Impact of SARS-CoV-2 AstraZeneca Vaccine on Safety and Blood Elements of Egyptian Healthcare Workers.

Background: Many coronavirus disease 2019 (COVID-19) vaccines were approved worldwide. Their safety was the primary concern. In Egypt, Oxford-AstraZeneca (AZ) vaccine was the first approved vaccine initially for healthcare workers (HCWs). Objective: We aim to determine adverse events and hematological abnormalities following the COVID-19 AZ vaccine and estimate the infection rate of the candidates by COVID-19 between the first and second doses of vaccination. Methods: Within 8-10 days of receiving their initial dose of the AZ vaccine, 909 HCWs were assessed for adverse events as part of a prospective longitudinal study. Complete blood counts (CBCs) were evaluated before and one month after vaccination. Results: 37.2% of the candidates experienced side effects following vaccination. Pain at the injection site was the most common (25.4%) and more frequent in participants between 20 and 40 years (27.9%). The mean total leukocyte count (TLC), absolute leukocyte count (ALC), absolute neutrophil count (ANC), and absolute monocyte count (AMC) increased one month following vaccination (P < 0. 001). Sixty-six vaccinated HCWs were infected with COVID-19 between the two vaccine doses. 82% were infected after 14 days of the first dose, while 18% were infected before 14 days (P < 0.0001). Conclusions: Most of the vaccinated personnel did not experience any side effects after the first dose of the vaccine. Furthermore, the most common complaints were pain at the injection site, fatigue, fever, headache, arthralgia, myalgia, and chills. Infected people with COVID-19 after the first dose had significantly more severe disease if they were infected before 14 days than those who got infected later on.

Effect of obligatory Hepatitis B vaccination program on the prevalence of occult hepatitis B among pregnant women in Egypt: A cross sectional study.

Hepatitis B virus (HBV) infection is a global health problem. HBV is of intermediate endemicity in Egypt. "Occult" HBV (OBI) indicates replication of HBV-DNA in the liver of individuals with negative serum HBsAg. This study aimed to determine the prevalence of OBI among pregnant women in Egypt and to compare this prevalence among HBV vaccinated and unvaccinated women (received obligatory vaccination). This cross-section study included 474 pregnant women in the third trimester divided in two groups. Group I: (n=247) assumed received obligatory hepatitis B vaccination and group II: (n=227), did not receive HBV vaccination. Study participants were screened for HBsAg, anti HBs, anti HBc total, anti HBc IgM, HBeAg, anti HBe, HCV Ab, and HIV Ab by immunoassays and HBV-DNA by Real-Time PCR. Anti HBs was detected in 65 (13.7%) of pregnant women, 36 (14.6%) in the vaccinated group and 29 (12.8%) in the unvaccinated group. The anti HBs levels were significantly higher in the unvaccinated group. HBc Ab showed positive results in 6 cases (2.4%) in the vaccinated group, and 14 cases (6.2%) in unvaccinated group. HBcAb and/or HBsAb were detected in 72 (15.1%) of pregnant women, 39 (15.8%) in the vaccinated group and 33 (14.5%) in the unvaccinated group. HBV-DNA was detected only in one vaccinated pregnant woman. HB vaccination program in Egypt, since 1992 affected the frequency of OBI in pregnant women (p=0.04). In conclusion, HBV infection may persist lifelong in the hepatocytes even when viral functions are suppressed, HBsAb and anti-HBc-positive individuals are present. The levels of HBsAb were higher in unvaccinated pregnant women compared to vaccinated pregnant women. HBV infection in OBI pregnant women may not transmit to the new-born.

Low baseline vitamin D levels increase the risk of bone metastases among females with breast cancer - Hospital based cohort study.

BACKGROUND: Serum vitamin D (Vit-D) has been linked to the development of breast cancer (BC); however, their effect on pathological features and outcomes is undetermined. The purpose of this study was to examine the prognostic significance of baseline Vit-D levels and their effect on clinical outcomes. METHODS: We evaluated baseline serum Vit-D levels and baseline clinic-pathological features of female patients with non-metastatic BC between October 2018 and December 2019. A low Vit-D level was described as less than 30 nanogram per liter (ng/l). Patients were observed for a median of 24 months. To evaluate relationships between qualitative variables, the chi-square test was used. The Kaplan-Meier technique was used for survival analysis, and the log-rank test was used to compare the two survival curves. Correlation analysis was also used to examine the link between Vit-D levels and clinical outcomes. RESULTS: The eligibility criteria were fulfilled by 221 patients. The median age of onset was (50.7). The median Vit-D level was (23.1 ng/l) with a range of (4-46 ng/l). Approximately half of the patients (56.5%) had Vit-D levels < 30 ng/l, with HER2 positive and triple negative (TNBC) patients having a greater proportion of low Vit-D levels (p = <0.001). Patients with low baseline Vit-D levels had a larger tumor size, more positive lymph nodes, and were diagnosed at a later stage. Following follow-up, Vit-D deficiency was associated with a significantly increased risk of bone metastases (HR 3.37, 95% CI 1.32-8.59, p = 0.006), and Vit-D levels were significantly correlated with disease-free survival (DFS) and overall survival (OS) (r = 0.850, r = 0.573, p < 0.00, p < 0.001, respectively). CONCLUSIONS: Low serum Vit-D is associated with advanced stage and adverse characteristics. It is more prevalent in HER-2 positive and TNBC patients; it increases the chance of bone metastases, and has a significant correlation with DFS and OS.

