Reactogenicity within the first week after Sinopharm, Sputnik V, AZD1222, and COVIran Barekat vaccines: findings from the Iranian active vaccine surveillance system.

BACKGROUND: This study aimed to evaluate the reactogenicity effects of COVID-19 vaccines, used in Iran. METHODS: At least 1000 people were followed up with phone calls or self-report in a mobile application within 7 days after vaccination. Local and systemic reactogenicities were reported overall and by subgroups. RESULTS: The presence of one or more local and systemic adverse effects after the first dose of vaccines was 58.9% [(95% Confidence Intervals): 57.5-60.3)] and 60.5% (59.1-61.9), respectively. These rates were reduced to 53.8% (51.2-55.0) and 50.8% (48.8-52.7) for the second dose. The most common local adverse effect reported for all vaccines was pain in the injection site. During the first week after the first dose of vaccines, the frequency of the pain for Sinopharm, AZD1222, Sputnik V, and Barekat was 35.5%, 86.0%, 77.6%, and 30.9%, respectively. The same rates after the second dose were 27.3%, 66.5%, 63.9%, and 49.0%. The most common systemic adverse effect was fatigue. In the first dose, it was 30.3% for Sinopharm, 67.4% for AZD1222, 47.6% for Sputnik V, and 17.1% for Barekat. These rates were reduced to 24.6%, 37.1%, 36.5%, and 19.5%, in the second dose of vaccines. AZD1222 had the highest local and systemic adverse effects rates. The odds ratio of local adverse effects of the AZD1222 vaccine compared to the Sinopharm vaccine were 8.73 (95% CI 6.93-10.99) in the first dose and 4.14 (95% CI 3.32-5.17) in the second dose. Barekat and Sinopharm had the lowest frequency of local and systemic adverse effects. Compared to Sinopharm, systemic adverse effects were lower after the first dose of Barekat (OR = 0.56; 95% CI 0.46-0.67). Reactogenicity events were higher in women and younger people. Prior COVID-19 infection increased the odds of adverse effects only after the first dose of vaccines. CONCLUSIONS: Pain and fatigue were the most common reactogenicities of COVID-19 vaccination. Reactogenicities were less common after the second dose of the vaccines. The adverse effects of AZD1222 were greater than those of other vaccines.

COVID-19 cases, hospitalizations and deaths after vaccination: a cohort event monitoring study, Islamic Republic of Iran.

Objective: To investigate the incidence of coronavirus disease 2019 (COVID-19) cases, hospitalizations and deaths in Iranians vaccinated with either AZD1222 Vaxzevria, CovIran® vaccine, SARS-CoV-2 Vaccine (Vero Cell), Inactivated (lnCoV) or Sputnik V. Methods: We enrolled individuals 18 years or older receiving their first COVID-19 vaccine dose between April 2021 and January 2022 in seven Iranian cities. Participants completed weekly follow-up surveys for 17 weeks (25 weeks for AZD1222) to report their COVID-19 status and hospitalization. We used Cox regression models to assess risk factors for contracting COVID-19, hospitalization and death. Findings: Of 89 783 participants enrolled, incidence rates per 1 000 000 person-days were: 528.2 (95% confidence interval, CI: 514.0-542.7) for contracting COVID-19; 55.8 (95% CI: 51.4-60.5) for hospitalization; and 4.1 (95% CI: 3.0-5.5) for death. Compared with SARS-CoV-2 Vaccine (Vero Cell), hazard ratios (HR) for contracting COVID-19 were: 0.70 (95% CI: 0.61-0.80) with AZD1222; 0.73 (95% CI: 0.62-0.86) with Sputnik V; and 0.73 (95% CI: 0.63-0.86) with CovIran®. For hospitalization and death, all vaccines provided similar protection 14 days after the second dose. History of COVID-19 protected against contracting COVID-19 again (HR: 0.76; 95% CI: 0.69-0.84). Diabetes and respiratory, cardiac and renal disease were associated with higher risks of contracting COVID-19 after vaccination. Conclusion: The rates of contracting COVID-19 after vaccination were relatively high. SARS-CoV-2 Vaccine (Vero Cell) provided lower protection against COVID-19 than other vaccines. People with comorbidities had higher risks of contracting COVID-19 and hospitalization and should be prioritized for preventive interventions.

Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran.

BACKGROUND: New vaccines that are initially approved in clinical trials are not completely free of risks. Systematic vaccine safety surveillance is required for ensuring safety of vaccines. This study aimed to provide a protocol for safety monitoring of COVID-19 vaccines, including Sputnik V, Sinopharm (BBIBP-CorV), COVIran Barekat, and AZD1222. METHODS: This is a prospective cohort study in accordance with a template provided by the World Health Organization. The target population includes citizens of seven cities in Iran who have received one of the available COVID-19 vaccines according to the national instruction on vaccination. The participants are followed for three months after they receive the second dose of the vaccine. For each type of vaccine, 30,000 people will be enrolled in the study of whom the first 1,000 participants are in the reactogenicity subgroup. The reactogenicity outcomes will be followed seven days after vaccination. Any hospitalization, COVID-19 disease, or other minor outcomes will be investigated in weekly follow-ups. The data are gathered through self-reporting of participants in a mobile application or phone calls to them. The study outcomes may be investigated for the third and fourth doses of vaccines. Other long-term outcomes may also be investigated after the expansion of the follow-up period. We have planned to complete data collection for the current objectives by the end 2022. DISCUSSION: The results of this study will be published in different articles. A live dashboard is also available for managers and policymakers. All data will be available on reasonable requests from the corresponding author.The use of the good and comprehensive guidelines provided by WHO, along with the accurate implementation of the protocol and continuous monitoring of the staff performance are the main strengths of this study which may be very useful for policymaking about COVID-19 vaccination.

Assessing the risk factors before pregnancy of preterm births in Iran: a population-based case-control study.

BACKGROUND: Preterm birth is a major cause of prenatal and postnatal mortality particularly in developing countries. This study investigated the maternal risk factors associated with the risk of preterm birth. METHODS: A population-based case-control study was conducted in several provinces of Iran on 2463 mothers referred to health care centers. Appropriate descriptive and analytical statistical methods were used to evaluate the association between maternal risk factors and the risk of preterm birth. All tests were two-sided, and P values < 0.05 were considered to be statistically significant. RESULTS: The mean gestational age was 31.5 ± 4.03 vs. 38.8 ± 1.06 weeks in the case and control groups, respectively. Multivariate regression analysis showed a statistically significant association between preterm birth and mother's age and ethnicity. Women of Balooch ethnicity and age ≥ 35 years were significantly more likely to develop preterm birth (OR: 1.64; 95% CI: 1.01--2.44 and OR: 9.72; 95% CI: 3.07-30.78, respectively). However, no statistically significant association was observed between preterm birth and mother's place of residence, level of education, past history of cesarean section, and BMI. CONCLUSION: Despite technological advances in the health care system, preterm birth still remains a major concern for health officials. Providing appropriate perinatal health care services as well as raising the awareness of pregnant women, especially for high-risk groups, can reduce the proportion of preventable preterm births.

The influence of occupational heat stress on serum inflammatory cytokines among traditional bakery workers in Iran.

Heat exposure exceeding the ISO7243:1989 standard limit can contribute to health problems among employees in a variety of workplaces. Ignoring heat standard requirements in hot working conditions such as bakeries results in physiologic and health problems, as well as an elevated risk of later illnesses. In this analytical case-control study, the serum levels of four inflammatory factors (interleukin-1 beta, interleukin-6, tumor necrosis factor-α, and C-reactive protein) were assessed using an enzyme-linked immunosorbent assay. 105 male artisan bakers (in four job classifications in bakeries and staff) were compared based on demographic characteristics and inflammatory factors. The findings of the study showed correlations between serum interleukin-1ß, interleukin-6, and C-reactive protein levels and thermal exposure in the occupational environment and employment type. Moreover, some differences in serum level of interleukin-1ß and job type were observed. Heat overexposure affected the increase of interleukin-1ß and C-reactive protein secretion. As a result of years of working in high-temperature conditions, inflammation can lead to subsequent diseases in workers. To protect their health from this occupational hazard, additional safeguards are needed. Our recommendations could also be applied to overly hot work environments that may cause heat stress in workers.

