Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial.

Background: We conducted a phase III, non-inferiority trial comparing safety and efficacy of RCP recombinant spike protein Covid-19 vaccine to BBIBP (Sinopharm). Methods: Adult Iranian population received RCP or BBIBP in a randomized, double blind and an additional non-randomized open labeled trial arms. Eligible participants signed a written informed consent and received two intramuscular injections three weeks apart. In the randomized arm, an intranasal dose of vaccine or adjuvant-only preparation were given to the RCP and BBIBP recipients at day 51 respectively. Participants were actively followed for up to 4 months for safety and efficacy outcomes. Primary outcome was PCR + symptomatic Covid-19 disease two weeks after the second dose. The non-inferiority margin was 10% of reported BBIBP vaccine efficacy (HR = 1.36). Results: We recruited 23,110 participants (7224 in the randomized and 15,886 in the non-randomized arm). We observed 604 primary outcome events during 4 months of active follow-up including 121 and 133 in the randomized and 157 and 193 cases in the non-randomized arms among recipients of RCP and BBIBP respectively. Adjusted hazard ratios for the primary outcome in those receiving RCP compared with BBIBP interval were 0.91 (0.71-1.16) and 0.62 (0.49-0.77) in the randomized and non-randomized arms respectively. The upper boundary of 99.1% confidence interval of HR = 0.91 (0.67-1.22) remained below the margin of non-inferiority in the randomized arm after observing the early stopping rules using O'Brien Fleming method. Conclusion: Our study showed that the RCP efficacy is non-inferior and its safety profile is comparable to the BBIBP.

Signal amplification of a quartz crystal microbalance immunosensor by gold nanoparticles-polyethyleneimine for hepatitis B biomarker detection.

The procedures currently used for hepatitis B (HB) detection are not suitable for screening, clinical diagnosis, and point-of-care testing (POCT). Therefore, we developed and tested a QCM-based immunosensor by surface modification with AuNP-PEIs to amplify the signal and provide an oriented-immobilization surface. The AuNP-PEIs were characterized by ICP-Mass, UV/Vis, DLS, FE-SEM, and ATR-FTIR. After coating AuNP-PEIs on the gold electrode surface, anti-HBsAg antibodies were immobilized using NHS/EDC chemistry based on response surface methodology (RSM) optimization. The efficiency of the immunosensor was assessed by human sera and data were compared to gold-standard ELISA using receiver-operating-characteristic (ROC) analysis. FE-SEM, AFM, EDS, and EDS mapping confirmed AuNP-PEIs are homogeneously distributed on the surface with a high density and purity. After antibody immobilization, the immunosensor exhibited good recognition of HBsAg with a calibration curve of ∆F = - 6.910e-7x + 10(R2 = 0.9905), a LOD of 1.49 ng/mL, and a LOQ of 4.52 ng/mL. The immunosensor yielded reliable and accurate results with a specificity of 100% (95% CI 47.8-100.0) and sensitivity of 100% (95% CI 96.2-100.0). In conclusion, the fabricated immunosensor has the potential as an analytic tool with high sensitivity and specificity. However, further investigations are needed to convert it to a tiny lab-on-chip for HB diagnosis in clinical samples.

A Comparison of Boron Supplement and Tamsulosin as Medical Expulsive Therapy for Urinary Stones After Extracorporeal Shock Wave Lithotripsy: a Randomized Controlled Clinical Trial.

Treatment with alpha-blockers has been used in many studies to facilitate stone clearance after extra-corporeal shock wave lithotripsy (ESWL), based on mediating ureteral wall relaxation. Ureteral wall edema is another barrier against the stone passage. We aimed to compare the effectiveness of boron supplement (due to its anti-inflammatory effect) and tamsulosin in the passage of stone fragments after ESWL. Eligible patients after ESWL were randomly assigned to two groups and were treated with boron supplement (10 mg/BD) or tamsulosin (0.4 mg per night) for 2 weeks. The primary outcome was the stone expulsion rate according to the remained fragmented stone burden. The secondary outcomes were the time of stone clearance, pain intensity, drug side effects, and the need for auxiliary procedures. In this randomized control trial, 200 eligible patients were treated with boron supplement or tamsulosin. Finally, 89 and 81 patients in the two groups completed the study, respectively. The expulsion rate was 46.6% in the boron and 38.7% in the tamsulosin group, which there was no statistically significant difference between the two groups (p = 0.003), as well as the time of stone clearance (7.47 ± 22.4 vs 6.52 ± 18.45, days, p = 0.648, respectively), after 2-week follow-up. Moreover, pain intensity was the same in both groups. No Significant side effects were reported in the two groups. Boron supplement could be effective as adjuvant medical expulsive therapy after ESWL with no significant side effects in short-term follow-up. Iranian Clinical Trial Registration number and date of registration: IRCT20191026045244N3, 07/29/2020.

