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.

Long-Term Persistence of Anti-SARS-COV-2 IgG Antibodies.

Antibodies against severe acute respiratory syndrome coronavirus-2 (Anti-SARS-COV-2) can be detected in patients with COVID-19 in 7 to 10 days post onset of symptoms (POS). However, there is no firm evidence of the long-term persistence of these antibodies in recovered COVID-19 patients. Therefore, this study aimed to evaluate the stability of anti-SARS-COV-2 IgG in recovered COVID-19 patients in a 15-month follow-up testing. Thirty hospitalized patients with real-time PCR-confirmed SARS-COV-2 infections were included in the study and five serum samples (1st, 2nd, 3rd, 4th, and 5th) were collected from each participant. The serum levels of N and S specific anti-SARS-COV-2 IgG and IgM antibodies were evaluated by the immunoassay technique at the same time. To determine the correlation between levels of anti-SARS-CoV-2 IgG/IgM with severity of disease, neutrophil-to-lymphocyte ratio (NLR %), and the serum levels of C-reactive protein were evaluated using an automated analyzer and turbidimetry assays, respectively. The mean serum level of anti-SARS-CoV-2 IgG antibody was at the highest level up to 90 days and then decreased significantly 1 year POS (P < 0.0001). However, it was still detectable in a 15-month follow-up testing. There were no significant differences in the mean levels of IgG antibody in patients with mild, moderate, and severe diseases. The results from this study suggest that the titer of anti-SARS-COV-2 IgG antibody is detectable at high levels up to 3 months and then decreases over time. However, these antibodies can be reliably detected in up to 15 months, and they may persist for a long time.

COVID-19 re-infection in Shahroud, Iran: a follow-up study.

Although many people became infected and recovered during the COVID-19 epidemic, the immunity duration and re-infection in recovered patients have recently attracted many researchers. The aim of this study was to evaluate the recurrence of the infection in recovered individuals over a 9-month period after the onset of the COVID-19 epidemic. In this study, data related to COVID-19 patients in Shahroud city were collected using the electronic system for registering suspicious patients and also by checking patients' hospital records. In this study, from 20 March 2020 to 20 November 2020 (9 months), a total of 8734 suspected patients with respiratory symptoms were observed and followed up. RT-PCR was positive for 4039 patients. During this period, out of the total number of positive cases of COVID-19, 10 cases became re-infected after complete recovery. The risk of re-infection was 2.5 per thousand (0.95 CI 1.2-4.5). The mean time interval between the first infection and re-infection was 134.4 ± 64.5 days (range 41-234 days). The risk of re-infection between male and females was not statistically different (1.98 per 1000 women and 2.96 per 1000 men). Exposure to COVID-19 may not establish long-term protective immunity to all patients and may predispose them to re-infection. This fact can be reminded that the use of masks, social distancing and other preventive measures are very important in recovered patients and should be emphasised especially in health care personnel who are more exposed to the virus.

Effect of transcutaneous electrical nerve stimulation of acupoints on respiratory outcomes of COVID-19 patients with moderate pulmonary involvement: A parallel randomized clinical trial.

Background and aims: Experiencing respiratory symptoms, especially dyspnea and decreased oxygen saturation (SpO2) level in patients with coronavirus disease 2019 (COVID-19) is associated with increased mortality. The present study was conducted to investigate the effect of transcutaneous electrical nerve stimulation of acupoints (Acu-TENS) on the respiratory outcomes of COVID-19 patients with moderate pulmonary involvement. Methods: In these three-blind parallel randomized clinical trials, 84 patients with COVID-19 admitted to a referral hospital were selected by the convenience sampling method. Participants were randomly assigned to Acu-TENS (n = 42) and control (n = 42) groups. The Acu-TENS group received Acu-TENS over the EX-B1 (Dingchuan) acupuncture point for 45 min for four consecutive days, while participants in the control group received no intervention. Participants' respiratory outcomes, including oxygen saturation, vital signs, and the severity of dyspnea, were evaluated before and after each intervention on four consecutive days. In addition, the need for mechanical ventilation on Days 4, 8, and 12 and the disease's outcome (death or survival) were recorded in SPSS software version 16, and finally, data were analyzed using an independent samples t-test. Results: SpO2, the number of patients without the need for mechanical ventilation, and patient survival after the intervention were significantly higher in the Acu-TENS group compared with the control group (<0.001). However, respiratory rate, heart rate, and the severity of dyspnea after the intervention were not significantly different between the two groups (p > 0.05). Conclusion: The use of Acu-TENS could improve SpO2 as a respiratory outcome of patients with COVID-19 with moderate pulmonary involvement and it can be used as a therapeutic intervention.

Epidemiological patterns of syndromic symptoms in suspected patients with COVID-19 in Iran: A Latent Class Analysis.

