•Equine-like G3P8 the major cause of gastroenteritis during RV3-BB efficacy trial.•The Indonesian equine-like G3P8 strain was genetically similar to Hungarian and Spanish strains.•Equine-like G3P8 ...strain is an emerging cause of gastroenteritis in Indonesia.
The RV3-BB human neonatal rotavirus vaccine aims to provide protection from severe rotavirus disease from birth. The aim of the current study was to characterise the rotavirus strains causing gastroenteritis during the Indonesian Phase IIb efficacy trial.
A randomized, double-blind placebo-controlled trial involving 1649 participants was conducted from January 2013 to July 2016 in Central Java and Yogyakarta, Indonesia. Participants received three doses of oral RV3-BB vaccine with the first dose given at 0–5 days after birth (neonatal schedule), or the first dose given at ∼8 weeks after birth (infant schedule), or placebo (placebo schedule). Stool samples from episodes of gastroenteritis were tested for rotavirus using EIA testing, positive samples were genotyped by RT-PCR. Full genome sequencing was performed on two representative rotavirus strains.
There were 1110 episodes of acute gastroenteritis of any severity, 105 episodes were confirmed as rotavirus gastroenteritis by EIA testing. The most common genotype identified was G3P8 (90/105), the majority (52/56) of severe (Vesikari score ≥11) rotavirus gastroenteritis episodes were due to the G3P8 strain. Full genome analysis of two representative G3P8 samples demonstrated the strain was an inter-genogroup reassortant, containing an equine-like G3 VP7, P8 VP4 and a genogroup 2 backbone I2-R2-C2-M2-A2-N2-T2-E2-H2. The complete genome of the Indonesian equine-like G3P8 strain demonstrated highest genetic identity to G3P8 strains circulating in Hungary and Spain.
The dominant circulating strain during the Indonesian Phase IIb efficacy trial of the RV3-BB vaccine was an equine-like G3P8 strain. The equine-like G3P8 strain is an emerging cause of severe gastroenteritis in Indonesia and in other regions.
During the current Coronavirus Disease 19 (COVID-19) pandemic, regular handwashing and other hand hygiene practices as the primary infection prevention program are highly encouraged. Notwithstanding ...the noticeable benefits in combating viral infection, hand hygiene practice potentially promotes dysbiosis of the skin microbiome. This review aimed to summarize the possible impacts of hand hygiene practices using soap products and alcohol-based hand rubs (ABHR) on the homeostasis of human skin microbiota. We discuss recent findings to provide evidence of the effectiveness of hand hygiene practices in viral infection control, the role of the skin microbiome in human health and the effects of hand hygiene practice on the homeostasis of the skin microbiome. Finally, this review also suggests improving research and practice of hand hygiene in response to the ongoing COVID-19 pandemic.
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 rotavirus disease in Indonesian infants and is under further development at PT Bio Farma, Indonesia. The aim is to develop a rotavirus vaccine starting from birth that could improve the implementation, safety, and effectiveness of vaccines.
A multi-site phase I study of a human neonatal RV3 rotavirus vaccine (Bio Farma) in adults, children, neonates in Indonesia from April 2018 to March 2019. The adult and child cohorts were open-labeled single-dose, while the neonatal cohort was randomized, double-blind, and placebo-controlled three-doses at the age of 0–5 days, 8–10 weeks, and 12–14 weeks. The primary objective was to assess the safety of vaccines with the immunogenicity and vaccine virus fecal shedding as the secondary endpoints in neonates.
Twenty-five adults, 25 children, and 50 neonates were recruited, and all but one in the neonatal cohort completed all study procedures. Three serious adverse events were reported (1 adult & 2 neonates), but none were assessed related to investigational product (IP). The neonatal vaccine group had a significantly higher positive immune response (cumulative seroconverted SNA and IgA) 28 days after three doses than those in the placebo group (72% vs. 16.7%, respectively). The GMT of serum IgA in the vaccine group was significantly higher at post IP dose 1 (p < 0.05) and post IP dose 3 (p < 0.001) compared to the placebo group.
The trial results show that the RV3 rotavirus vaccine (Bio Farma) is well tolerated in all participant cohorts (adults, children, and neonates). Three doses of this vaccine administered in a neonatal schedule were immunogenic. These promising results support further clinical development of the RV3 rotavirus vaccine (Bio Farma).
BACKGROUND: The clinic development of COVID-19 screening is essential during the pandemic.
AIM: This study aimed to explore and elaborate the development process of the Gadjah Mada Electronic Nose ...(GeNose) Center as a pilot project for a COVID-19 university-based clinic in Indonesia.
METHODS: A narrative and explorative study was conducted. Under the university platform, we initiated the GeNose center through training, simulation, and debriefing. Identification of team member recruitment, location, and apparatus development were described using the retrospective approach.