Tropheryma whipplei intestinal colonization in immunocompromised children in Iran: a preliminary study.

Aim & method:Tropheryma whipplei causes Whipple's disease. Children are reservoirs of this bacterium. The aim of this study was to investigate the presence of T. whipplei in children with immunodeficiency in central Iran from July 2018 to February 2019. Stool samples were tested by SYBR Green and Taq-Man real-time PCR assays. For confirmation, the isolated DNA was sequenced. Results: One hundred and thirty children were enrolled. Acute lymphocytic leukemia was the most reported immunodeficient disease (77%), followed by non-Hodgkin lymphoma and retinoblastoma. Thirteen (10%) children had T. whipplei DNA in the stool; 11.4% of the children under 5 years old were positive. Conclusion: This is the first study showing the circulation of T. whipplei in Iran.

Factors Affecting Prevalence of Urinary Tract Infection in Neonates with Unexplained Hyperbilirubinemia: A Systematic Review and Meta-Analysis Study in Iran.

BACKGROUND: The prevalence and risk factors of urinary tract infection (UTI) in neonates with unexplained hyperbilirubinemia are not studied thoroughly. Since the prevalence of UTI is highly variable in different areas and countries, this study aimed to review the existing data of Iranian neonates with UTI presented with unexplained hyperbilirubinemia. METHODS: This study is a meta-analysis of Iranian newborns with unexplained hyperbilirubinemia. We identified all studies indexed in international (Web of Science, PubMed, Scopus, Google Scholar) and national (Science Information Database, Magiran) databases from 2000-2018. Search terms included: Urinary Tract Infections OR UTI AND urine OR culture OR microbio, jaundice OR icter OR hyperbili, AND Iran. RESULTS: Overall, 4210 neonates from 17 studies were included. The pooled prevalence of UTI in neonates with unexplained hyperbilirubinemia was 6.81% (95% CI: 4.86-8.77). Considering the subgroups analyses; the prevalence of UTI was higher in the prolonged vs. not-prolonged state (8.34% vs. 4.00%), low birth weight vs. normal birth weight (7.81% vs. 4.51%), and exclusive vs. non-exclusive breastfeeding (8.84% vs. 4.72%). Male gender and low birth weight increased the risk of UTI about two times compared to the female gender and normal birth weight, respectively. The results of the analyses in neonates with unconjugated hyperbilirubinemia also showed the above-mentioned subgroup differences. CONCLUSION: Due to considerable prevalence of UTI in neonates with unexplained hyperbilirubinemia and risk factors in this age group, investigation for UTI is essential for the workup in this situation.

Effect of vitamin D supplementation on 24-hour urine calcium in patients with calcium Urolithiasis and vitamin D deficiency

ABSTRACT Purpose: Hypercalciuria is one of the risk factors for calcium kidney stone formation (the most common type of urinary stones). Although vitamin D deficiency is prevalent among urolithiasis patients, the effect of vitamin D supplementation on urine calcium in these patients is still unclear. Materials and Methods: In this retrospective study, medical and laboratory tests records of 26 patients with recurrent calcium kidney stones and vitamin D deficiency treated with 50000IU vitamin D per week for 8-12 weeks were analyzed. The changes in 24-hour urine calcium (24-h Ca), serum 25-hydroxyvitamin D (25 (OH) D), serum parathormone (PTH), other 24-hour urine metabolites and calculated relative supersaturations of calcium oxalate (CaOxSS), calcium phosphate (CaPSS) and uric acid (UASS) were assessed. Moreover, correlations between changes in 24-h Ca and other aforementioned variables were assessed. Results: Serum 25 (OH) D and 24-h Ca increased after vitamin D supplementation, while serum PTH decreased (p < 0.001, for all analyses). The levels of 24-hour urine sodium and urea increased significantly (p = 0.005 and p = 0.031, respectively). The levels of CaOxSS and CaPSS increased, but the changes were not significant (p = 0.177, and p = 0.218, respectively). There were no correlations between the changes in 24-h Ca and serum 25 (OH) D or PTH. Conclusions: The result of current study suggests that although urine Ca increased in vitamin D supplemented patients, this increase was not associated with the increase in serum vitamin D and may be due to other factors such as dietary factors. Further randomized clinical trials considering other factors associated with urine Ca are warranted.