Evaluation of the accuracy of multiplex polymerase chain reaction in differentiation between bacterial and viral meningitis.

BACKGROUND: Meningitis is one of the most dangerous infection affecting children. The need for rapid and accurate diagnosis is mandatory for improving the outcome. AIM OF THE WORK: To evaluate the role of multiplex polymerase chain reaction (PCR) in diagnosis of meningitis either bacterial or viral and to detect its accuracy. PATIENTS AND METHODS: A cross-sectional study was carried out in University Children Hospital, Faculty of Medicine, between November 2019 and September 2020. The study was approved by the Ethics Review Board of Faculty of Medicine, Assiut University, and informed written consent was obtained. The committee's reference number is 17200161. Clinicaltrails.gov ID: NCT03387969. Forty-eight children aged 2 to 18 years with meningitis were included. Detailed history and examination, blood glucose level at time of admission prior to lumbar puncture, and multiplex PCR in cerebrospinal fluid (CSF) were evaluated. RESULTS: The mean age of children was 3.27 ± 1.27 years. Thirty-five (72.9%) cases were bacterial meningitis while 13 (27.1%) cases were viral meningitis. Multiplex PCR had 94% sensitivity and 100% specificity for diagnosis of bacterial meningitis. CONCLUSION: Multiplex PCR may help in diagnosis and differentiation of bacterial and viral meningitis with accurate and rapid results.

Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.

BACKGROUND AND STUDY AIMS: Currently, there is no therapy approved for COVID-19. We evaluated the efficacy and safety of sofosbuvir/ledipasvir and nitazoxanide for the treatment of patients with COVID-19 infection. PATIENTS AND METHODS: A multicenter, open-label randomized controlled trial included one hundred and ninety patients with non-severe COVID-19 infection. Patients were randomized into three groups. All groups received standard care treatment (SCT). In addition, group 1 received sofosbuvir/ledipasvir, and group 2 received nitazoxanide. Follow-up by reverse-transcriptase polymerase chain reaction (RT-PCR) was done at intervals of 5, 8, 11, and 14 days. The primary endpoint was viral clearance. RESULTS: Viral clearance was significantly higher in the sofosbuvir/ledipasvir and nitazoxanide groups compared to the SCT group in all follow-up intervals (p < 0.001). In the sofosbuvir/ledipasvir arm, 36.9% showed early viral clearance by day 5. By day 14, 83.1% of the sofosbuvir/ledipasvir group, 39.7% of the nitazoxanide group, and 19.4% of the SCT group tested negative for SARS-CoV-2. Sofosbuvir/ledipasvir and nitazoxanide treatment were the only significant factors in Cox regression of negative RT-PCR with the highest OR (17.88, 95% CI: 6.66-47.98 and 2.59, 95% CI: 1.11-6.07, respectively). No mortality or serious adverse events were recorded. CONCLUSION: The addition of sofosbuvir/ledipasvir or nitazoxanide to the SCT results in an early and high viral clearance rate in mild and moderate patients with COVID-19. These drugs represent a safe and affordable treatment for COVID-19.

Pooled-Testing for SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR) in asymptomatic healthcare workers in EL-Raghy isolation COVID-19 hospital, Assiut University.

COVID-19 pandemic is a substantial challenge for healthcare systems. Severe acute respiratory syndrome coronavirus (SARS-CoV-2) reverse transcription-polymerase chain reaction (RT-PCR) tests are considered the gold standard technique for diagnosis of symptomatic and asymptomatic infectious viral carriers and for screening special or at-risk populations. The pooled testing procedure is commonly used to reduce the cost of screening a large number of individuals for infectious diseases. This work was conducted to verify the accuracy of the standard SARS COV-2 RT- real-time PCR kit for detecting a single positive sample in a pool of negative samples. Kit verification using negative and positive samples was performed for the selection of the target pool sizes. RNA extracts from 443 healthcare workers, after 15 days' rotation in EL-Raghy Isolation COVID-19 Hospital, Assiut University during the first outbreak of COVID-19 pandemic (the period from June to September 2020) were obtained and tested. Sixty-three different pool sizes (2, 3, 4, 5, 6, 7, 8, 9, and 10) were tested for the presence of SARS-CoV-2 using RT-qPCR. Of these, 53 pools (84.1%) were negatives and 10 pools (15.9 %) tested positive. The individual number of SARS- COV 2 RT-PCR tests used in different pool sizes was 40 tests. The total number of SARS- COV 2 RT-PCR test used in this study was 110 tests instead of 443 tests which reflect a decrease in cost up to 75.16%. In conclusion, the suggested pooling strategy can reduce testing loads which enable substantial savings in reagent costs, technical burden, and time to generate laboratory results.

