Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial.

Importance: The protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown. Objective: To evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults. Design, Setting, and Participants: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021. Interventions: In cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection. Main Outcomes and Measures: The primary outcome was polymerase chain reaction-confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed. Results: In cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths. Conclusions and Relevance: In this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19-related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price. Trial Registration: isrctn.org Identifier: IRCT20210303050558N1.

Efficacy of Persian medicine herbal formulations (capsules and decoction) compared to standard care in patients with COVID-19, a multicenter open-labeled, randomized, controlled clinical trial.

Persian medicine has recommended clinical experiences and proper herbal remedies for prevention and treatment of microbial infections and respiratory diseases. An open-label, randomized, controlled, multicenter trial was conducted at five hospitals in Tehran and Isfahan provinces of Iran on 358 hospitalized adult patients. A total of 174 patients received standard care and 184 received herbal remedies (polyherbal decoction every 8 hr and two herbal capsules every 12 hr) plus standard care for 7 days. The primary clinical endpoint was the duration of hospital stay, and secondary outcomes were clinical improvement of symptoms based on self-assessment questionnaire. Results demonstrated that these natural decoction and capsules treatment plus routine care significantly decreased duration of hospital dyspnea (3.291 day vs. 6.468 days), accelerated clinical improvement, and decreased symptoms such as dry cough, dyspnea, muscle pain, headache, fatigue, anorexia, chills, runny nose, sputum cough, and vertigo in the treatment group compared with standard-care group. Significant effects of these polyherbal formulations on improving the symptoms of COVID-19 could be incredibly promising for managing this pandemic with acceptable tolerability.

Abdominal Pain as Extrapulmonary Presentation of Pneumonia in an Adult: A Case Report.

Pneumonia is considered as the main cause of abdominal pain in children whereas it presents mostly by respiratory symptoms in adults. Here we present a 71-year-old Iranian female who complained specifically of abdominal pain on admission to our emergency department. We had found nothing as an etiology in our first evaluations. After several hours chest pain was added to the symptoms and the following chest, X-Ray showed a consolidation in the right lung base. She was treated by pneumonia antibiotic regimen and discharged after seven days in a good clinical condition. In conclusion, pneumonia should be considered as a differential diagnosis of abdominal pain in adults as well as in children.

Breaking HIV News to Clients: SPIKES Strategy in Post-Test Counseling Session.

Breaking bad news is one of the most burdensome tasks physicians face in their everyday practice. It becomes even more challenging in the context of HIV+ patients because of stigma and discrimination. The aim of the current study is to evaluate the quality of giving HIV seroconversion news according to SPIKES protocol. Numbers of 154 consecutive HIV+ patients from Imam Khomeini Hospital testing and counseling center were enrolled in this study. Patients were inquired about how they were given the HIV news and whether or not they received pre- and post-test counseling sessions. Around 51% of them were men, 80% had high school education, and 56% were employed. Regarding marital status, 32% were single, and 52% were married at the time of the interview. Among them, 31% had received the HIV news in a counseling center, and only 29% had pre-test counseling. SPIKES criteria were significantly met when the HIV news was given in an HIV counseling and testing center (P.value<0.05). Low coverage of HIV counseling services was observed in the study. SPIKES criteria were significantly met when the HIV seroconversion news was given in a counseling center. The need to further train staff to deliver HIV news seems a priority in the field of HIV care and treatment.

Conventional- versus high-dose vancomycin regimen in patients with acute bacterial meningitis: a randomized clinical trial.

OBJECTIVE: Efficacy of the conventional- versus high-dose vancomycin regimen in patients with acute bacterial meningitis was compared. METHODS: In a randomized clinical trial 44 patients with acute bacterial meningitis were randomly assigned to the conventional- or high-dose vancomycin groups. Clinical and laboratory parameters were used for evaluation of response to the treatment regimens. RESULTS: In the high-dose group, leukocytosis and fever resolved significantly faster than those in the conventional group. Furthermore, the length of hospitalization was shorter and Glasgow Coma Scale at the end of 10th day was significantly lower in the high dose compared to the conventional group. Trend of creatinine clearance changes did not differ significantly between the two groups. CONCLUSION: In comparison to the conventional-dose regimen, the high-dose vancomycin regimen was associated with significantly more favorable clinical response without increase in the incidence of nephrotoxicity in patients with acute bacterial meningitis.

Elevated Vancomycin Trough Concentration: Increased Efficacy and/or Toxicity?

Vancomycin susceptibility of methicillin-resistant Staphylococcus aureus has been changed over time and its average minimum inhibitory concentration increased from 1.5 to 1.75 mg/L.A recently published guideline by the American Society of Health Pharmacist recommended a daily dose of 15-20 mg/Kg every 8 to 12 hours of vancomycin to achieve a trough concentration between 15-20 mg/L for treatment of severe infections. Medical records of 69 patients from infectious ward of Imam Khomeini hospital, with suspected or confirmed gram-positive infection who had at least one trough level of vancomycin, were evaluated regarding vancomycin therapeutic goal; efficacy and renal safety. Most of patients (60.6%) with severe infections did not achieve the recommended vancomycin trough level during treatment course. Time to normalization of the signs and symptoms of infection did not correlate with the patients' serum vancomycin trough levels. At the end of treatment course, there was no significant correlation between patients' creatinine clearance and vancomycin trough levels (P=0.32). However, patients'cratinine clearance showed a negatively significant correlation with trough level of vancomycin (P=0.01). Vancomycin induced nephrotoxicity was detected in 4.3% of the patients. These data showed that vancomycin trough level may not necessarily assure treatment success, and also it would not essentially predict the risk of vancomycin induced nephrotoxicity. However, more well designed studies with larger sample size needed for better clinical and practical judgment.

