Immunogenicity Assessment of the SARS-CoV-2 Protein Subunit Recombinant Vaccine (CoV2-IB 0322) in a Substudy of a Phase 3 Trial in Indonesia.

BACKGROUND: COVID-19 is one of the most devastating pandemics of the 21st century. Vaccination is one of the most effective prevention methods in combating COVID-19, and one type of vaccine being developed was the protein subunit recombinant vaccine. We evaluated the efficacy of the CoV2-IB 0322 vaccine in Depok, Indonesia. METHODS: This study aimed to assess the humoral and cellular immune response of the CoV2-IB 0322 vaccine compared to an active control vaccine (COVOVAX™ Vaccine). A total of 120 subjects were enrolled and randomized into two groups, with 60 subjects in each group. Participants received either two doses of the CoV2-IB 0322 vaccine or two doses of the control vaccine with a 28-day interval between doses. Safety assessments were conducted through onsite monitoring and participant-reported adverse events. Immunogenicity was evaluated by measuring IgG anti-RBD SARS-CoV-2 and IgG-neutralizing antibodies. Cellular immunity was assessed by specific T-cell responses. Whole blood samples were collected at baseline, 14 days, 6 months, and 12 months after the second dose for cellular immunity evaluation. RESULTS: Both vaccines showed high seropositive rates, with neutralizing antibody and IgG titers peaking 14 days after the second dose and declining by 12 months. The seroconversion rate of anti-S IgG was 100% in both groups, but the rate of neutralizing antibody seroconversion was lower in the CoV2-IB 0322 vaccine group at 14 days after the second dose (p = 0.004). The CoV2-IB 0322 vaccine showed higher IgG GMT levels 6 and 12 months after the second dose (p < 0.001 and p = 0.01). T-cell responses, evaluated by IFN-γ, IL-2, and IL-4 production by CD4+ and CD8+ T-cells, showed similar results without significant differences between both groups, except for %IL-2/CD4+ cells 6 months after the second dose (p = 0.038). CONCLUSION: Both vaccines showed comparable B- and T-cell immunological response that diminish over time.

Prevalence, Risk Factors, and Pediatrician Awareness of Infant Dyschezia in Indonesia.

Purpose: This study aimed to evaluate the prevalence and risk factors of infant dyschezia as well as pediatrician awareness regarding this disease in Indonesia. Methods: This is a two-part cross-sectional study, which was divided into study A and B. Study A: Parents whose infants were under 9 months old and attended well-baby clinics were recruited at two randomly selected primary health centers. Parents also provided information on the infant's previous medical history, and socio-demographic and family details. The Rome IV criteria was translated and validated to be used for diagnosis of infant dyschezia. Study B: Randomly selected pediatricians were surveyed by using a questionnaire to evaluate their knowledge regarding infant dyschezia. Results: The prevalence of infant dyschezia based on the result of this study was 11.8%. Three risk factors had a significant relationship with infant dyschezia i.e., the number of children in the family (odds ratio [OR], 5.619; 95% confidence interval [CI], 2.194-14.390; p<0.001), complementary food diet (OR, 4.238; 95% CI, 1.902-9.443; p<0.001), and social-emotional disturbance (OR, 5.670; 95% CI, 2.550-12.609; p<0.001). The percentage of pediatricians correctly diagnosed infant dyschezia was 71.5%. Most pediatricians agreed that they did not perform any diagnostic testing (79.7%) and only provided education in cases of infant dyschezia (58.5%). Conclusion: The prevalence of infant dyschezia identified in our study was higher than that in other neighboring Asian countries, with the highest prevalence observed in infants 7-9 months old. Being an only child, receiving complementary food diet, and sociao-emotional disturbances were significant risk factors of infant dyschezia.

The characteristics of foreign bodies aspirated by children across different continents: A comparative review.

BACKGROUND: Foreign body aspiration (FBA) is a common issue in pediatric emergencies, with regional variations. Various cultures and foods, parents' and physicians' inadequate experience, and lack of bronchoscopy equipment are some attributable factors in the regional variation of FBA. AIM: To more accurately represent the demographic characteristics of aspirated foreign bodies (FBs) across various continents, this review attempted to provide organized information based on the reviewed articles. METHODOLOGY: A search was conducted in PubMed/PubMed Central, EMBASE, and google scholar. From the 36 included articles, information on age, gender, bronchoscopy type, type of FB, location, history of choking, and time elapsed between aspiration and admission were extracted. RESULTS: A total of 14,469 cases were evaluated. According to the findings, children under two accounted for more than 75% of FBAs. Nuts and seeds were the most common FBs in most countries, whereas plastic and metal objects had higher rates in Brazil, and calcified objects were more prevalent in Thailand. The right bronchus was the most frequent location, and rigid bronchoscopy was the most often utilized type of bronchoscope. In addition, a significant percentage of patients were referred to the emergency rooms in the first 12-24 h following the aspiration incident. Moreover, Asian patients reported more choking history, and Europeans had fewer witnesses of FBA. CONCLUSIONS: There is a lack of standardized reporting systems and organized guidelines in pediatric FBA. To select the ideal time for endoscopies and create educational programs, a collaboration between experienced researchers, pediatric pulmonologists, radiologists, and otolaryngologists is required.

Evaluation of Pediatric COVID-19 Screening Process in a Tertiary Hospital of Indonesia.

