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.

Consensus Guidelines for Influenza Vaccination in Patients with Diabetes.

Influenza is a prevalent health issue encountered in daily practice. Patients with diabetes mellitus face a higher risk of infections, including influenza, owing to the compromised immune system associated with diabetes. This susceptibility arises from the potential of diabetes mellitus to weaken the immune system. Moreover, elevated blood glucose levels can create a conducive environment for the growth of bacteria and viruses. This consensus is formulated by a multidisciplinary team to serve as practical guidance for the administration of influenza vaccinations to patients with diabetes mellitus in daily practice.

Efficacy, Immunogenicity, and Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases: A Systematic Review and Meta-Analysis.

Patients with autoimmune diseases are among the susceptible groups to COVID-19 infection because of the complexity of their conditions and the side effects of the immunosuppressive drugs used to treat them. They might show impaired immunogenicity to COVID-19 vaccines and have a higher risk of developing COVID-19. Using a systematic review and meta-analysis, this research sought to summarize the evidence on COVID-19 vaccine efficacy, immunogenicity, and safety in patients with autoimmune diseases following predefined eligibility criteria. Research articles were obtained from an initial search up to 26 September 2022 from PubMed, Embase, EBSCOhost, ProQuest, MedRxiv, bioRxiv, SSRN, EuroPMC, and the Cochrane Center of Randomized Controlled Trials (CCRCT). Of 76 eligible studies obtained, 29, 54, and 38 studies were included in systematic reviews of efficacy, immunogenicity, and safety, respectively, and 6, 18, and 4 studies were included in meta-analyses for efficacy, immunogenicity, and safety, respectively. From the meta-analyses, patients with autoimmune diseases showed more frequent breakthrough COVID-19 infections and lower total antibody (TAb) titers, IgG seroconversion, and neutralizing antibodies after inactivated COVID-19 vaccination compared with healthy controls. They also had more local and systemic adverse events after the first dose of inactivated vaccination compared with healthy controls. After COVID-19 mRNA vaccination, patients with autoimmune diseases had lower TAb titers and IgG seroconversion compared with healthy controls.

A Case Report of Hereditary Angioedema: Challenges in Diagnosis and Management.

Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder which causes bradykinin mediated angioedema. Although it can be life threatening, HAE may be underdiagnosed due to a lack of awareness of the disease and limited access to laboratory testing. Here, we report a case of HAE which was diagnosed only after the patient was referred for COVID-19 vaccination even though he had been experiencing recurrent angioedema for the past 30 years.

Factors Related to Severity, Hospitalization, and Mortality of COVID-19 Infection among Patients with Autoimmune Diseases.

Patients with an autoimmune disease could be at higher risk of a poor outcome when contracting COVID-19 infection due to aberrant immune responses and use of immunosuppressant therapies for chronic autoimmune treatment. Here, we conducted a retrospective study to identify the factors related to severity, hospitalization, and mortality among patients with autoimmune diseases. We found 165 cases of patients with pre-existing autoimmune diseases who had contracted COVID-19 between March 2020 and September 2022. Data on demographical characteristics; autoimmune diagnosis and treatment; COVID-19 vaccination status; and time, severity, and outcome of COVID-19 infection were collected. Most of the subjects were female (93.3%) and autoimmune diagnoses included systemic lupus erythematosus (54.5%), Sjogren's syndrome (33.5%), antiphospholipid syndrome (23%), vasculitis (5.5%), autoimmune thyroid disease (3.6%), rheumatoid arthritis (3.03%), and inflammatory bowel disease (3.03%) among other autoimmune diseases. There were four COVID-19-related deaths in this study. Factors associated with moderate to severe COVID-19 infection in patients with autoimmune diseases included not being vaccinated against COVID-19, taking a steroid of ≥10 mg prednisone-equivalent per day, and having a cardiovascular disease. Taking a steroid of ≥10 mg prednisone-equivalent per day was also associated with hospitalization in the event of COVID-19 infection, while cardiovascular diseases also showed a significant correlation to mortality in patients with autoimmune diseases who had been hospitalized with COVID-19 infection.

COVID-19 Vaccination Intention in Patients with Autoimmune Diseases in Indonesia: An Application of the Integrated Behavioural Model.

Vaccine hesitancy can be a challenge for those with autoimmune diseases. This study investigated the acceptance of COVID-19 vaccination by patients with autoimmune diseases in Indonesia using the integrated behavioral model (IBM). This cross-sectional study was conducted from December 2021 to February 2022. A total of 404 patients with autoimmune diseases completed the survey. The majority of respondents (57.9%) said they intended to get vaccinated against COVID-19. The IBM model with added demographic variables explained 54.1% of the variance of vaccination intention (R2 = 0.541). Self-efficacy, perceived norms, experiential attitude, and instrumental attitude are significantly correlated with vaccination intention in components of health behavior theories. Self-efficacy is the most critical factor influencing vaccination intention in patients with autoimmune diseases (F(2, 401) = 96.9, p < 0.001, R2 = 0.326). In the multivariate analysis, vaccine intention was found to be positively associated with patients' occupation as health-care workers (ß = 0.105). Meanwhile, having a personal history of contracting COVID-19 and having co-morbidities other than autoimmune diseases were negatively correlated to the willingness to be vaccinated against COVID-19. This study confirms the viability of the IBM model for predicting the COVID-19 vaccination intention of patients with autoimmune diseases. It is essential to provide patients with autoimmune diseases with information that is clear and supported by evidence-based medicine.

