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.

The effectiveness of colistin/levofloxacin compared to colistin/meropenem in the treatment of ventilator-associated pneumonia (VAP) caused by carbapenem-resistant Acinetobacter baumannii: a randomized controlled clinical trial.

Background and purpose: The treatment of ventilator-associated pneumonia (VAP) caused by carbapenem-resistant Acinetobacter baumannii (CRAB) is still a great challenge. This study evaluated the effectiveness of the colistin/levofloxacin regimen compared to the usual colistin/meropenem regimen in the treatment of patients with VAP caused by CRAB. Experimental approach: The patients with VAP were randomly assigned to experimental (n = 26) and control (n = 29) groups. The first group received IV colistin 4.5 MIU every 12 h + levofloxacin 750 mg IV daily, and the second group received IV colistin with the same dose + meropenem 1 g IV every 8 h for 10 days. The clinical (complete response, partial response, or treatment failure) and microbiological responses at the end of the intervention were recorded and compared between the two groups. Findings/Results: The complete response rate was higher (n = 7; 35%) and the failure rate was lower (n = 4; 20%) in the experimental group than in the control group (n = 2; 8%, and n = 11; 44%, respectively), but the differences were not statistically significant. Even though the microbiological response rate was higher in the experimental group (n = 14; 70%) than in the control group (n = 12; 48%), the difference was not statistically significant. The mortality rate was 6 (23.10%) and 4 patients (13.8%) in the experimental and control groups, respectively (P = 0.490). Conclusion and implication: The levofloxacin/colistin combination can be considered an alternative regimen to meropenem/colistin in the treatment of VAP caused by CRAB.

Phaeohyphomycosis caused by Neoscytalidiumdimidiatum in a COVID-19 patient.

BACKGROUND: Neoscytalidiumdimidiatum is an opportunistic dematiaceous fungus belonging to the class Dothideomycetes. CASE REPORT: We report a case of N. dimidiatum cerebral phaeohyphomycosis post COVID-19 infection in a 32-year-old male from Iran. The causative agent was identified by cytopathology, routine mycological methods, and DNA sequencing of the internal transcribed spacer (ITS) region of rDNA. Apart from COVID-19 complications and the corticosteroid therapy, no underlying condition was diagnosed. The symptoms suggesting the fungal infection were shown two weeks after being discharged from COVID-19 hospital stay. Magnetic resonance of the brain showed a multi-focal central nervous system infection. The delayed identification of the fungus and, thus, a late starting of the antifungal treatment with amphotericin B, might have affected the patient outcome as he finally died. CONCLUSIONS: Considering the rare incidence of N. dimidiatum infections, this case should aware us about them, leading to a timely antifungal management.

Phaeohyphomycosis caused by Neoscytalidiumdimidiatum in a COVID-19 patient / Feohifomicosis producida por Neoscytalidium dimidiatum en un paciente con COVID-19

Background: Neoscytalidiumdimidiatum is an opportunistic dematiaceous fungus belonging to the class Dothideomycetes.Case reportWe report a case of N. dimidiatum cerebral phaeohyphomycosis post COVID-19 infection in a 32-year-old male from Iran. The causative agent was identified by cytopathology, routine mycological methods, and DNA sequencing of the internal transcribed spacer (ITS) region of rDNA. Apart from COVID-19 complications and the corticosteroid therapy, no underlying condition was diagnosed. The symptoms suggesting the fungal infection were shown two weeks after being discharged from COVID-19 hospital stay. Magnetic resonance of the brain showed a multi-focal central nervous system infection. The delayed identification of the fungus and, thus, a late starting of the antifungal treatment with amphotericin B, might have affected the patient outcome as he finally died.ConclusionsConsidering the rare incidence of N. dimidiatum infections, this case should aware us about them, leading to a timely antifungal management. (AU)

Antecedentes: Neoscytalidiumdimidiatum es un hongo dematiáceo oportunista perteneciente a la clase Dothideomycetes.Caso clínicoPresentamos un caso de feohifomicosis cerebral por N. dimidiatum posterior a infección por COVID-19 en un paciente iraní de 32 años de edad. El microorganismo responsable fue identificado por citopatología, métodos rutinarios de laboratorio y secuenciación del ADN del espaciador transcrito interno (ITS) del ADNr. Aparte de las complicaciones asociadas a la COVID-19 y al uso de corticoides, el enfermo no presentaba enfermedades subyacentes. Los síntomas indicativos de infección fúngica fueron observados dos semanas después de que el paciente recibiera el alta hospitalaria por la COVID-19. La resonancia magnética cerebral mostró una infección multifocal en el sistema nervioso central. El retraso en la identificación del hongo responsable y, consecuentemente, en la instauración del tratamiento antifúngico con anfotericina B, pudo afectar a la evolución del paciente, ya que este finalmente falleció.ConclusionesA pesar de la escasa incidencia de las infecciones por N. dimidiatum, este caso debe alertarnos sobre su existencia para instaurar así el tratamiento antifúngico conveniente a la mayor brevedad. (AU)

Protective effects of salep against isoniazid liver toxicity in wistar rats.

