Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial.

BACKGROUND: 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 of the phase 3 immunogenicity and safety study in Indonesian adults aged 18 years and above. METHODS: We conducted a randomized, active-controlled, multicenter, prospective intervention study to evaluate the immunogenicity and safety of IndoVac in adults aged 18 years and above. Participants who were SARS-CoV-2 vaccine-naïve received two doses of either IndoVac or control (Covovax) with 28 days interval between doses and were followed up until 12 months after complete vaccination. RESULTS: A total of 4050 participants were enrolled from June to August 2022 and received at least one dose of vaccine. The geometric mean ratio (GMR) of neutralizing antibody at 14 days after the second dose was 1.01 (95 % confidence interval (CI) 0.89-1.16), which met the WHO non-inferiority criteria for immunobridging (95 % CI lower bound > 0.67). The antibody levels were maintained through 12 months after the second dose. The incidence rate of adverse events (AEs) were 27.95 % in IndoVac group and 32.15 % in Covovax group with mostly mild intensity (27.70 %). The most reported solicited AEs were pain (14.69 %) followed by myalgia (7.48 %) and fatigue (6.77 %). Unsolicited AEs varied, with each of the incidence rate under 5 %. There were no serious AEs assessed as possibly, probably, or likely related to vaccine. CONCLUSIONS: IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax. (ClinicalTrials.gov: NCT05433285, Indonesian Clinical Research Registry: INA-R5752S9).

Incidence of moral hazards among health care providers in the implementation of social health insurance toward universal health coverage: evidence from rural province hospitals in Indonesia.

Objective: To identify the incidence of moral hazards among health care providers and its determinant factors in the implementation of national health insurance in Indonesia. Methods: Data were derived from 360 inpatient medical records from six types C public and private hospitals in an Indonesian rural province. These data were accumulated from inpatient medical records from four major disciplines: medicine, surgery, obstetrics and gynecology, and pediatrics. The dependent variable was provider moral hazards, which included indicators of up-coding, readmission, and unnecessary admission. The independent variables are Physicians' characteristics (age, gender, and specialization), coders' characteristics (age, gender, education level, number of training, and length of service), and patients' characteristics (age, birth weight, length of stay, the discharge status, and the severity of patient's illness). We use logistic regression to investigate the determinants of moral hazard. Results: We found that the incidences of possible unnecessary admissions, up-coding, and readmissions were 17.8%, 11.9%, and 2.8%, respectively. Senior physicians, medical specialists, coders with shorter lengths of service, and patients with longer lengths of stay had a significant relationship with the incidence of moral hazard. Conclusion: Unnecessary admission is the most common form of a provider's moral hazard. The characteristics of physicians and coders significantly contribute to the incidence of moral hazard. Hospitals should implement reward and punishment systems for doctors and coders in order to control moral hazards among the providers.

Effectiveness of the Elderly Caring Model as an Intervention to Prevent the Neglect of the Elderly in the Family.

BACKGROUND: The increasing number of older people is racing against diseases and problems that accompany the elderly, so it is very important to check the care of the elderly. Family concern as a caregiver is needed in carrying out care for the elderly to ensure that the elderly are not neglected. AIM: The study aims to determine the effectiveness of the elderly caring model as an intervention to prevent the neglect of the elderly in the family. MATERIAL AND METHODS: The quasi-experimental design with the pre-control group non-equivalent test post-test was the provision of training in the elderly caring model by comparing 2 groups namely the intervention group using the module and control group without using the module. The sample is a family that has an elderly (age ≥ 60 years) who are the main caregivers of the elderly with a total of 50 people each for each group taken by multistage cluster sampling. Data collection through questionnaires to determine the variables of family older people about family support, family health assignments, social relations, and elderly social activities and preventive behavior of elderly neglect. Data analysis used the independent sample t-test and general linear model report measure (GLM-RM) test for repeated measurements. RESULTS: The results showed that there was an influence of the caring elderly model on increasing family support in the elderly, increasing family health duties on the elderly towards increasing social relations and social activities in the elderly and neglecting the neglect behaviour of the elderly in the family (p-value = 0,000). Improve the behaviour of preventing neglect of the elderly in the family compared to groups that do not use modules where the value of p = 0,000. CONCLUSION: It can be concluded that the elderly caring model effectively prevents my employees from neglecting the elderly in the family.

Differences in brain-derived neurotrophic factor between neonates born to mothers with normal and low ferritin.

BACKGROUND AND OBJECTIVES: Maternal iron deficiency in late pregnancy, labor, and the postpartum period has an indirect impact to decrease neurotrophin concentration in the fetal hippocampus, namely brain-derived neurotrophic factor (BDNF). It plays an important role in the development of learning, memory, and behavior. The aim of this study was to determine the differences in BDNF between neonates born to mothers with normal and low ferritin. METHODS AND STUDY DESIGN: This was an observational study with a cross-sectional design involving 20 term pregnant women with normal ferritin (>=12 ng/mL) and 20 term pregnant women with low ferritin (<12 ng/mL). Samples were taken from Yarsi hospital, BMC hospital, and Hardi clinic located in Padang, from August 2015 to February 2016. Umbilical cord plasma was examined directly after delivery using an enzymelinked immunosorbent assay (ELISA) employed at the Biomedical Laboratory of Andalas University. Mean differences were statistically assessed by independent samples t-test. RESULTS: Plasma BDNF concentrations in neonates born to mothers with normal and low ferritin were 3.81±1.37 ng/mL and 2.78±1.19 ng/mL, respectively (p=0.015). CONCLUSIONS: Plasma BDNF was lower in neonates born to mothers with low serum ferritin.

Analyses of Nutrients and Body Mass Index as Risk Factor for Preeclampsia.

Background: Little is known about the pathogenesis of preeclampsia. Many factors are identified as risk factors for preeclampsia including nutrients and obesity. The aim of this study was to assess whether nutrients and body mass index (BMI) are risk factors for preeclampsia. Methods: This was a case-control study at the Department of Obstetric and Gynecology in Dr. M. Djamil Hospital, Padang, Indonesia. A total of 140 patients were enrolled in this study with 70 cases and 70 controls. All subjects completed an interview for their nutritional status and prepregnancy BMI after delivery. The nutritional status was assessed by Food Frequency Questionnaire and then analyzed by Nutrisurvey Program. The independent samples t test was used for nutritional status, and Chi-square test was used for BMI. For nutrients, logistic regression procedures were employed to calculate potential risk factors associated with preeclampsia. Results: Prevalence of abnormal BMI was more common in the preeclampsia group compared with those without preeclampsia 19 (27.1%) versus 12 (17.1%) but not found as a significant risk factor in this study (p = 0.222). Deficiency of vitamin E (OR 1.76, 95% CI 10.2 ± 30.5), zinc (OR 99.4, 95% CI 1.37 ± 7219), fat (OR 59.1, 95% CI 3.14 ± 500), calcium (OR 109, 95% CI 0.29 ± 40,041), vitamin C (OR 19.5, 95% CI 2.52 ± 151) were associated with increased risk of preeclampsia. Excess of carbohydrate was associated with increased risk of preeclampsia (OR 52.9, 95% CI 0.801 ± 3495). Conclusions: Deficiency of vitamin E, zinc, fat, calcium, and vitamin C, and excess of calories and carbohydrate were associated with increased risk of preeclampsia.