COVID-19 vaccine provocation test outcome in high-risk allergic patients: A retrospective study from a tertiary hospital in Indonesia.

Background: High COVID-19 vaccine coverage is essential. Patients who are considered high risk for hypersensitivity reactions and have had an allergic reaction to the COVID-19 vaccine are usually referred to an allergist for assessment of vaccination. Administration of a vaccine graded challenge (also known as a provocation test) is an option that can be considered in this population. This primary objective of this study is to describe the outcome of the COVID-19 vaccine provocation test and to understand the predicting factors associated with hypersensitivity reaction after the provocation test as the secondary objective. Methods: Adult patients with a history of hypersensitivity reaction to the first COVID-19 vaccine and high-allergic patients who underwent COVID-19 vaccine provocation test up until May 2022 were included. A protocol using skin prick test (SPT), intradermal test (IDT), followed by graded challenge was developed for the determined vaccine used. Results: A total of 232 patients were included in the analysis. Twenty-eight had hypersensitivity to their first COVID-19 vaccine dose and 204 were high risk for allergic reaction. Hypersensitivity reactions occurred in 20 patients (8.6%, 95% CI: 5-12.2%), consisting of 4 reactions after SPT, 9 after IDT, 7 during or after titrated challenge. Half of the reactions were mild; however, 3 patients developed severe reactions. Patients with history of anaphylaxis were more likely to experience hypersensitivity reaction after provocation test (aRR = 2.79, 95% CI: 1.05-7.42). Conclusion: Provocation test in COVID-19 vaccination has a high success rate in patients with a history of hypersensitivity to the first COVID-19 vaccine and in high allergic patients. History of anaphylaxis is associated with hypersensitivity reaction after a COVID-19 vaccine provocation test.

COVID-19 Booster Vaccine Intention by Health Care Workers in Jakarta, Indonesia: Using the Extended Model of Health Behavior Theories.

In Indonesia, COVID-19 vaccination hesitancy persists among health care workers (HCWs). Understanding the motives and challenges impacting HCWs' acceptance of the booster vaccination is critical. Efforts are still needed to overcome apprehension about taking a booster dosage. This study aims to analyze the vaccine acceptance among HCWs in Jakarta using an extended, modified model of health behavior theories, namely The Health Belief Model (HBM) and The Theory of Planned Behavior (TPB). A cross-sectional survey from November 2021 to January 2022 was distributed to health care workers in Jakarta. Bivariate analysis followed by multivariate regression was used to assess factors associated with the vaccine intention and collected 1684 responses. The results have shown that the final model combining the constructs and demographic characteristics could explain 50% of the variance of intention to receive a COVID-19 booster vaccination. Moreover, anticipated regret had the most significant standardized coefficient among the constructs (ß = 0.381, p < 0.001). Other significant predictors in the model were attitude (ß = 0.243, p < 0.001), perceived benefits (ß = 0.103, p < 0.001), subjective norms (ß = 0.08, p = 0.005), and perceived susceptibility (ß = 0.051, p = 0.016). The findings can be used to strategize interventions to increase vaccine uptake.

Using Integrative Behavior Model to Predict COVID-19 Vaccination Intention among Health Care Workers in Indonesia: A Nationwide Survey.

Background: Health care workers (HCWs) are a high-priority group for COVID-19 vaccination for several reasons. Health behavior theory-based studies on the intention or acceptability of COVID-19 vaccination among Indonesian HCWs is lacking. Using an integrated behavioral model, this research sought to identify Indonesian health care workers' intentions to obtain COVID-19 vaccines. Methods: A countrywide cross-sectional questionnaire-based survey was conducted. The questionnaire was constructed on the basis of IBM (integrated behavioral model) constructs and scored on a seven-point bipolar scale. A hierarchical multivariable regression was used to evaluate the fit of the predictor model as well as the correlations between variables in the study. Results: 3304 people responded to the survey. A model combining demographic and IBM characteristics predicted 42.5 percent (adjusted R2 = 0.42) of the COVID-19 vaccination intention. Vaccination intention was associated with favorable vaccine attitudes, perceived norms, and self-efficacy. Among the determining constructs, behavior belief predicted vaccination intention the best. Being female, being married, having a history of COVID-19 infection, living outside Java Island, and having a low income were all linked to lower vaccination intentions. Conclusions: This study confirms the IBM model's robustness in predicting health care workers' intention to vaccinate against COVID-19.

Knowledge, Attitude, Behavior, and Socioeconomic Conditions of People Living with HIV in Indonesia During the COVID-19 Pandemic: A Cross-Sectional Study.

