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.

Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial Study.

BACKGROUND: Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol was considered as having a role in reducing disease activity and improving quality of life. METHODS: A double blind, randomized, controlled trial was conducted on female  outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. RESULTS: Out of 60 subjects, 27 subjects in cholecalciferol group and 25 subjects in placebo group completed the intervention. There was a significant improvement on the level of vitamin D (ng/ml) after intervention in the cholecalciferol group, from an average of 15,69 ng/ml (8.1-28.2) to 49,90 ng/ml (26-72.1), and for the placebo group from 15,0 ng/ml (8.1-25,0) to 17.35 ng/ml (8.1-48.3) (p<0,000). Results of the MEX-SLEDAI score showed significant differences in both groups after the intervention, with a significant decrease in the cholecalciferol group from 2,67 (0-11) to 1,37 (0-6), compared to the placebo group from 2,6 (0-6) to  2,48 (0-6) (p<0,001). There were no significant differences on the quality of life in both groups. CONCLUSION: Supplementation of cholecalciferol 5000 IU/day for 12 weeks was statistically significant in increasing vitamin D levels and improving disease activity, but did not significantly improve the quality of life of SLE patients.

Ramadan fasting reduces high-sensitivity C-reactive protein among HIV-infected patients receiving antiretroviral therapy.

Background: Inflammatory conditions and oxidative stress increase in HIV infection, and inflammation increases the risk of cardiovascular disease. Ramadan fasting is known to reduce inflammation and oxidative stress in diabetic patients. This study examined the effects of Ramadan fasting on high-sensitivity C-reactive protein (hs-CRP) levels and total antioxidant status (TAOS) in HIV patients on antiretroviral therapy (ART). Methods: This was a prospective cohort study comparing HIV-infected patients on stable ART who fasted throughout Ramadan to HIV-infected patients who did not fast during Ramadan. Inclusion criteria were men aged 20-40 years, taking first-line ART for at least 6 months, Muslims intent to fast for Ramadan, no current hospitalization because of acute conditions and not being treated for opportunistic infections. Results: After 2 weeks, hs-CRP had decreased significantly in the fasting group (-0.41 mg/L [IQR = -1; 0.10]) compared to the non-fasting group (0.20 mg/L [IQR = -0.30; 1.50]) (p = 0.004). The linear regression analysis has shown that Ramadan fasting contributed to 10.10% of the variance in hs-CRP value (R 2 = 0.101) and decreased its value by 0.317 points (B = -0.317). Changes in TAOS did not significantly different (p = 0.405) between the fasting group (0.05 mmol/L [IQR = -0.03; 0.12]) and the non-fasting group (0.04 mmol/L [IQR = -0.13; 0.36]). In the fasting group, there were significant changes in polyunsaturated fatty acid consumption (p = 0.029), body weight (p = 0.001), cigarette smoking (p = 0.001), and sleeping duration (p = 0.001). Conclusion: Ramadan fasting reduces hs-CRP concentrations among HIV patients on ART.

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.