The first report of a known 4A syndrome patient with suspected manifestations of COVID-19, what was the final outcome?

The present study was performed on a 24-year-old Iranian man referred to Hospital with suspected symptoms of COVID-19, including fever, weakness, and cough. According to medical history, he had Alacrima, esophageal Achalasia, and adrenal insufficiency from childhood. Based on medical records and clinical examinations, the physician suspected 3A syndrome in the patient and requested further examination for MRI, CXR, and COVID-19 RT-PCR test. The result of the COVID-19 RT-PCR test was negative the next day. The patient's CXR showed ground-glass opacity (GGO) and pulmonary fibrosis. Based on images and MRI reports, severe posterior cortical atrophy disproportionate to chronological age and bilateral atrophy of the lacrimal gland were reported. After reviewing and summarizing the records, history, examinations, and Paraclinical tests, the patient was identified as a case of 4A syndrome.

Dose-dependent effects of oleuropein administration on regulatory T-cells in patients with rheumatoid arthritis: An in vitro approach.

INTRODUCTION: Rheumatoid arthritis (RA) is an autoimmune disease that is identified with chronic inflammation and progressive destruction of the joints. The defective activity of regulatory T cells (Tregs) plays a crucial role in RA development. Oleuropein (OLEU) is the most common polyphenolic compound in olive leaf extracts with numerous pharmacological activities. In this study, the potential effects of OLEU in shifting CD4+ T cells toward Tregs are evaluated in patients with RA. METHODS: 32 healthy controls (HC) and 45 RA patients were included in two groups. The immunoturbidometric technique was used to measure serum levels of c-reactive protein (CRP) and rheumatoid factor (RF). Isolated CD4+ T cells from peripheral blood mononuclear cells (PBMCs) of HC and RA patients were cultured with appropriate concentrations of OLEU. The cytotoxicity effects of OLEU were determined using the MTT assay at 24, 48, and 72 h. The percentage of CD4+CD25 + FoxP3 regulatory T lymphocytes (Tregs) and the expressions of IL-10 and TGF-ß were evaluated by flow cytometry and immunoassay techniques after treatment of cells with different concentrations of OLEU for 24 h. The serum levels of RF and CRP in patients with RA were 11.8 ± 5.32 IU/ml and 6.36 ± 5.82 mg/l, respectively. RESULTS: OLEU had a dose-dependent effect on the CD4+ T cells via increasing the frequency of CD4+CD25 + FoxP3 Tregs (p = 0.0001). Moreover, it induced the production of IL-10 (p = 0.0001) and TGF-ß (p < 0.01) in both HC and RA patients. CONCLUSION: The findings of this study suggest that OLEU may have immunomodulatory effects by inducing Tregs, and it might help in developing a novel nutrition strategy for management of autoimmune diseases such as RA.

Investigating the prevalence of hearing loss and its related factors in professional drivers in Shahroud city, Iran.

Objectives. A cohort study was designed and implemented to determine the prevalence of hearing problems and their related factors in professional drivers in Shahroud city. Methods. In total, 1461 professional drivers were examined. Demographic information, work history, blood parameters, and anthropometric and audiometric test data were collected. Hearing thresholds were assessed at frequencies of 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz. Results. In total, 64.8% and 54.9% of hearing impairment degrees were observed in the left and right ears, respectively, and this difference was statistically significant. The hearing threshold in the left ear was higher at all frequencies. The maximum hearing loss was at 6000 Hz, followed by 4000 Hz. There was a significant relationship between hearing loss with age groups for right and left ears and type of car for left ear. Conclusion. The prevalence and severity of hearing loss in Shahroud drivers are high, and most hearing loss is observed in the left ear. Given that noise-induced hearing loss is an incurable condition and has a significant impact on individuals' quality of life and employment, drivers should be regularly screened for ear damage under the variables affecting hearing loss, and noise prevention training should be provided.

The effect of spiritual care on quality of life of patients with amputation caused by diabetes type 2: a clinical trial.