Objectives: To identify parameters that can improve the effectiveness of COVID-19 screening in the pediatric population according to the demographic, clinical, and epidemiological characteristics of pediatric patients screened for COVID-19 at our hospital. Methods: A cross-sectional study of suspected and confirmed pediatric patients (0-18 years old) with COVID-19 using data from the electronic medical records of Dr. Cipto Mangunkusumo Central Hospital from March to December 2020. Results: From 1,018 data of suspected COVID-19 pediatric patients, there were 94 (9.2%) confirmed cases of COVID-19. The proportions of children with travel history (p=0.022), positive contact history (p < 0.001), fever ≥38°C (p=0.034), cough (p=0.038), and abdominal pain (p=0.022) were significantly higher in the confirmed COVID-19 group compared to the non-COVID-19 group. Conclusions: A majority of the confirmed COVID-19 pediatric patients have travel and positive contact history, along with symptoms of fever, cough, and abdominal pain. However, these are nonspecific symptoms that may also be misdiagnosed as other diseases. Improving access and turnaround time of the RT-PCR test is mandatory, as no specific screening variables have been identified.

Clinical Features of Multisystem Inflammatory Syndrome in Children Associated with COVID-19 in Indonesia.

BACKGROUND: While the number of cases of multisystem inflammatory syndrome in children (MIS-C) is increasing, reported cases in Asian countries are still low, particularly in Indonesia. This study aimed to describe the characteristics of patients with MIS-C in a tertiary referral hospital in Indonesia. METHODS: This is a cross-sectional study with collected data of patients with MIS-C admitted to Dr. Cipto Mangunkusumo from March 2020 to April 2021. RESULTS: The first case of MIS-C was detected 5 months after the first reported coronavirus disease 2019 case in Indonesia. Thirteen patients out of 158 positive admitted patients for COVID-19 were diagnosed with MIS-C during the study period. Of these 13 patients, 2 patients (15%) had a fatal outcome. Subjects were predominantly male, and the median age was 7.58 years (IQR 12.3) years. Most patients required mechanical ventilation (7 out of 13 patients) and intubation (8 out of 13 patients). Patients who needed intubation usually needed mechanical ventilation. All inflammatory markers, white blood cells, neutrophil counts, and all coagulation factor parameters (except for normal prothrombin time and activated partial prothrombin time) were elevated. The median time to MIS-C diagnosis was 2 days in the survivor group (n = 11) compared to 8.5 days in the non-survivor group (n = 2). Compared to the non-survivor group, those who survived spent more days in the hospital, received vasopressors earlier, and did not require mechanical ventilation as early as the non-survivors. CONCLUSIONS: Our work highlights the differences in MIS-C clinical course, treatment, and clinical outcomes between the two groups.

Mortality in children with positive SARS-CoV-2 polymerase chain reaction test: Lessons learned from a tertiary referral hospital in Indonesia.

BACKGROUND: The incidence of coronavirus disease 2019 (COVID-19) is still increasing rapidly, but little is known about the prevalence and characteristics of fatal cases in children in Indonesia. This study aimed to describe the characteristics of children with COVID-19 with fatal outcomes in a tertiary referral hospital in Indonesia. METHODS: This cross-sectional study used data collected from the medical records of patients with COVID-19 admitted to Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia from March to October 2020. RESULTS: During the study period, 490 patients were admitted and diagnosed with suspected and probable COVID-19. Of these patients, 50 (10.2%) were confirmed to have COVID-19, and 20 (40%) had a fatal outcome. The fatality rate was higher in patients aged ≥10 years, categorized with severe disease upon admission, PaO2/FiO2 ratio ≤300 mmHg and chronic underlying diseases. The most common clinical manifestations were generalized symptoms, while acute respiratory distress syndrome (8/20) and septic shock (7/20) were the two most common causes of death. Increased procalcitonin, D-dimer, lactate dehydrogenase and presepsin levels were found in all fatal cases. One patient met the criteria of multisystem inflammatory syndrome in children. CONCLUSION: Our work highlights the high mortality rate in paediatric patients with positive SARS-CoV-2 polymerase chain reaction test. These findings might be related to or co-incided with COVID-19 infection. Further studies are needed to improve understanding of the role of severe acute respiratory syndrome coronavirus-2 in elaborating the mechanisms leading to death in children with comorbidities.

BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial.

BACKGROUND: A growing body of evidence shows the short-term benefits of breastfeeding, which include protection against infections, allergies, and lung diseases. However, evidence on the long-term benefits of breastfeeding is scarce and often conflicting. The BReastfeeding Attitude and Volume Optimization (BRAVO) trial is designed to study the effect of breastfeeding on early signs of later chronic diseases, particularly cardiovascular, respiratory, and metabolic risks later in life. In addition, the effectiveness of breastfeeding empowerment in promoting breastfeeding will also be evaluated. METHODS/DESIGN: This study is an ongoing randomized trial in Jakarta, Indonesia, that began in July 2012. Pregnant women are being screened for their breastfeeding plan in the third trimester, and those with low intention to breastfeed are randomly allocated to either receiving an add-on breastfeeding-optimization program or usual care. Primary outcomes include breastfeeding rate, lung function, and blood pressure during the first year of life and vascular/cardiac characteristics, which will be measured at the age of 4 to 5 years. Child growth and infection/illness episodes are measured, whereas cognitive testing is planned for the children at 5 years of age. DISCUSSION: To date, 784 women (80 %) have been randomized of the 1,000 planned, with satisfactory completeness of the 1-year follow up (90.1 %). Included mothers are of lower socioeconomic status and more often have blue-collar jobs, similar to what was observed in the pilot study. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01566812 . Registered on 27 March 2012.