PURPOSE: This study aimed to analyze the knowledge, attitude, and behavior of people living with HIV (PLWH) during the COVID-19 pandemic and the pandemic's impact on their socioeconomic conditions, antiretroviral adherence, and worries. MATERIALS AND METHODS: This cross-sectional study was conducted in May-August 2020 at the Integrated HIV Center of Dr. Cipto Mangunkusumo General Hospital, Indonesia. The data were collected using an online questionnaire and an offline paper-based questionnaire. RESULTS: A total of 545 subjects participated in this study, 72.8% (397) of which were male. Most subjects were middle-aged (36-55 years old) (66.5%). Many subjects reported to have experienced reduced incomes (49.2%) or losses of income (22.4%), while 15.6% reported losing their job during the COVID-19 pandemic. Most subjects (97%) wished to continue treatment despite the many obstacles, and the subjects' knowledge about COVID-19 and its prevention was considerably good. More than 70% of subjects reported that they have been implementing the general precautions of the COVID-19 pandemic: maintaining distance, wearing a mask, washing hands, and avoiding crowds. CONCLUSION: This study provides an overview of what PLWH are experiencing, which will allow for policy-making that can help them continue their treatment with consideration of the possibility of having to live a "new normal" future.

COVID-19 Vaccines: Current Status and Implication for Use in Indonesia.

The coronavirus disease 2019 (COVID-19) has inflicted catastrophic damages in public health, economic and social stability-putting life globally on hold in 2020 and presumably a year more. Indonesia bears a heavy burden of the pandemic, counting the highest case prevalence and fatality rate in all of Southeast Asia. One hope remains in the groundbreaking universal effort in search of a vaccine against the causative virus SARS-CoV-2, which has shown success unparalleled in human vaccine development thus far. An array of modalities including novel techniques are being utilized as vaccine platforms, with the closest to phase III clinical trial completion being mRNA (manufactured by Moderna and BioNTech/Pfizer), inactivated virus (Sinovac, Sinopharm), viral vector (Oxford/AstraZeneca, Gamaleya, Janssen/Johnson&Johnson, CanSino), and protein subunit (Novavax). The vaccine produced by BioNTech/Pfizer has been deployed to the public as the first ever licensed COVID-19 vaccine. In this review, we will review all of these modalities on their safety and immunogenicity, phase II/III trial results of the nine vaccine candidates and current situation as of 29 December 2020, as well as the implication for use and distribution in Indonesia. COVID-19 vaccine progress, however, is moving exceedingly fast and new advances are unfolding on a daily basis, to which we hope an update to this review can be published in early 2021.

Factors Related to Knowledge, Perception, and Practices Towards COVID-19 Among Patients with Autoimmune Diseases: A Multicenter Online Survey.

BACKGROUND: autoimmune patients can be more susceptible to infection. Proper knowledge, perception, and practices towards COVID-19 are essential for these patients during pandemic. This study aimed to know their knowledge, perception, and practices regarding COVID-19. METHODS: cross sectional study using online survey was conducted from April to May 2020. Patients with autoimmune disease were asked about demographic characteristics, diagnosis, history of treatment, knowledge, perception, and practice regarding COVID-19. RESULTS: there were 685 respondents. Most of them were female and had systemic lupus erythematosus with median age of 37 years old. Almost all respondents had good knowledge regarding transmission of COVID-19 and did proper prevention practices. Adequacy of information and steroid or mycophenolate mofetil/mycophenolic acid (MMF/MPA) use were related to perception of the effect of pandemic to their own health. Visiting private clinic and receiving hydroxychloroquine/chloroquine sulfate or sulfasalazine were related to perception that autoimmune conditions would make them more prone to COVID-19. Work from home was related to perception that when contracting COVID-19, the symptoms would be more severe. Living in Sumatra region and getting hydroxychloroquine/chloroquine sulfate or MMF/MPA were related to perception that autoimmune medications could reduce risk of getting COVID-19. Adequate information, university education, private clinic visit, and hydroxychloroquine/chloroquine sulfate use were related to perception that COVID-19 pandemic would cause difficulties in getting medications. CONCLUSION: almost all respondents had good knowledge and practices regarding COVID-19. Adequacy of information, autoimmune treatment, work from home, educational background, area of living, and health care facilities contributed to perception regarding COVID-19 pandemic.

Factors Affecting Virological Outcome When First-Line Antiretroviral Therapy Is Reintroduced After Unplanned Interruption.

There is no guideline concerning choice of antiretroviral therapy (ART) for HIV-infected patients after unplanned interruption. We conducted a retrospective cohort study of HIV-infected patients reintroduced to first-line ART after having unplanned interruption for at least 1 month. Viral load was evaluated at 6 to 18 months after the reintroduction. There were 100 patients included in our study, and 55 of them achieved virological success. History of single interruption (adjusted odds ratio [aOR] 5.51%, 95% confidence interval [CI] 1.82-16.68, P = .003) and CD4 count ≥200 cell/mm3 at the time of reintroduction (aOR 4.33, 95% CI 1.14-16.39, P = .031) increased likelihood to achieve virological success.