RESULTS: Fifty-one team members were recruited, including person in charge, verifiers, administrative staffs, hotline team, security staffs, and janitors. Standard operating procedures, service system, and safety measures were developed to maintain the quality. Services include the application of COVID-19 protocols, registration and confirmation, education for using the air bag, collecting the air sample, and analysis of samples using the GeNose machine.
CONCLUSION: The GeNose center, a model for screening test, provides services for the screening of COVID-19.
Rotaviruses and noroviruses are the most important viral causes of acute gastroenteritis in children. While previous studies of acute gastroenteritis in Indonesia mainly focused on rotavirus, here, ...we investigated the burden and epidemiology of norovirus and rotavirus disease. Children less than five years of age hospitalized with acute gastroenteritis were enrolled in this study from January to December 2015 at three participating hospitals. Rotavirus was detected by enzyme immunoassay (EIA), followed by genotyping by reverse transcription PCR (RT-PCR). Norovirus genogroups were determined by TaqMan-based quantitative RT-PCR. Among 406 enrolled children, 75 (18.47%), 223 (54.93%) and 29 (7.14%) cases were positive for norovirus, rotavirus and both viruses (mixed infections), respectively. Most cases clinically presented with fever, diarrhea, vomiting and some degree of dehydration. The majority (n = 69/75 92%) of the noroviruses identified belonged to genogroup II, and several genotypes were identified by sequencing a subset of samples. Among 35 samples tested for rotavirus genotype, the most prevalent genotype was G3P8 (n = 30/35 85.6%). Our study suggests that the burden of norovirus diseases in Indonesian children should not be underestimated. It also shows the emergence of rotavirus genotype G3P8 in Indonesia.
Rotavirus is a major cause of diarrhea in Indonesian children. However, rotavirus vaccines have not been introduced in the national immunization program of Indonesia. Understanding the genetic ...diversity and conserved antigenic regions of circulating strains are therefore essential to assess the potential efficacy of rotavirus vaccines. We collected fecal samples from hospitalized children less than 5 years of age with acute diarrhea. Rotavirus genotyping was performed by reverse transcriptase polymerase chain reaction, followed by sequencing of the VP4, VP7, and NSP4 genes of representative strains. Phylogenetic analysis was performed to investigate their relationship with globally circulating strains. Conservational analysis, immunoinformatics, and epitope mapping in comparison to vaccine strains were also performed. The sequence analyses showed that differences of multiple amino acid residues existed between the VP4, VP7, and NSP4 antigenic regions of the vaccine strains and the Indonesian isolates. However, many predicted conserved epitopes with higher antigenicity were observed in the vaccine and Indonesian strains, conferring the importance of these epitopes. The identified epitopes showed a higher potential of rotavirus vaccine to be employed in Indonesia. It could also be helpful to inform the design of a peptide vaccine based on the conserved regions and epitopes in the viral proteins.
Highlight
VP4, VP7, and NSP4 genes of human rotavirus strains circulating in Indonesia were compared with global strains.
The immunoinformatic analysis was performed to investigate the potential antigenic differences between Indonesian and vaccine strains (Rotarix and RotaTeq)
•Both OPV and rotavirus vaccines contain live, attenuated strains that replicate in the gut.•OPV and rotavirus vaccine co-administration has been associated with lower rotavirus immune ...responses.•RV3-BB is a novel human neonatal rotavirus vaccine that provides protection from rotavirus disease from birth.•OPV and RV3-BB co-administration did not reduce immunogenicity of either vaccine.•These findings support the use of RV3-BB where either OPV or IPV is used in the routine schedule.
The RV3-BB human neonatal rotavirus vaccine was developed to provide protection from severe rotavirus disease from birth. The aim of this study was to investigate the potential for mutual interference in the immunogenicity of oral polio vaccine (OPV) and RV3-BB.
A randomized, placebo-controlled trial involving 1649 participants was conducted from January 2013 to July 2016 in Central Java and Yogyakarta, Indonesia. Participants received three doses of oral RV3-BB, with the first dose given at 0–5 days (neonatal schedule) or ~8 weeks (infant schedule), or placebo. Two sub-studies assessed the immunogenicity of RV3-BB when co-administered with either trivalent OPV (OPV group, n = 282) or inactivated polio vaccine (IPV group, n = 333). Serum samples were tested for antibodies to poliovirus strains 1, 2 and 3 by neutralization assays following doses 1 and 4 of OPV.
Sero-protective rates to poliovirus type 1, 2 or 3 were similar (range 0.96–1.00) after four doses of OPV co-administered with RV3-BB compared with placebo. Serum IgA responses to RV3-BB were similar when co-administered with either OPV or IPV (difference in proportions OPV vs IPV: sIgA responses; neonatal schedule 0.01, 95% CI −0.12 to 0.14; p = 0.847; infant schedule −0.10, 95% CI −0.21 to −0.001; p = 0.046: sIgA GMT ratio: neonatal schedule 1.23, 95% CI 0.71–2.14, p = 0.463 or infant schedule 1.20, 95% CI 0.74–1.96, p = 0.448).
