PastoCovac and PastoCovac Plus as protein subunit COVID-19 vaccines led to great humoral immune responses in BBIP-CorV immunized individuals.

The optimal booster vaccine schedule against COVID-19 is still being explored. The present study aimed at assessment of the immunogenicity and antibody persistency of inactivated-virus based vaccine, BBIP-CorV and protein-subunit based vaccines, PastoCovac/Plus through heterologous and homologous prime-boost vaccination. Totally, 214 individuals who were previously primed with BBIBP-CorV vaccines were divided into three arms on their choice as heterologous regimens BBIBP-CorV/PastoCovac (n = 68), BBIBP-CorV/PastoCovac Plus (n = 72) and homologous BBIBP-CorV (n = 74). PastoCovac booster recipients achieved the highest rate of anti-Spike IgG titer rise with a fourfold rise in 50% of the group. Anti-RBD IgG and neutralizing antibody mean rise and fold rise were almost similar between the PastoCovac and PastoCovac Plus booster receivers. The antibody durability results indicated that the generated antibodies were persistent until day 180 in all three groups. Nevertheless, a higher rate of antibody titer was seen in the heterologous regimen compared to BBIP-CorV group. Furthermore, no serious adverse event was recorded. The protein subunit-based booster led to a stronger humoral immune response in comparison with the BBIP-CorV booster receivers. Both the protein subunit boosters neutralized SARS-CoV-2 significantly more than BBIP-CorV. Notably, PastoCovac protein subunit-based vaccine could be successfully applied as a booster with convenient immunogenicity and safety profile.

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 Dynamic Effective Reproductive Number of COVID-19 during the Epidemic in Iran

Background: We aimed to determine the generation time, the best model for estimating reproduction number (R), and to estimate the basic reproduction number (R0) and effective reproduction number (Rt) for COVID-19 in Iran. Methods: We used the daily incidence cases of COVID-19, hospitalized due to a probable diagnosis of COVID-19 from 19 February 2020 to 17 November 2020 in Iran. Four models, including maximum likelihood (ML), exponential growth (EG), time-dependent (TD), sequential Bayesian (SB) were evaluated. The weekly reproduction number with a 95% confidence interval (CI) was calculated. Results: TD model shows the best fit compared to other models for estimating reproduction number in Iran. The R0 in Iran in the first week of the epidemic, leading up to 21 February 2020 was 7.19, 95% CI: 5.56, 9.00. The lowest value for the Rt was equal to 0.77 between 3 to 10 March 2020 and 4 to 11 December 2020. From 11 June 2020 up to13 August 2020, the Rt was more than one but after then to 24 September 2021 was less than one. Conclusion: TD model was the best fit for estimating the R in Iran. The worst situation of the epidemic in Iran was related to the weeks leading up to 26 February 2020 and 28 October 2020, and better status was related to the weeks leading up to 10 March 2020 and 11 December 2020.

A case report of ulceroglandular tularemia caused by Francisella tularensis subsp. Holarctica in Iran.

BACKGROUND: Tularemia is a zoonotic disease that has been reported in many countries of the Northern Hemisphere. However, in some countries, such as Iran, this disease has been neglected by the health care system, and it is under-reported. CASE PRESENTATION: Here we report an unusual case of ulceroglandular tularemia occurring in a 35-year-old woman who presented with a skin lesion of the left flank, inguinal lymphadenopathy, and an abdominal abscess. The serological and real-time PCR tests for tularemia were positive for this patient, and infection by Francisella tularensis subsp. holarctica was confirmed. CONCLUSIONS: It is necessary to implement various educational programs to increase the awareness of physicians with tularemia.

Corrigendum to 'How Iran responded to expanding need for laboratory services for COVID-19?'

[This corrects the article DOI: 10.1016/j.hlpt.2021.100506.].

A description of spatial-temporal patterns of the novel COVID-19 outbreak in the neighbourhoods' scale in Tehran, Iran.