OBJECTIVES: This study aimed to investigate effect of a spiritual care on quality of life of patients with amputation caused by diabetes type 2. METHODS: The current study was a clinical trial. Fifty four patients with amputation caused by diabetes type 2 referred to Al-Zahra hospital at Isfahan was allocated to two case and control groups. Spiritual care training including transcendental meditation (T.M) technique was established for case group. Participants in case group performed four weeks of meditation technique following participating in sessions of meditation technique training. Data gathering was done using a standard tool to assess quality of life in patients with diabetes (diabetes quality of life: DQOL). Data was analyzed using SPSS software. RESULTS: Mean score of quality of life in the four areas of quality of life was not significantly different among case and control groups at baseline, however, mean score of quality of life in case group (2.25 ± 0.56) was significantly better than control group (2.52 ± 0.38) after intervention (p<0.001). CONCLUSIONS: Given findings of the study, it seems that spiritual care can improve quality of life of patients with amputation caused by diabetes type 2.

Urbanization Levels and Its Association with Prevalence of Risk Factors and Colorectal Cancer Incidence.

BACKGROUND: Colorectal cancer is one of the most common cancers in the world. This study aimed to determine the relationship between risk factors and the incidence of colorectal cancer in Urbanization levels in Iran. METHODS: This was a population-based study. Urbanization levels were determined using the census data of the Statistical Center in 2012. Data on risk factors for colorectal cancer were obtained from the information provided by the Iranian Non-Communicable Disease Control Center and the incidence of colorectal cancer from the data from the National Cancer Registry System. Negative binomial regression analysis was used to determine the relationship between colorectal cancer risk factors and urbanization levels with colorectal cancer incidence. For statistical analysis, SPSS and Stata software were used. A significant level of P≤0.05 was considered. RESULTS: The relationship between urbanization levels and risk factors with the incidence of colorectal cancer, nutrition Status, tobacco use, and body mass index were not significant. There was a significant relationship between physical activity and incidence at different levels and between levels of urbanization and incidence rate, indicating a lower incidence rate of colorectal cancer at lower levels of urbanization. CONCLUSION: Colorectal cancer incidence is higher at higher levels of urbanization than lower levels. The difference between regions in terms of urbanization can have in flounce on access to facilities, health service, and counseling opportunities to modify the risk factors and access to proper screening and follow-up care.

Corrigendum to "Investigating the effect of meditation on spiritual wellbeing of Type-2 diabetic amputees: A clinical trial study" [Heliyon 6 (11) (November 2020) e05567].

[This corrects the article DOI: 10.1016/j.heliyon.2020.e05567.].

Investigating the effect of transcendental meditation on spiritual wellbeing of Type-2 diabetic amputees: A clinical trial study.

OBJECTIVES: Diabetes is a chronic, progressive and life-threatening metabolic syndrome that causes physical complications such as amputation, psychological complications and crisis in one's life, which leads to increased expression of spirituality and increased use of spiritual support as a coping mechanism. The aim of the present study was to investigate the effect of spiritual care on the spiritual wellbeing of type-2 diabetic amputees. MATERIALS AND METHODS: In the present clinical trial study, 54 type-2 diabetic amputees were randomly divided into two groups; namely, experimental and control in 2014 and underwent transcendental meditation (TM) in three sessions. The 20-item spiritual well-being scale (SWBS) (Paloutzian and Ellision), which measures the spiritual well-being dimensions, was completed by patients before and after the intervention. Data analysis was performed using descriptive and inferential methods (paired T-test, independent t-test, Fisher's exact test, mann-whitney test, and chi-square) in SPSS ver. 16. RESULTS: The results showed no statistically significant difference between the experimental and control groups in terms of mean spiritual wellbeing before the intervention, but, the post-intervention mean spiritual wellbeing score in the control and experimental groups was 97.82 ± 9.25 and 88.40 ± 9.47, respectively. (α = 0.05) (P = 0.001). CONCLUSION: According to the results of the present study, it seems that spiritual care is able to improve the spiritual wellbeing status of individuals.

More reliability of suspicious symptoms plus chest CT-scan than RT_PCR test for the diagnosis of COVID-19 in an 18-days-old neonate.

