Hu-1 isolate. This study aimed evaluate safety immunogenicity when compared...
Indonesian vaccine producer (PT BIOFARMA), conducted a study to assess the safety and immunogenicity of new COVID-19 candidate. This is based on recombinant subunit protein platform, with SARS-CoV-2 receptor-binding domain (RBD) as its target antigen. The compared candidate's control group vaccine, Sinovac 28 days after administration. was an observer-blinded randomized Phase 1 trial which recruited 175 subjects. subject received 0.5 ml in two doses. subjects were split into five treatment...
Introduction There is a high global incidence of typhoid fever, with an annual mortality rate 200,000 deaths. Typhoid fever also affects younger children, particularly in resource-limited settings endemic countries. vaccination important prevention tool against fever. However, the available polysaccharide vaccines are not recommended for children under 2 years age. A new conjugate Vi-diphtheria toxoid (Vi-DT) vaccine has been developed infant immunization. We aimed to define safety and...
WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine. A prospective, randomized, double blind, multicenter, phase III study Bio Farma vaccine conducted Jakarta Bandung, August 2012 - January Subjects were...
Abstract Background Typhoid fever is commonly found until today, especially in developing countries. It has fatal complications and measures must be taken to reduce the incidence of typhoid. Vaccinations are a key factor prevention. This phase II randomized observer-blind clinical trial on novel Vi-DT conjugate vaccine 200 subjects 12 40 years age. Methods Subjects were screened for eligibility after which blood sample was one dose administered. Investigational used control Vi-PS....
Abstract Background Typhoid fever caused by Salmonella enteric serovar Typhi ( S. ) is a common cause of morbidity in the world. In 2017, 14.3 million cases and paratyphoid occurred globally. School age children between 3 to 19 years old are most affected. Poor sanitation multi drug resistance have increased need for vaccines reduce global burden disease. Based on previous trials, typhoid conjugate longer- lasting protection, higher efficacy, require fewer doses suitable from infancy that...
World Health Organization estimates the annual global incidence of typhoid fever at 11-21 million cases and approximately 128 000 to 161 deaths. The currently used Vi-polysaccharides (Vi-PS) vaccines have been proven be safe efficacious in children 2 years above. However, poor immunogenicity Vi-PS was observed below age. This Phase II study is continuation previously published I that aims evaluate safety a novel Vi-DT Typhoid Conjugate Vaccine (Bio Farma) subjects 6 <24 months.An...
The RV3-BB human neonatal rotavirus vaccine was developed to provide protection from severe disease birth. aim of this study investigate the potential for mutual interference in immunogenicity oral polio (OPV) and RV3-BB. A randomized, placebo-controlled trial involving 1649 participants conducted January 2013 July 2016 Central Java Yogyakarta, Indonesia. Participants received three doses RV3-BB, with first dose given at 0–5 days (neonatal schedule) or ~8 weeks (infant schedule), placebo....
To investigate the effect of influenza vaccination with or without probiotic supplementation on immune response and incidence influenza-like illness (ILI) in elderly.A randomized double-blind, placebo-controlled trial a modified factorial design was conducted 554 healthy elderly subjects aged 67 ± 5.6 (ranging from 60-90) years old Primary Health Care Center (Puskesmas area) Pulo Gadung District East Jakarta. Subjects received either trivalent vaccine placebo at start study, supplement...
The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. aims the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response safety booster dose DTwP-HB-Hib.This was multi-center, open-labeled, prospective, interventional study. Subjects who had received complete vaccine from previous phase III trial recruited this trial....
High rate of influenza infection in children made vaccination strongly recommended for all person aged >6 months Indonesia. Bio Farma Trivalent Influenza HA (Flubio®) vaccine has been used adolescents and adults, resulted increased seroconversion, seroprotection rates geometric mean titer (GMT). However, no data is available regarding its efficacy safety children. This study aimed to assess the immunogenicity Flubio® infants children.This was a phase II, open-labeled, clinical trial...
In this study, we aimed to evaluate the immunological protectivity of infants following four doses bivalent oral polio vaccine (bOPV; Bio Farma), which were given simultaneously with DTwP-Hb-Hib (Pentabio®), along one dose inactivated poliovirus (IPV) at fourth visit. A total 143 newborn who fulfilled inclusion criteria enrolled and completed study. Subjects received first bOPV birth. On days 60, 90 120, was Pentabio®. day IPV also administered. Serum samples for serology analysis collected...