Background: Analyzing and monitoring the spatial-temporal patterns of the new coronavirus disease (COVID-19) pandemic can assist local authorities and researchers in detecting disease outbreaks in the early stages. Because of different socioeconomic profiles in Tehran's areas, we will provide a clear picture of the pandemic distribution in Tehran's neighbourhoods during the first months of its spread from February to July 2020, employing a spatial-temporal analysis applying the geographical information system (GIS). Disease rates were estimated by location during the 5 months, and hot spots and cold spots were highlighted. Methods: This study was performed using the COVID-19 incident cases and deaths recorded in the Medical Care Monitoring Centre from February 20, to July 20, 2020. The local Getis-Ord Gi* method was applied to identify the hotspots where the infectious disease distribution had significantly clustered spatially. A statistical analysis for incidence and mortality rates and hot spots was conducted using ArcGIS 10.7 software. Results: The addresses of 43,000 Tehrani patients (15,514 confirmed COVID-19 cases and 27,486 diagnosed as probable cases) were changed in its Geo-codes in the GIS. The highest incidence rate from February to July 2020 was 48 per 10,000 and the highest 5-month incidence rate belonged to central and eastern neighbourhoods. According to the Cumulative Population density of patients, the higher number is estimated by more than 2500 people in the area; however, the lower number is highlighted by about 500 people in the neighborhood. Also, the results from the local Getis-Ord Gi* method indicate that COVID-19 has formed a hotspot in the eastern, southeast, and central districts in Tehran since February. We also observed a death rate hot spot in eastern areas. Conclusion: Because of the spread of COVID-19 disease throughout Tehran's neighborhoods with different socioeconomic status, it seems essential to pay attention to health behaviors to prevent the next waves of the disease. The findings suggest that disease distribution has formed a hot spot in Tehran's eastern and central regions.

Spatio-temporal patterns of the COVID-19 pandemic, and place-based influential factors at the neighborhood scale in Tehran.

Since its emergence in late 2019, the COVID-19 pandemic has attracted the attention of researchers in various fields, including urban planning and design. However, the spreading patterns of the disease in cities are still not clear. Historically, preventing and controlling pandemics in cities has always been challenging due to various factors such as higher population density, higher mobility of people, and higher contact frequency. To shed more light on the spread patterns of the pandemic, in this study we analyze 43,000 confirmed COVID-19 cases at the neighborhood level in Tehran, the capital of Iran. To examine spatio-temporal patterns and place-based factors contributing to the spread of the pandemic, we used exploratory spatial data analysis and spatial regression. We developed a geo-referenced database composed of 12 quantitative place-based variables related to physical attributes, land use and public transportation facilities, and demographic status. We also used the geographically weighted regression model for the local examination of spatial non-stationarity. According to the results, population density (R2 = 0.88) and distribution of neighborhood centers (R2 = 0.59), drugstores (R2 = 0.64), and chain stores (R2 = 0.59) are the main factors contributing to the spread of the disease. Additionally, density of public transportation facilities showed a varying degree of contribution. Overall, our findings suggest that demographic composition and major neighborhood-level physical attributes are important factors explaining high rates of infection and mortality. Results contribute to gaining a better understanding of the role of place-based attributes that may contribute to the spread of the pandemic and can inform actions aimed at achieving Sustainable Development Goals, particularly Goals 3 and 11.

How Iran responded to expanding need for laboratory services for COVID-19?

After the emergence of SARS-CoV-2 in early 2020 in Iran, the rapid response team of Pasteur Institute of Iran was the first lab starting detection and report of suspected human samples. This article is a short summery of all actions from the preparedness for detecting the first cases of COVID-19, expanding the nationwide laboratory service, choosing the suitable laboratory tests and other challenges in laboratory detection during SARS-CoV-2 pandemic in Iran.

Iran COVID-19 Epidemiology Committee: A Review of Missions, Structures, Achievements, and Challenges.

