ABSTRACT
The development of a safe and effective vaccine is essential to protect populations against coronavirus disease 2019 (COVID-19). There are several vaccine candidates under investigation with different mechanisms of action. In the present study, we have evaluated the safety and immunogenicity of a recombinant receptor-binding domain (RBD)-based protein subunit vaccine (Noora vaccine) against COVID-19 in adults. This Phase 1 trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and immunogenicity of the recombinant RBD-based protein subunit vaccine (Noora vaccine) against COVID-19 in healthy adults volunteers. Eligible participants were included in this study after evaluating their health status and considering the exclusion criteria. They were then randomized into three groups and received three doses of vaccine (80 µg, 120 µg, and placebo) on Days 0, 21, and 35. Primary outcomes including solicited, unsolicited, and medically attended adverse events were recorded during this study. Secondary outcomes including the humoral and cellular immunity (including anti-RBD IgG antibody and neutralizing antibody) were measured on Days 0, 21, 28, 35, 42, and 49 by using the ELISA kit and the Virus Neutralization Test (VNT) was performed on day 49. Totally 70 cases were included in this Phase 1 trial and 60 of them completed the study. Safety assessments showed no severe adverse events. Local pain at the vaccine injection site occurred in 80% of the vaccinated volunteers. Induration and redness at the injection site were the other adverse reactions of this vaccine. There was no significant difference between the studied groups regarding adverse reactions. Anti-RBD IgG antibody and neutralizing antibody assessment showed significant seroconversion in comparison to the placebo group (80%, and 100% respectively, p < 0.001). The cellular immunity panel also showed mild to moderate induction of TH1 responses and the VNT showed 78% of seroprotection. The results of this Phase 1 trial showed acceptable safety without serious adverse events and significant seroconversions in the humoral and cellular immunity panel. The dose of 80 µg is an appropriate dose for injection in the next phases of the trial.
ABSTRACT
Background and Objectives: The severity and mortality of coronavirus disease 19 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 are positively associated with underlying diseases such as hypertension, diabetes, and chronic kidney disease (CKD). In this regard, the current study aimed to evaluate the clinical characteristics, laboratory findings, and outcomes of coronavirus disease 2019 (COVID-19) hospitalized patients with and without CKD. Methods: This cross-sectional matched study was conducted on hospitalized confirmed COVID-19 patients with and without CKD admitted to Baqiyatallah Hospital in Tehran, Iran, from February 26, 2020 to March 26, 2020. The patients were homogenized in terms of age, gender, body mass index, and underlying diseases such as hypertension and diabetes. Demographic data, clinical symptoms, and laboratory and radiological findings were collected from patients' medical records and compared between the patients based on their CKD status. Results: Among the COVID-19 patients, 56 and 97 cases with and without CKD were investigated, respectively. In general, 111 (72.5%) patients with a mean age of 55 years were males. Patients with CKD had higher levels of blood urea nitrogen, creatinine, and red cell distribution width (p<0.05). No differences were found regarding chest computed tomography findings, ICU admission, and death among COVID-19 patients with and without CKD. Conclusions: Overall, the findings support the use of red cell distribution width, blood urea nitrogen, and creatinine for monitoring the COVID-19 patients with CKD and assessing the risk of disease progression. Eventually, managing comorbidities including hypertension and diabetes will reduce COVID-19 severity in CKD patients. [ FROM AUTHOR] Copyright of Electronic Journal of General Medicine is the property of Modestum Publications and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)