BACKGROUND: Early diagnosis and supportive treatments are essential to patients with coronavirus disease 2019 (COVID-19). Therefore, the current study aimed to determine different patterns of syndromic symptoms and sensitivity and specificity of each of them in the diagnosis of COVID-19 in suspected patients. STUDY DESIGN: Cross-sectional study . METHODS: In this study, the retrospective data of 1,539 patients suspected of COVID-19 were obtained from a local registry under the supervision of the officials at Shahroud University of Medical Sciences, Shahroud, Iran. A Latent Class Analysis (LCA) was carried out on syndromic symptoms, and the associations of some risk factors and latent subclasses were accessed using one-way analysis of variance and Chi-square test. RESULTS: The LCA indicated that there were three distinct subclasses of syndromic symptoms among the COVID-19 suspected patients. The age, former smoking status, and body mass index were associated with the categorization of individuals into different subclasses. In addition, the sensitivity and specificity of class 2 (labeled as "High probability of polymerase chain reaction [PCR]+") in the diagnosis of COVID-19 were 67.43% and 76.17%, respectively. Furthermore, the sensitivity and specificity of class 3 (labeled as "Moderate probability of PCR+") in the diagnosis of COVID-19 were 75.92% and 50.23%, respectively. CONCLUSION: The findings of the present study showed that syndromic symptoms, such as dry cough, dyspnea, myalgia, fatigue, and anorexia, might be helpful in the diagnosis of suspected COVID-19 patients.

Serotyping of Klebsiella pneumoniae and Its Relation with Capsule-Associated Virulence Genes, Antimicrobial Resistance Pattern, and Clinical Infections: A Descriptive Study in Medical Practice.

OBJECTIVE: Klebsiella pneumoniae, one of the clinical superbugs, causes diverse infections because of its variable capsular antigens. This study focused on K. pneumoniae and aimed to assess any correlation between capsular serotype, capsule-associated virulence genes, and evaluate its resistance to conventional antibiotics in order to gain insight into any regional differences. MATERIALS AND METHODS: A total of 61 K. pneumoniae collected from various clinical specimens were confirmed genotypically. Clinical and demographic data for all patients were reviewed. All isolates were subjected to antimicrobial susceptibility tests. Capsular serotyping and capsule-associated virulence genes were studied using the molecular method. RESULTS: All typeable isolates were typed into K5, K20, and K54 serotypes, and among them, K54 was observed to be predominant. The most common capsule-associated virulence genes comprised uge (93.4%), ycfM (91.8%), and wabG (88.5%), while wcaG (29.5%) and rmpA (21.3%) were noted at much lower prevalence rates. The gene wcaG was significantly associated with K54 positive isolates (p = 0.001), while rmpA was associated with K20 positive isolates (p = 0.01). CONCLUSION: Serotype K54 had a high frequency in isolates collected from patients with pulmonary diseases, while serotype K20 was associated with burn patients. Carbapenems and levofloxacin were the best therapeutic options for the treatment of infections with serotypes K20 and K54.

Virulence characterization of Klebsiella pneumoniae and its relation with ESBL and AmpC beta-lactamase associated resistance.

BACKGROUND AND OBJECTIVES: Trend analysis reveals that Klebsiella pneumoniae has witnessed a steep enhancement in the antibiotic resistance and virulence over the last few decades. The present investigation aimed at a comprehensive approach investigating antibiotic susceptibility including, extended spectrum beta-lactamase (ESBL) and AmpC ß-lactamase (AmpC) resistance and the prevalence of virulence genes among the K. pneumoniae isolates. MATERIALS AND METHODS: Sixty-one K. pneumoniae isolates were obtained from various clinical infections. Antimicrobial susceptibility was performed by disk diffusion method. The Mast® D68C test detected the presence of ESBLs and AmpCs phenotypically, and later presence of ESBL and AmpC genes was observed by polymerase chain reaction (PCR). Multiplex-PCR was performed to investigate various virulence genes. RESULTS: Amongst 61 K. pneumoniae isolates, 59% were observed as ESBL and 14.7% as AmpC producers. All ESBL producers were positive for bla CTX-M-15 , while bla CTX-M-14 was observed in 54.1% isolates. The frequency of AmpC genes was as follows: bla CMY-2 (60.7%) and bla DHA-1 (34.4%). The most frequent virulence genes were those encoding enterobactin and lipopolysaccharide. Presence of mrkD was associated with bla DHA-1 gene, while bla CMY-2 significantly (p≤0.05) correlated with the presence of iutA and rmpA virulence genes. bla DHA-1 positive isolates had urine as a significant source, while bla CMY-2 positive isolates were mainly collected from wound exudates (p≤0.05). CONCLUSION: Our results highlight that ESBL and AmpC production along with a plethora of virulence trait on K. pneumoniae should be adequately considered to assess its pathogenesis and antibiotic resistance.