Effect of vitamin D supplementation on 24-hour urine calcium in patients with calcium Urolithiasis and vitamin D deficiency.

PURPOSE: Hypercalciuria is one of the risk factors for calcium kidney stone formation (the most common type of urinary stones). Although vitamin D deficiency is prevalent among urolithiasis patients, the effect of vitamin D supplementation on urine calcium in these patients is still unclear. MATERIALS AND METHODS: In this retrospective study, medical and laboratory tests records of 26 patients with recurrent calcium kidney stones and vitamin D deficiency treated with 50000IU vitamin D per week for 8-12 weeks were analyzed. The changes in 24-hour urine calcium (24-h Ca), serum 25-hydroxyvitamin D (25 (OH) D), serum parathormone (PTH), other 24-hour urine metabolites and calculated relative supersaturations of calcium oxalate (CaOxSS), calcium phosphate (CaPSS) and uric acid (UASS) were assessed. Moreover, correlations between changes in 24-h Ca and other aforementioned variables were assessed. RESULTS: Serum 25 (OH) D and 24-h Ca increased after vitamin D supplementation, while serum PTH decreased (p < 0.001, for all analyses). The levels of 24-hour urine sodium and urea increased significantly (p = 0.005 and p = 0.031, respectively). The levels of CaOxSS and CaPSS increased, but the changes were not significant (p = 0.177, and p = 0.218, respectively). There were no correlations between the changes in 24-h Ca and serum 25 (OH) D or PTH. CONCLUSIONS: The result of current study suggests that although urine Ca increased in vitamin D supplemented patients, this increase was not associated with the increase in serum vitamin D and may be due to other factors such as dietary factors. Further randomized clinical trials considering other factors associated with urine Ca are warranted.

Serological survey of tularemia among butchers and slaughterhouse workers in Iran.

BACKGROUND: Tularemia is a zoonotic disease caused by the Gram-negative bacterium Francisella tularensis. Human infections often occur through manipulation of infected animals or animal carcasses. METHODS: In this study, we determined the tularemia seroprevalence in butchers and slaughterhouse workers in 10 counties of Sistan and Baluchestan Province in Iran. RESULTS: A mean seroprevalence of 6.5% for IgG antibodies against F. tularensis was seen. The highest seropositivity rates were observed in the counties of Zabol and Nikhshahr. There was no difference in the seroprevalence rates between butchers and slaughterhouse workers (p=0.25). CONCLUSION: These data suggest that tularemia is endemic in Sistan and Baluchestan Province in Iran.

Vulnerability of homeless people in Tehran, Iran, to HIV, tuberculosis and viral hepatitis.

BACKGROUND: Homeless people are at risk of contracting communicable infectious diseases, as they indulge in risky behaviours and lifestyle. This study was conducted to determine the prevalence of the aforementioned infections and related risk behaviours among homeless people in Tehran. METHODS: In this study a convenience sample of 593 homeless individuals was studied. The ELISA method was used for the detection of HIV, HCV and HBV. Clinical symptoms, sputum cultures, acid fast bacilli smears, and chest X-rays were used to identify active pulmonary tuberculosis, and the Interferon Gamma Release Assay (IGRA) test was used to identify latent tuberculosis. RESULTS: The prevalence of HIV, HBV, HCV and latent tuberculosis was 3.4%, 2.6%, 23.3% and 46.7%, respectively. Active pulmonary tuberculosis was found in 7 persons (1.2%). Injection drug use was an independent risk factor for HIV, HCV and HBV infections. Older people had a higher proportion of Mycobacterium tuberculosis infection (OR: 2.6, 95%CI: 1.9, 3.7) and HCV positivity (OR: 1.7, 95% CI: 1.1, 2.5). CONCLUSION: Our findings highlighted that much more attention needs to be paid to the health of homeless people.