One of the newest strategies developed by Global Influenza Strategy has been to broaden composition current influenza vaccine formulations from trivalent products quadrivalent products. This study aimed assess immunogenicity and safety Quadrivalent HA (QIV) compared with Trivalent (TIV) evaluate three consecutive batches QIV equivalence in Indonesian children adults. was an experimental, randomized, double blind, four arm parallel group bridging involving unprimed healthy adults aged 9-40...
Despite safe and effective WHO prequalified rotavirus vaccines, at least 84 million children remain unvaccinated. A birth dose schedule of the RV3-BB vaccine was reported to be highly efficacious against severe disease in Indonesian infants is under further development PT Bio Farma, Indonesia. The aim develop a starting from that could improve implementation, safety, effectiveness vaccines. multi-site phase I study human neonatal RV3 (Bio Farma) adults, children, neonates Indonesia April...
Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B South-East Asia require maintaining its capacity monovalent production to keep up with both national immunization program global needs. To sustainability vaccine, new bulk is needed be made available. This study aims evaluate immunogenicity safety Bio Farma newly formulated recombinant vaccines, which came from different sources bulk, compared already registered vaccine.An experimental, randomized,...
Vaksin Hib mulai digunakan pada Pogram Imunisasi Nasional sejak tahun 2013 secara bertahap dan di seluruh Indonesia 2014 dalam bentuk vaksin kombinasi DTP/HB/Hib (Pentabio®), yang memberikan kekebalan terhadap difteria, pertusis, tetanus, hepatitis B, Haemophilus influenzae tipe b. Studi ini menilai reaksi sitemik, lokal, serius pascaimunisasi dengan Pentabio®. Sebanyak 4.000 bayi penerima Pentabio®bergabung studi ini. Reaksi timbul dicatat kartu harian oleh petugas sudah dilatih....
Latar belakang. Pemberian vaksin BCG pada bayi masih menjadi kebijakan pemerintah Indonesia dan WHO.Tujuan. Membandingkan keamanan konversi tuberkulin strain Moskow dengan Pasteur.Metode. Tergabung dalam penelitian ini 220 0-1 bulan, kelompok A menerima Pasteur, kelompokB randomisasi tersamar tunggal. Reaksi lokal sistemik yang timbul diamati hingga 30 haripasca imunisasi. Uji dilakukan hari ke-90 pasca imunisasi, pembacaan 48-72 jam kemudian.Hasil. Terdapat 205 anak berhasil menyelesaikan...
Influenza B (Yamagata/Victoria lineage) can cause severe forms of respiratory infection among the pediatric population as well influenza A strains (H3N2/H1N1). Vaccination against all four is required to prevent and outcome. This study first assess immunogenicity Quadrivalent HA vaccine (QIV) ascertain safety children in Indonesia. an open labeled, single arm, bridging clinical involving unprimed healthy 6–35 months age (Group I) 3–8 years II). Subjects on both groups receiving two doses QIV...
Satisfying the needs of national immunization program requires maintaining diphtheria–tetanus–pertussis (DTP)–hepatitis B (HB)–Haemophilus influenza (Hib) production. Therefore, new hepatitis sources are needed. This study aimed to evaluate immunogenicity DTP–HB–Hib vaccine (Bio Farma) that used a different source B. A prospective randomized, double-blind, bridging was conducted. Subjects were divided into two groups with batch numbers. Healthy infants 6–11 weeks age at enrollment immunized...
Objective: Detection of high-risk human papillomavirus (hr-HPV) in urine specimens has been introduced recently and a new local PCR kit developed Indonesia (CerviScan, Bio Farma). The objective this study was to obtain the accuracy hr-HPV DNA testing using Farma) on against gold standard cervical swabs.Method: Adult women (aged 20–50 years) underwent routine general check-up or Pap test were enrolled between July September 2022. Pairs swab obtained from all subjects. HPV-DNA tests performed...
Patients with Type 2 diabetes mellitus (T2DM) and Chronic Kidney Disease (CKD) face an increased risk of morbidity mortality after influenza infection. Several studies have shown that the vaccine effectively prevents in T2DM patients. However, there has been limited research aimed at assessing effectiveness trivalent T2DM–CKD This study to identify Geometric Mean Titers (GMTs), seroprotection, seroconversion, safety, efficacy. open-label clinical trial was conducted AMC Hospital Bandung,...
Background: COVID-19 is one of the most devastating pandemics 21st century. Vaccination effective prevention methods in combating COVID-19, and type vaccine being developed was protein subunit recombinant vaccine. We evaluated efficacy CoV2-IB 0322 Depok, Indonesia. Methods: This study aimed to assess humoral cellular immune response compared an active control (COVOVAX™ Vaccine). A total 120 subjects were enrolled randomized into two groups, with 60 each group. Participants received either...