Diagnostic value of interferon-gamma assay in tuberculosis pericardial effusions: study on a cohort of Iranian patients.

Tuberculosis pericarditis as a potentially fatal complication of tuberculosis requires effective diagnosis and treatment. We evaluated the efficacy of interferon-gamma (IFN-gamma) and adenosine deaminase (ADA) for diagnosing tuberculosis pericarditis in a cohort of Iranian patients presenting with pericarditis. We enrolled 38 patients with presentation of pericarditis. All patients underwent diagnostic and therapeutic pericardiostomy with drainage and biopsy. Adenosine deaminase and interferon-gamma levels were determined in pericardial fluid samples of all patients. Pericardial tissue samples were submitted for histopathologic and microbiologic studies. Polymerase chain reaction (PCR) was performed on all pericardial fluid samples to detect Mycobacterium tuberculosis. From 38 patients with pericarditis, 7 cases were diagnosed as having tuberculosis pericarditis (18.4%). Mean concentration of interferon-gamma in tuberculosis group was significantly higher compared to non-tuberculosis group (69257 pg/l [range: 26600-148000] vs. 329 pg/l [range: 0-2200], P<0.000). Receiver operating characteristic (ROC) curve showed a value of 14400 pg/l as the cutoff point with a sensitivity of 100% and specificity of 100% for diagnosing tuberculosis pericardial effusion. Adenosine deaminase was not found to be significantly higher in tuberculosis group in comparison with non-tuberculosis causes of pericardial effusion (35.7 [range: 9-69] vs. 36.03 [range: 8-420], P=0.28). In this study interferon-gamma showed to be a valuable diagnostic test for detection of tuberculosis pericarditis among a cohort of Iranian patients. We suggest using interferon-gamma to diagnose tuberculosis pericarditis to make diagnose in case of suspicion. While in this study, adenosine deaminase measurement did not prove to have the characteristics of an accurate diagnostic test for tuberculosis pericarditis.

Attitudes, concerns, perceived impact and coping strategies for avian influenza among the first year medical students and interns in Tehran University of Medical Sciences.

To study and compare the attitudes, concerns, perceived impact and coping strategies for avian influenza (AI) among the first year medical students (FYMS) and interns in Tehran University of Medical Sciences. This was a cross sectional study carried out on FYMS (n=158) and interns (n=158) in 2008. The data collection tool was a questionnaire containing 37 questions in five parts. The three choices including "agree, disagree and unsure" were considered for all questions. We used Chi-square and Fisher's exact tests for analysis. Most of FYMS and interns (78.2%) believed their health would be depended on the care of their selves. Most of them (95.3%) believed that if they knew avian flu better, they could be more prepared for it. The majority were concerned about risk to their health from their work (62.7%). Most (67.7%) accepted the risk and only 5 (1.6%) would consider stopping work. For non-work concerns, 70.9% were concerned about their spouses/sexual partners and 65.8% about their children. For perceived impact, most (66.5%) believed that they would feel stressed at work and the majority (74.4%) expected an increased workload. FYMS and interns have positive attitudes but major concerns about contracting AI and its relation to medical practice.

Prevalence and correlates of co-infection with human immunodeficiency virus and hepatitis C virus in male injection drug users in Iran.

OBJECTIVE: Aim of the study was to evaluate the HIV and hepatitis C virus (HCV) coinfection and associated risk behaviors among Injection Drug Users in Detention, Tehran, Iran. METHODS: A cross-sectional survey included 499 male Injection Drug Users arrested by police during a predetermined police sweep in Tehran (February, 2006). At the temporary detention center, they were screened using a urine test and a physical examination for injection marks. Those who were identified as injectors were sent to the rehabilitation center for 3 months. A questionnaire was filled out for each individual by interview. Blood specimens were collected for HIV and HCV testing. The variables associated with HIV/HCV coinfection at a significance level of P<0.10 were considered in multivariate analysis. RESULTS: Of the 417 participants, 100 (24.0%) had HIV/HCV coinfection (95%CI 19.9 - 28.4). Factors independently associated with HIV/HCV coinfection included history of using opioid in jail, and age (P<0.05). There were not any association between other demographic characteristics (marital status, birthplace, residence, and education), type and years of drug abuse, age of first injection, years of injection, sharing needles inside and outside of jail, injection in jail, history of tattooing, any sexual behavior, and history of sexually transmitted diseases with HIV/HCV coinfection (P>0.05). CONCLUSIONS: This study supports that incarceration is contributing to the increased spread of HIV/HCV coinfection. So, there is urgent need for effective harm reduction programs, particularly among incarcerated Injection Drug Users.