Accuracy of Cerebrospinal Fluid C-Reactive Protein and Multiplex Polymerase Chain Reaction and Serum Procalcitonin in Diagnosis of Bacterial and Viral Meningitis in Children.

BACKGROUND: Meningitis is one of the most dangerous infection affecting children. The need for rapid and accurate diagnosis is mandatory for improving the outcome. AIM OF THE WORK: to evaluate the role of multiplex polymerase chain reaction (PCR), cerebrospinal fluid (CSF)-C-reactive protein (CRP) and serum procalcitonin (PCT) in diagnosis of meningitis and to detect its accuracy. PATIENTS AND METHODS: A cross-sectional study was carried out in University Children hospital, Faculty of Medicine, between November 2019 and September 2020. The study was approved by the Ethics Review Board of Faculty of Medicine, Assiut University, and informed written consent was obtained. The committee's reference number is 17200161. CLINICALTRIALS: gov ID: NCT03387969. 48 Children aged 2 to 18 years with meningitis were included. Detailed history and examination. Blood glucose level at time of admission prior to lumbar puncture, serum CRP level, serum PCT, CSF-CRP level and Multiplex PCR were evaluated. FUNDING: The study was supported by Grant Office of Faculty of Medicine, Assiut University with grant NO. 2018-01-04-006-R2. RESULTS: The mean age of children was 3.27 plus or minus 1.27 years. 35 (72.9%) cases were bacterial meningitis, while 13 (27.1%) cases were viral meningitis. Patients with bacterial meningitis had significantly higher serum CRP, serum PCT and higher CSF-CRP and significantly lower CSF/blood glucose compared to viral meningitis. Multiplex PCR had 94% sensitivity and 100% specificity for diagnosis of bacterial and viral meningitis. CONCLUSION: CSF-CRP, CSF/blood glucose, PCT and Multiplex-PCR may help in diagnosis and differentiation of bacterial and viral meningitis.

Chlamydia trachomatis Infection: its relation to semen parameters and sperm DNA integrity.

The present study was conducted to determine the effect of Chlamydia trachomatis (CT) infection on semen quality and sperm DNA integrity. The study included 60 infertile male patients with CT infection and 25 age matched controls. Diagnosis of patients was based on detection of CT IgA by ELISA in seminal plasma and CT plasmid DNA in the semen sediment. All patients and controls were subjected to the following investigations: history taking, conventional semen analysis, detection of CT IgA, Plasmid DNA in semen samples, reactive oxygen species (ROS) and percentage of DNA fragmentation. There was significant increase in semen ROS levels and the percentage of sperm DNA fragmentation in the CT patient group when compared to the control group (P<0.05) and in those with leukocytospermia when compared to those without leukocytospermia (P<0.05). In the patient group with CT infection there was a positive correlation between the percentage of DNA fragmentation, ROS (r = 0.82 with P<0.0001) and pus cell count. (r = 0.7 with P<0.0001). In patients with leukocytospermia, there was a positive correlation between the percentage of DNA fragmentation, ROS (r = 0.9 with P<0.0001) and pus cell count (r = 0.83 with P<0.0001). In conclusion, sperm concentration, mobility, and viability, are significantly decreased in patients with CT compared to controls. ROS levels and the percentage of sperm DNA fragmentation significantly increased in CT patients especially patients with leukocytospermia.

Toll Like Receptor 3 Polymorphisms in Hepatitis B Virus Infection.

Hepatitis B virus (HBV) is the one of the major causes of chronic liver disease. Individuals exposed to HBV show wide spectrum outcomes including immunized persons, asymptomatic carrier, chronic active hepatitis, cirrhosis and HCC. The outcome of HBV infection and the severity of associated liver diseases are determined by the nature and strength of host immune responses against the virus. There is accumulating evidence that the innate branch of the host immune system plays an important role in the control of HBV infection. Various components including toll-like receptor (TLR) contribute to this nonspecific innate immune response .TLR3 play an important role in innate immune response against viral pathogens. Single nucleotide polymorphisms (SNPs) in the TLR3 could be considered as factors for the susceptibility to viral pathogens including HBV. This study aimed to investigate the distribution of six SNPs of the TLR3 gene in patients infected with HBV and to determine the relation between these SNPs and the clearance of hepatitis B virus. These SNPs were tested by direct sequencing. Three groups were investigated: chronic HBV carrier (25 patients), chronic active HBV carrier (16 patients) and 13 persons who were previously exposed to HBV and became immunized. These 3 groups were examined for six SNPs (rs5743311, rs5743312, rs5743313, rs5743314, rs5743315, and rs78726532). The analysis showed high frequencies of GCTCCA haplotype and CCA haplotype in the immunized group when compared to chronic hepatitis B groups (P < 0.05). These findings indicate that genetic variations in the TLR3 gene could affect the outcome of HBV infection.