INTRODUCTION: Isoniazid is a drug for treatment of tuberculosis. One of the main side effects of this drug is hepatotoxicity, which is a major cause of treatment interruption in tuberculosis. This study is about the preventive effect of Salep on this side effect of isoniazid. MATERIALS AND METHODS: This study is an experimental study in which the preventive effect of salep on isoniazid hepatotoxicity is evaluated. In this study 56 rats were randomly placed in 7 eight members groups including: control group, sham, isoniazid and four isoniazid/salep groups. At the end of the study the laboratory criteria and histological features of liver toxicity were compared in different mentioned groups. RESULTS: Significant lower serum levels of liver enzymes, billirubin, MDA and TOC; and significant higher levels of TAC and total proteins, were revealed in isoniazid/salep group in compare to isoniazid alone group.In addition, histological studies had not showed liver injury in isoniazid/salep group, while there was significant liver injury in isoniazid alone group. CONCLUSIONS: Orchid extract (salep), probably because of its antioxidant properties, prevent the destructive effects of isoniazid on the liver.

Toxoplasma gondii Type I, predominant genotype isolated from sheep in South of Iran.

AIM: This study was performed to determine the genetic diversity of Toxoplasma gondii in sheep using nested-polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) in Southern Iran. MATERIALS AND METHODS: The tissue samples of diaphragm and heart from 125 sheep were collected from the main slaughterhouses of Jahrom district in South of Fars province, Iran, between Aprils and June 2013. The DNA were extracted and analyzed by nested-PCR using specific primers for SAG2 and GRA6 loci. RFLP was used to classify strains into one of the three major lineages of T. gondii. RESULTS: T. gondii Type I was predominant in this area. The data obtained from both loci demonstrated that the frequency of each genotype was 72% Type I, 2.4% Type III, 7.2% mixed Type I and II, 16.8% mixed Type I and III, 0.8% mixed Type II and III, and 0.8% mixed Type I, II and III. CONCLUSIONS: Although the previously published data indicated that Type II is the predominant T. gondii genotype in sheep in the other parts of the world, this study showed that genotype I is the dominant genotype of T. gondii in the southern Iran; however, other genotypes were detected. High diversity of T. gondii genotypes including mix genotypes in lambs is of importance for the public health. These studies depict a new mapping of T. gondii genotypes pattern which could be very helpful in toxoplasmosis control and prevention.

Protective effect of salep on liver.

BACKGROUND: Salep is used for various purposes in food industries and traditional medicine. Therefore, evaluation of its effect on the liver seems to be necessary. OBJECTIVES: The aim of this study was to assess salep effect on liver. MATERIALS AND METHODS: In this experimental study, various concentrations of Salep were intraperitoneally administered to five groups of Wistar rats (control, placebo and 20, 40 and 80 mg/kg salep). After one month, liver enzymes and liver tissue were evaluated and compared between different groups. RESULTS: Significant decreased level of liver enzymes, MDA (Malondialdehyde) and TOC (Total Oxidation Capacity) were found in various concentrations of salep administration. On the other hand, a significant increase was found in TAC (Total Antioxidant Capacity) level with various doses of salep. CONCLUSIONS: Elevated level of total protein and albumin and decreased level of liver enzyme by salep extract were found in this study. Therefore, this plant may be a useful medicine for patients with liver diseases.

Seroepidemiology of Toxoplasma infection in blood donors in Jahrom District, Southern Iran

Objective: To identify the anti-Toxoplasma antibodies from blood donors who referred to blood transfusion bases of Jahrom County, using ELISA method. Methods: Based on the prevalence and characteristics method, 400 serum samples were collected from blood donors referred to Jahrom blood transfusion bases, Southern Iran, during 2010–2011, designed at testing by ELISA. IgM and IgG antibodies against Toxoplasma gondii were tested using ELISA kits (Dia-Pro) on serums. The data were analysed by SPSS 19 software. Results: Review of 400 cases, 54 of them were IgG positive for parasites (13.5%) and 346 of those with negative IgG (86.5%). In IgM examination, 1.75%of them have been positive IgM (7 cases) and 98.25% of them were IgM negative (393 cases). By comparing the different group ages, 40–50 year age group had the highest prevalence of IgG positive (17.9%) and the age group of 30–40 years had the highest incidence of IgM negative (2.5%). Conclusions: Due to the serological infection rate of toxoplasmosis obtained from this study, toxoplasmosis should be considered as a significant transfusion risk factor in Jahrom and also in any region with similar situations.