The present study investigated an 18-days-old neonate who was referred to the hospital with suspected respiratory symptoms of COVID-19. Results of CT-Scan and blood tests were highly suspicious, but result of the first RT-PCR test was negative on March 1. The second RT-PCR test reported positive on March 12. The neonate's medical history indicated no close contact except with family members and hospital treatment staffs, but the RT-PCR test results of all family members were also negative.

Risk of Stillbirth in Women with Gestational Diabetes and High Blood Pressure.

BACKGROUND: Both Gestational diabetes and hypertension almost affect 10.5% of the pregnancies. This study was conducted to investigate and compare the pregnancy outcomes in women with gestational diabetes or high blood pressure with outcomes belonging to healthy mothers. METHODS: This population-based case-control study was conducted in 8 provinces and two cities of Iran on women referred to the public health centers during 2015 to 2018. Descriptive statistics for variables presented by percentages and frequencies and logistic regression analysis was used to analyze data at a significance level of less than 0.05. RESULTS: Some variables such as ethnicity, maternal education and age, gestational diabetes, high blood pressure and previous pregnancy outcome were significantly associated with stillbirth. Maternal age greater than 35 yr (OR=1.78, CI: 1.29-2.48), maternal illiteracy (OR=3.67, CI: 2.25-5.98), a previous stillbirth (OR=9.92, CI: 4.98-19.78), gestational diabetes among women who had never had a screening test (OR =3.91, CI: 2.96-5.18) and high blood pressure (OR =1.95, CI: 1.38-2.77) were important factors associated with stillbirth. Maternal and paternal occupation, paternal education and age, place of residence, smoking and maternal BMI were significantly associated with stillbirth. CONCLUSION: Gestational diabetes, hypertension, a previous miscarriage, stillbirth, first pregnancy, low education level, advanced maternal age and ethnicity were associated with an increased risk of stillbirth. It is necessary to provide high-quality healthcare services before and during pregnancy particularly for those at heightened risk and improve knowledge of mothers on the side effects of each of the mentioned risk factors in order to control these factors more effectively and thus reducing the risk of stillbirth.

Determining the Levels of Urbanization in Iran Using Hierarchical Clustering.

BACKGROUND: In this study, we used a variety of factors that affect urbanization in Iran to evaluate different provinces in Iran in terms of the level of urbanization. METHODS: Using information from census 2011, we collected data on 33 indicators related to urbanization in 31 provinces in Iran. To rank the provinces we used density-based hierarchical clustering scheme. To determine similarities or differences between the provinces, the square of the Euclidean distance dissimilarity coefficient; Ward's algorithm was used to merge the provinces to minimize intra-cluster variance. One-way analysis of variance (ANOVA) was used to determine the variance between the variables used to rank the provinces in terms of different levels of urbanization. Statistical analysis was performed using SPSS. RESULTS: The provinces in Iran were combined with each other in 30 stages and classified into four levels. Taking into account the variables used to rank the level of urbanization, Tehran, and Alborz provinces were at the highest level of urbanization. On the other hand, the provinces of Sistan and Baluchistan, Kerman, North Khorasan, South Khorasan, Hormozgan, and Bushehr were at the lowest level of urbanization. CONCLUSION: Identification of provinces at the same level of urbanization can help us to discover the strengths and weaknesses in the infrastructures of each of them. Given the differences between various levels of urbanization, the identification of factors that are effective in the process of urbanization can help to access more information required for designing plans for the years to come.

In Memory of Dr. Mahmoud Bahmanyar, an International Researcher of the Pasteur Institute of Iran.

In Iran and also throughout the world, Dr. Mahmoud Bahmanyar (1919-2007) is acknowledged as a well-known researcher mainly in the field of rabies and plague. As an expert of plague for the World Health Organization (WHO), he accomplished many missions in several countries such as India, Cambodia, Myanmar, Indonesia, Vietnam, Yemen, and Brazil. His research on rabies has played an important role leading to the successful combined use of immune-serum and anti-rabies vaccine for prevention of human rabies worldwide. He also conducted many studies in the field of typhus, relapsing fever, and polio. The present article aimed to review his activities.