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).

Factors driving and inhibiting stunting reduction acceleration programs at district level: A qualitative study in West Sumatra.

Stunting prevalence varies significantly across Indonesian provinces and districts/municipalities, including West Sumatra. This research aims to identify the driving and inhibiting factors for implementing the stunting reduction acceleration program at the district level in West Sumatra. The research was conducted in 2022 with a qualitative study design and a case study approach. Data were collected through (i) group interviews with key informants involving policymakers and program managers at the provincial, district, sub-district, and village levels and (ii) in-depth interviews with mothers of stunted children. Two districts were selected as research sites. One district represents an area that has yet to be developed (District A or failed district). The other district has seen a significant reduction in the prevalence of stunting (District B or successful district). We found several driving and inhibiting factors that affect the reduced prevalence of stunting, such as the need for the relevant agency to play a strong role as the leading and responsible sector for stunting convergence actions. Another important factor is paying close attention to improving the quality of stunting data and providing adequate funding support. High commitment from Public Health Centers to maternal health through classes for pregnant women, infants, and children under the age of five can also have an impact. Furthermore, properly performing duties by assigned actors in specific and sensitive programs and integrated monitoring and evaluation of program implementation and outcomes can influence stunting prevalence. Recommendations for accelerating stunting reduction include improving communication and coordination, establishing stunting prevalence reduction as a performance indicator among the related district government and its various agencies, and assisting the village administration with planning and budgeting to support stunting prevention.