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).

Hypnotherapy influence on maternal psychological, breastfeeding, mRNA-OXTR expression, and OXTR protein.

Hypnotherapy has emerged as a potential alternative to improve exclusive breastfeeding rates, particularly in countries like Indonesia where they are below optimal levels. This study aims to evaluate the impact of audio hypnotherapy on the psychological, exclusive breastfeeding behavior, the OXTR protein and mRNA expression gene OXTR in mothers of infants aged 0-6 months. This study employed a Pragmatic Randomized Controlled Trial design, conducted from November 2022 to May 2023 in 11 primary health centers. The study population included breastfeeding mothers with infants aged 0-6 months, with a total sample size of 70 respondents who were randomly divided into intervention (received audio hypnotherapy) and control groups (received standard care). The psychological condition was measured using the Depression Anxiety Stress Scale. Exclusive breastfeeding behavior was assessed based on both quality and quantity. Genetic factors were evaluated through mRNA OXTR expression using real-time PCR and protein OXTR levels using ELISA. Analyzing data using linear and logistic regression models. Both bivariate and multivariate analyses revealed significant differences in psychological condition (p < .0001). There were big differences in the exclusive breastfeeding behavior (p < .0001), as well as in the amounts of protein OXTR and mRNA expression of the OXTR gene (p < .0001). We recommend the implementation of audio hypnotherapy as an effective complementary therapeutic approach to manage the psychological well-being, exclusive breastfeeding behavior, the mRNA expression of the OXTR gene and levels of OXTR protein in mothers of infants aged 0-6 months.

Risk Factors and Nutritional Profiles Associated with Stunting in Children.

PURPOSE: To analyze risk factors and various nutrients associated with stunting among children aged 6-60 months. METHODS: This is a case-control and cross-sectional study between 40 stunting cases and 40 controls. Data on possible risk factors associated with stunting were obtained through direct interviews and using a questionnaire. Examination of vitamin D, zinc, albumin, and ferritin levels was performed on both groups. Data were analyzed using IBM SPSS Statistics for Windows, Version 23.0 (IBM Co., Armonk, NY, USA) to determine risk factors for stunting and to assess the relationship between nutritional levels and stunting. RESULTS: The incidence of stunting was highest in children aged 12-36 months. Children with low weight and very low weight for age comprised of 55% and 22.5%, respectively, of the study participants. The highest mother's educational level was junior high school (40%). History of low birth weight (LBW) was more commonly observed in the stunting group than that in the control group (25.0% and 7.5%, respectively; p=0.034, odds ratio, 0.310 [95% confidence interval, 0.122-0.789]). Approximately 7.5% of cases had premature birth. Exclusive breast feeding was found to be not correlated with stunting. The mean zinc level in the stunting group was 34.17 ng/mL, which was different from that in the control group (50.83 ng/mL) (p=0.023). Blood ferritin, vitamin D, albumin, and calcium levels were not strongly correlated with stunting. CONCLUSION: LBW is the main risk factor contributing to stunting and is strongly associated with low zinc level.