The co-administration of OPV with RV3-BB rotavirus vaccine in a birth dose strategy did not reduce the immunogenicity of either vaccine. These findings support the use of a neonatal RV3-BB vaccine where either OPV or IPV is used in the routine vaccination schedule.
•IgA in breast milk was not associated with reduced RV3-BB vaccine take in Indonesia.•IgG titre in cord blood was associated with lower vaccine immunogenicity after one, not three doses of ...vaccine.•RV3-BB vaccine appears to be able to be given with breast-feeding in high rotavirus disease burden settings.
Placental or breast milk maternal antibodies can potentially reduce oral rotavirus vaccine efficacy in developing countries. We aimed to examine the relationship between the level of rotavirus specific immunoglobulin A (IgA) and neutralising antibodies (NA) in colostrum and breast milk and cord IgG, with cumulative vaccine take following one and three doses of oral RV3-BB rotavirus vaccine within a Phase IIb trial in Indonesia.
196 infants received three doses of RV3-BB in a randomized, double-blinded trial, using a neonatal schedule (first dose at 0–5 days of age, n = 61), an infant schedule (first dose at ~ 8 weeks of age, n = 67) or placebo (n = 68). Rotavirus specific IgA and NA in colostrum and breast milk, rotavirus specific cord IgG, Serum IgA and stool excretion were measured.
There was little evidence of an association between IgA in colostrum or breast milk and cumulative vaccine take after three doses in the neonatal or infant groups. In the neonatal group, there was a negative association between IgG titre in cord blood and cumulative vaccine take (odds ratio OR 0.96; 95% confidence interval CI 0.92–1.00; p = 0.03) and serum IgA response (OR 0.94; 95%CI 0.89–0.99; p = 0.02) after one dose of vaccine, which were not evident after three doses in the neonatal or infant groups.
Amongst Indonesian infants we did not find an association between IgA in colostrum or breast milk and vaccine take after 3 doses of RV3-BB vaccine. Maternal rotavirus antibodies in breast milk appear to have minimal impact on RV3-BB vaccine take when administered with a short delay in breast-feeding in settings with a high rotavirus disease burden.
Rotavirus is the major cause of severe diarrhea in children under 5 years old in developed and developing countries. Since improvements in sanitation and hygiene have limited impact on reducing the ...incidence of rotavirus diarrhea, implementation of a vaccine will be a better solution. We conducted an observational study to determine the disease burden and to identify the genotype of circulating rotavirus in Indonesia. Hospitalized children due to acute diarrhea were enrolled from four teaching hospitals in Indonesia. Stool samples were collected based on WHO protocol and were tested for the presence of group A rotavirus using enzyme immunoassay. Then, rotavirus positive samples were genotyped using RT-PCR. Fisher’s Exact tests, Chi square tests and logistic regression were performed to determine differences across hospital and year in rotavirus prevalence and genotype distribution. There were 4235 samples from hospitalized children with diarrhea during 2006, 2009 and 2010. Among them, the rotavirus positive were 2220 samples (52.42 %) and incidence rates varied between hospitals. The G1P8, G1P6, and G2P4 were recognized as the dominant genotypes circulating strains in Indonesia and the proportion of predominant strains changed by year. Our study showed the high incidence of rotavirus infection in Indonesia with G1P8, G1P6, and G2P4 as the dominant strains circulating in Indonesia. These results reinforce the need for a continuing surveillance of rotavirus strain in Indonesia.
INTRODUCTIONAcinetobacter baumannii (A. baumannii) is commonly found as an agent of nosocomial infections and demonstrates a high antibiotic resistance due to its carbapenemase production. The ...objectives of this study were to explore the antibiotic resistance pattern, the presence of OXAs genes and the biofilm-producing capacity of A. baumannii isolated from clinical specimens. METHODSAntibiotics susceptibility testing, detection of OXAs genes and the biofilm-producing capacity were performed using the Kirby Bauer method, polymerase chain reaction (PCR) and adherence quantitative assays, respectively. RESULTSA total of 80 A. baumannii isolates were mainly obtained from sputum and most of them were resistant to antibiotics. All A. baumannii carried blaOXA-51 gene, yet no blaOXA-24 and blaOXA-58 genes were detected. Fourteen (82.4%) of the 17 meropenem resistant isolates carried blaOXA-23 gene, but it was not found in meropenem sensitive isolates. In addition, sixty (75.0%) of 80 isolates were biofilm producers with 2 (2.5%), 16 (20.0%), and 42 (52.5%) isolates were identified as strong, moderate and weak biofilm producers, respectively. CONCLUSIONMost of A. baumannii isolates had a high level of antibiotic resistance and had a capacity to produce biofilm.
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