Occult hepatitis B demonstrated by anti-HBc and HBV DNA in HIV-positive patients.

BACKGROUND: In patients who are hepatitis B virus (HBV) DNA-positive, but HBV surface antigen (HBsAg) -negative, the infection is referred to as occult hepatitis B infection (OBI). Occult HBV infection is harmful when other liver diseases are present, and can aggravate liver damage in in patients with chronic liver diseases. In human immunodeficiency virus (HIV) infection the suppression of viral replication by the immune system might be inactivated, and classical HBV infection in OBI patients may occur. Health care professionals should be aware of OBI in HIV patients. The routine test for HBV infection in Iran is the enzyme-linked immunosorbent assay for the HBV surface antigen (ELISA HBsAg); therefore, the aim of this study was to evaluate the prevalence of OBI in Iranian HIV patients. METHODS: This cross-sectional study was conducted in 2012 on sera from all the known and accessible HIV patients in Jahrom and Fassa, two cities in southern Iran. All samples were tested for the HBsAg, HBV core antibody (HBcAb). All the results were analyzed using SPSS. RESULTS: Of the 91 patients, seven (7.7%) were HBsAg-positive and forty-five (49.5%) were HBcAb-positive. In patients with negative HBsAg (84 patients), 39 (46.4%) were HBcAb positive and 53 (63%) were positive for HBV DNA. CONCLUSION: The prevalence of HBV infection is relatively high in HIV patients, and more accurate tests than those presently in use should be used for diagnosis.

Molecular Survey on Detection of Leishmania Infection in Rodent Reservoirs in Jahrom District, Southern Iran.

BACKGROUND: Zoonotic Cutaneous Leishmaniasis (ZCL) is endemic in many parts of Iran. Recently its incidence is considerable in different parts of Jahrom district, in Fars Province, southern Iran. The aims of our study were to investigate the prevalence of leishmania infection, and identify and characterize the Leishmania species present, among the rodents by molecular methods in a new endemic focus of ZCL, in an urban and rural area of the Jahrom district, Fars Province, southern Iran. METHODS: From May to November 2010), 55 rodents in four regions of Jahrom focus were caught and checked for leishmania infection by the microscopical examination of liver, spleen, ears, and footpads' smears. RESULTS: Overall 18 Meriones persicus, 15 Tatera indica, 14 Mus musculus, and 8 Rattus rattus were caught. Totally, four (16.5%) and two (13.3%) of the Me. persicus and Ta. indica, but only one of Mu. musculus and Ra. rattus were found smear-positive for leishmania amastigotes, respectively. In the nested-PCR assay 8 (14.6%) smears were found positive for Leishmania major, none was found positive for any other Leishmania species. Sequencing based detection of Leishmania confirmed the microscopic and PCR findings. All positive specimens were shown 95-96% similarity with L. major Friedlin. CONCLUSION: Tatera indica and Me. persicus are incriminated as the main 'reservoir' hosts of L. major in the rural area of Jahrom, moreover, Mu. musculus and Ra. rattus have the minor but remarkable role in the maintenance of the disease in the urban regions of Jahrom focus.

Mucormycosis after scorpion sting: case report.

Mucor is a fungus, which give rise to opportunistic infection in immunocompromised patients. We described a 55-year-old immunocompetent woman with cutaneous mucormycosis after scorpion sting. Mucormycosis may happen in patients with intact immunity and is not allocated only to patients with immune deficiency.

Hepatitis E virus and serum level aminotransferases in blood donors.

BACKGROUND: Hepatitis E virus (HEV) infection is a self-limiting viral infection that can lead to severe complications and death. In different regions the epidemiology of this infection varies. In this study we evaluated the seroepidemiology of hepatitis E infection in Jahrom, a city in southern Iran. METHODS: This was a cross-sectional descriptive study of serum samples from 477 subjects, including 30 females and 447 males. HEV immunoglobulin G (IgG) and immunoglobulin M (IgM) were measured by enzyme-linked immunosorbent assays (ELISA). Alanine transaminase (ALT) and aspartate transaminase (AST) levels were also determined. Four hundred forty-seven subjects were male and 30 were female. Subjects were classified by age and sex. RESULTS: One woman (3.3%) and 25 men (5.5%) were positive for HEV antibodies (IgG and/or IgM). There was found an association between serum level of aminotransferases and seropositivity for HEV. CONCLUSION: The result of this study indicates that HEV is an etiological factor for hepatitis in this area of IRAN. The cost benefit of active immunization in endemic regions should be evaluated because an outbreak could have tragic consequences.

Evaluation of anti-varicella antibody in young women before their marriage: A sero-epidemiologic study in Iran.