Seroepidemiological survey of tularemia among different groups in western Iran.

BACKGROUND: The first human case of tularemia in Iran was reported in 1980 and there have been no subsequent reports of tularemia in the country. The aim of this study was to carry out a survey of tularemia among different groups in the province of Kurdistan in western Iran. METHODS: The following information was collected by means of an in-house questionnaire: participant demographic characteristics, exposure to risks, and use of appropriate personal protective equipment and disinfectant in their occupation. A blood sample was collected from each participant. Sera were tested using an ELISA kit (Virion\Serion) to detect specific IgG antibodies against Francisella tularensis. RESULTS: Of a total of 250 serum samples, 14.40% had anti-tularemia IgG antibodies. The highest seroprevalence was found in hunters (18%) and the lowest in health care workers (12%). Age had a significant positive association with tularemia seroprevalence (p<0.001). The seroprevalence of tularemia in people exposed to foxes (hunting or eating the meat) (25%) was significantly higher than in others (8.65%) (p = 0.01). CONCLUSIONS: According to the findings of this study, it is highly recommended that physicians and health care workers are informed about bacteria circulating in this area. By sensitizing the health system, it is expected that some cases of the clinical disease will be reported in the near future. Similar studies in other parts of the country and on domestic and wild animals will clarify the epidemiology of tularemia in Iran.

Seroepidemiological survey of Q fever and brucellosis in Kurdistan Province, western Iran.

Given that the there is little information about the current status of brucellosis and Q fever in most parts of Iran, the aim of this study was to assay the seroprevalence of these two diseases in high-risk populations of Kurdistan Province in western Iran. Two hundred fifty sera samples were collected from hunters and their families, butchers, health care workers, and those referred to medical diagnostic laboratories in the southwestern regions of Kurdistan Province. Sera were tested to detect specific immunoglobulin G (IgG) antibodies against brucellosis and Coxiella burnetii (phase I and II). The seroprevalence of brucellosis and Q fever (C. burnetii IgG phase I and II) was 6.4% and 27.83% (20% and 14.52%), respectively. The highest seroprevalence of Q fever (38%) and brucellosis (12%) was seen in butchers, who handled cattle, sheep, and goats during their work. Age had a significant positive association with Q fever seropositivity (p=0.04). The seroprevalence of Q fever was higher in those people who had been in employment for more than 10 years (21.88%) compared to others (7.79%) (p=0.02). The keeping of animals (p=0.03), hunting and eating the meat of wild animals (p=0.02), and not disinfecting hands and faces after working (for health care workers and butchers) (p=0.02) were risk factors for Q fever seropositivity. This study showed a relatively high seroprevalence of brucellosis and Q fever in high-risk populations of Kurdistan Province. It is suggested that complementary studies be carried out in other parts of western Iran to clarify the epidemiological aspects of these diseases.

Seroepidemiological survey of Crimean-Congo hemorrhagic fever among sheep in Mazandaran province, northern Iran.

Crimean-Congo hemorrhagic fever (CCHF) is a disease prevalent among humans and animals and is endemic in Iran. Although CCHF has been reported in all of its neighboring provinces, in Mazandaran in northern Iran there have been no reports of any cases of human infection. This research has been carried out to clarify the epidemiological aspects of CCHF infection among sheep in various geographical regions of Mazandaran province. In this survey, 270 blood samples were collected from sheep in eastern, central, and western Mazandaran between 2010 and 2011, and the specific ELISA test for CCHF virus was carried out on the blood samples in the National Reference Laboratory in the Pasteur Institute, Tehran, Iran. The CCHF infection rate according to this study was 3.7%. A weak statistical relationship (p=0.063) was seen between the different geographical regions, with a gradual decrease in the infection rate noted, stretching from the eastern to the western portions of the province (eastern 6.8%, central 2.8%, and western 0%). Older sheep were 2.7 times more likely to be infected with the virus (OR 2.70; 95% CI 1.50,4.87; p<0.001). As the infection rate in Mazandaran is low among sheep, and as yet there have been no reports of human infection in this province, CCHF disease is not considered a serious health problem in Mazandaran. It is recommended that further research be carried out on other animals, high-risk human groups, and ticks, in order to more completely reveal the status of the disease in this province.