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. 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. 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. IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax. (ClinicalTrials.gov: NCT05433285, Indonesian Clinical Research Registry: INA-R5752S9).

Our understanding of the influence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on bacterial colonization in the children’s upper nasopharyngeal tract during the coronavirus infectious disease (COVID-19) pandemic is limited. This study aimed to determine whether there were any differences in bacterial colonization between asymptomatic children with or without a positive SARS-CoV-2 quantitative reverse transcriptase-polymerase chain reaction (RT-qPCR) results in the community setting. A cross-sectional community-based exploratory study was conducted from March to May 2021 in Semarang, Central Java Province, Indonesia. Using stored nasopharyngeal swabs collected from children under 18 years as a contact tracing program, we performed a real-time quantitative (qPCR) for the most important bacterial colonizing pathogens: Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and Klebsiella pneumoniae. Swabs from a total of 440 children were included in this study, of which 228 (51.8%) were RT-qPCR-confirmed SARS-CoV-2 positive. In the 440 children, colonization rates were highest for H. influenzae (61.4%), followed by S. pneumoniae (17.5%), S. aureus (12.0%), and K. pneumoniae (1.8%). The co-occurrence of both S. pneumoniae and H. influenzae in the upper respiratory tract was significantly associated with a SARS-CoV-2 negative RT-qPCR. In contrast, colonization with only S. aureus was more common in SARS-CoV-2-positive children. Overall, this exploratory study concludes that there is a significant difference in the bacterial nasopharyngeal colonization pattern between SARS-CoV-2 positive and negative in asymptomatic children in the community in Indonesia.

Purpose: Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine. Materials and Methods: An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject's safety was monitored for 28 days after each vaccination. Results: Of 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines. Conclusion: Investigational vaccines are shown to be equally immunogenic and safe as the control vaccine.

As the coronavirus disease 2019 (COVID-19) pandemic spread across Indonesia, good knowledge, proper attitude, and appropriate practices among undergraduate students must be achieved before starting a face-to-face lecture. These are also important since most students are active in social media and can spread true or false rumors regarding COVID-19. This study aimed to assess the level of knowledge, attitudes, and practices of medical and non-medical undergraduate students toward COVID-19. A 51-item online questionnaire was developed and sent to random undergraduate students from different faculties in Universitas Diponegoro, Indonesia. A total of 482 students completed the survey. The Chi-square test showed significant associations in the level of knowledge, attitudes, and practices towards the COVID-19 between medical and non-medical students, where medical students have better knowledge, attitudes, and practices than non-medical students. This study's findings may become the basis for an awareness campaign planning among students in particular and the public in general, which at this time most student activities are still carried out online and to prepare face-to-face lectures and also to deepen the material regarding COVID-19 among students, especially non-medical students, and furthermore, help to guide the efforts and plans of state health authorities for better containment of COVID-19.

Background: The global COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), experienced a surge in cases with the emergence of the Omicron variant. Despite increasing vaccination coverage, Indonesia witnessed peaks in COVID-19 cases. Variant screening and whole genome sequencing (WGS) play a crucial role in identifying SARS-CoV-2 variants and monitoring their spread.Objective: The objective of this study was to compare variant screening results with WGS data, assess the prevalence of subvariants, and analyze their correlation with demographic and cycle threshold (CT) values.Methods: Between November 7th and 18th, 2022, variant screening and WGS were conducted on samples with CT values below 30. Variant screening utilized the mBioCov-19+ VarScreen assay, while WGS was performed on the Oxford Nanopore Technologies (ONT) platform. Bioinformatics analysis was performed using epi2melabs. Demographic data and CT values were analyzed. Results: Out of 89 subjects, all tested positive for the Omicron variant through variant screening. The variant screening identified two subvariants: Omicron BA.2 (64%) and Omicron B.1.1.529.1 (36%). WGS revealed that the XBB subvariant was the most dominant (52.8%), followed by BQ.1 (22.5%) and BA.5 (13.5%). When VarScreen indicated BA.2, the majority of WGS results showed XBB (82.5%), while for B.1.1.529.1, the majority of WGS results were BQ.1 (59.4%), followed by BA.5 (37.5%). XBB was the most prevalent variant in both females and males, while BQ.1 was more dominant in females (80%). No infections were detected among children aged 1-5 years. All variants had CT values below 24.Conclusion: Variant screening provides accurate and quick results for detecting the Omicron variant in laboratories without WGS capacity. However, it is important to continuously update the screening methodology based on the prevailing circulating variants. During the study period, XBB emerged as the predominant subvariant of the Omicron variant.

Introduction: We conducted a Phase I SARS-CoV-2 vaccine trial in March 2022. During the screening, we identified a significant number of asymptomatic COVID-19 cases among the candidate participants. We aimed to highlight the clinical characteristics among these asymptomatic individuals as compared to subjects negative for SARS-CoV-2. Methods: This observational study was conducted during participant screening for a Phase I SARS-CoV-2 vaccine trial in Jepara and Mranggen districts in Central Java, Semarang, Indonesia. Participants who reported no symptoms associated with COVID-19, confirmed by physical examinations, were included. Data on laboratory markers were documented. An asymptomatic case was defined as showing no clinical symptoms and signs of SARS-CoV-2 infection with a positive SARS-CoV-2 RT-PCR result. Individuals who tested negative for SARS-CoV-2 were included for comparison. A chi-square test was employed to assess the differences between the two groups, with a p-value 0.05) among individuals with positive and negative SARS-CoV-2. Conclusion: In our vaccine trial screening phase, almost half were ineligible due to having asymptomatic SARS-CoV-2 infections. In addition, it is necessary that people with asymptomatic COVID-19 infection still need to be concerned because they have the same transmission potential.