BACKGROUND: Chickenpox during pregnancy can cause severe complications in both the mother and her baby. However, no complications will occur in a mother with proper immunity. Therefore, physicians and health systems can make better decisions when they know the immunologic status of the women in a community. OBJECTIVES: We conducted this study to clarify the Varicella zoster virus (VZV) immune status of engaged women in Iran. STUDY DESIGN: This cross-sectional descriptive study was carried out on 334 young women who intended to marry between 2006 and 2008. The subjects' VZV-immunoglobulin G (IgG) and demographic characteristics were evaluated. RESULTS: The mean age of the subjects was 20.5+/-4.9 years and their mean anti-varicella value was 86.22+/-71.05 U ml(-1). Of 333 young women studied, 242 (72.7%) were positive, 89 (26.7%) were negative for anti-varicella antibody and two were equivocal (0.6%). The rate of immunity increased with increasing age; all of the subjects over 35 years of age were immune to varicella. The positive predictive value (PPV) for self-reported history of chickenpox in subjects was estimated to be 79.5% and the negative predictive value (NPV) of a negative or uncertain disease history was 30.5%. A higher immune ratio was seen in women with more siblings. CONCLUSIONS: The difference in the proportion of VZV-immune people in our country versus developed countries may be due to the introduction of varicella vaccine in developed nations. The mean age at first pregnancy in Iran is 25.7 years and the results of our study indicate that more than one-fourth of these women are not immune to varicella. We therefore recommend vaccination in women, especially those who are under 35 years of age. Number of siblings and positive history of varicella infection may be the indicators to determine the immunity level of a pregnant woman who has had contact with a patient with chickenpox.

Effects of camel thorn distillate on recurrent oral aphthous lesions.

BACKGROUND: Near 20 % of people suffer from recurrent oral aphthous ulcers. These painful ulcers are found on the oral mucosa. We conducted this study to evaluate the effect of the camel thorn distillate on this condition. PATIENTS AND METHODS: 93 patients with recurrent aphthous ulcers were selected and divided into two groups. One group was given a placebo (n = 44) and the other was given camel thorn distillate (n = 49). The diameter of the lesions and the severity of the pain were measured 3, 5, 7, 10 and 14 days after initiation of therapy. The lesion diameters and pain scores of the two groups were compared using the t-test. RESULTS: Complete resolution time ranged from 3 to 7 days (mean = 4.02) in the group treated with camel thorn distillate, whereas in the control group, complete resolution time ranged from 7 to 14 days (mean = 8.9, p < 0.001). CONCLUSIONS: The efficacy of camel thorn distillate is comparable to that of other drugs used to treat oral aphthous ulcers. Its therapeutic effect may be due to the flavanones (alhagitin and alhagidin) that are present in this plant.

Fibrinogen as a risk factor for premature myocardial infarction in Iranian patients: a case control study.

BACKGROUND: Premature myocardial infarction with life-threatening complications may become epidemic in some Asian and African countries and especially Iran. Fibrinogen is considered as one of the probable risk factors of myocardial infarction. The aim of our study was to assess fibrinogen levels as an etiology of premature myocardial infarction in young Iranian men. FINDINGS: A case-control study was conducted between May 2005 and May 2007 to investigate the association between serum total fibrinogen level and myocardial infarction in men aged younger than 55 years admitted to the cardiac care units of Peymanieh and Motahari Hospitals affiliated to Jahrom University of Medical Sciences, Iran. The mean age of patients was 45.2 +/- 4 years in patients with premature myocardial infarction and 47.06 +/- 4.5 years in the control group (p = 0.085). There were no statistically significant relationships between the two groups in history of premature myocardial infarction in their first-degree relatives (p = 0.05), cigarette smoking (p = 0.46), diabetes (p = 0.49), or hypertension (p = 1). The mean plasma fibrinogen in patients (354.9 +/- 60 mg/dL) was elevated markedly compared with the control group (329 +/- 73 mg/dL). Hyperfibrinogenemia (>340 mg/dL) was detected in 81.8% of patients and 57.5% of controls (95% confidence interval, odds ratio = 3.3; p = 0.036). CONCLUSION: This study introduced fibrinogen as a risk factor for premature coronary artery disease in Iranian men.

Cutaneous leishmaniasis associated with visceral leishmaniasis in a case of acquired immunodeficiency syndrome (AIDS).

INTRODUCTION: Leishmania/human immunodeficiency virus (HIV) coinfection is emerging as an increasingly frequent and extremely serious new disease. Although many reports have described the association of visceral leishmaniasis and AIDS, cutaneous leishmaniasis associated with AIDS is very uncommon. CASE SUMMARY: We describe a case of visceral leishmaniasis/HIV coinfection associated with cutaneous Leishman body-positive lesions in a patient from Jahrom, a city in Fars province in Iran. CONCLUSION: Our case demonstrated that it is better to evaluate the diagnosis of visceral leishmaniasis in patients who present with cutaneous leishmaniasis and HIV infection.