BACKGROUND: Since the beginning of the coronavirus disease 2019 (COVID-19) epidemic in Iran, the control and management of the epidemic were headed by the National Headquarter for the Control of COVID-19 Epidemic through setting up different scientific committees, including the COVID-19 National Epidemiology Committee. The present study reviews the missions, structures, achievements, and challenges of the Epidemiology Committee. STUDY DESIGN: A rapid review . METHODS: All relevant reports, documents, guidelines, published literature, and surveillance data related to the establishment, visions, missions, roles, activities, and outputs of the COVID-19 Epidemiology Committee were critically reviewed in this study. RESULTS: The efforts of the committee's working groups may have impacted improvements in data registration/usage, provincial data quality at provincial levels, and perception of the epidemic situation in the provinces. The committees have also played role in informing the policies in different stages of the epidemic through routine or problem-based data/evidence analyses, epidemic investigations, and mathematical modeling. CONCLUSION: The structure and experience gained by the committee can be used in similar situations within and outside the country. To further improve the impacts of our activities, it is essential to have effective interaction, collaboration, and data flow between the committee and a broad range of organizations within and outside the Ministry of Health and Medical Education.

Prolonged viral shedding and antibody persistence in patients with COVID-19.

SARS-CoV-2 as a new global threat has affected global population for one year. Despite the great effort to eradicate this infection, there are still some challenges including different viral presentation, temporal immunity in infected individuals and variable data of viral shedding. We studied 255 COVID-19 suspected individuals to assess the viral shedding duration and also the antibody development against SARS-CoV-2 among the cases. Real Time RT-PCR assay was applied to determine the virus presence and SARS-CoV-2 antibodies were evaluated using SARS-CoV-2 IgM and IgG kits. 113 patients were confirmed for COVID-19 infection. The patients were followed until negative PCR achieved. The median viral shedding among studied population was obtained 34.16 (±17.65) days which was not significantly associated with age, sex and underlying diseases. Shiver and body pain were found in prolonged form of the infection and also patients who had gastrointestinal problems experienced longer viral shedding. Moreover, IgG was present in 84% of patients after 150 days. According to this data, the median viral shedding prolongation was 34.16 days which indicates that 14 days isolation might not be enough for population. In addition, IgG profiling indicated that it is persistent in a majority of patients for nearly 6 months which has brought some hopes in vaccine efficacy and application.

The Urgency of Conducting Serological Studies for COVID-19.

BACKGROUND: COVID-19 has been the most priority of the world since the early 2020s. We aimed to investigate the importance, urgency and value of serological tests for monitoring and evaluation of COVID-19. STUDY DESIGN: Rapid review. METHODS: This study was conducted through a review of seroepidemiological studies to evaluate their strength and weakness in monitoring and predicting the epidemic situation of COVID-19. RESULTS: Conducting serological studies is an important measure to determine the status of the COVID-19 in affected countries. These studies may also be used to estimate cumulative incidence of the disease, and to get an impression about the level of the epidemic. CONCLUSION: If an accurate serological test is available it can be used for seroepidemiological studies and epidemic investigation in special context, but given the current situation, it may not be possible to be used for screening the normal population and in care and treatment. This research highlighted the importance and urgency of conducting serological studies for monitoring the COVID-19 situation and evaluation of the interventions.

How Can the Epidemic Curve of COVID-19 in Iran Be Interpreted?

BACKGROUND: Iran is one of the countries most affected by COVID-19. This review provides possible interpretations of the observed trend of COVID-19 in Iran. STUDY DESIGN: A rapid review METHODS: We reviewed the daily new cases of COVID-19 based on hospitalized and outpatients, reported deaths, and diagnostic testing in Iran. RESULTS: Iran reported its first peak in the number of cases in late March, 2020. From the 1 April to 3 May 2020, the downward trend in the number of cases was started. The death trend also showed a peak in early April as well as a downward trend in late April. During May, the number of death cases showed a stable trend with a daily number of deaths ranging between 50 and 75 cases. Then the number of deaths gradually increased. CONCLUSION: The epidemic curve in Iran is a function of different factors such number of total tests, change in mitigation policies, and heterogeneities among different provinces in the country. Therefore it should be interpreted under the light of the effect of such factors.

Zoonotic implications of camel diseases in Iran.

Approximately 60% of all human pathogens and 75% of emerging infectious diseases are zoonotic (of animal origin). Camel zoonotic diseases can be encountered in all camel-rearing countries. In this article, all studies carried out on camel zoonotic diseases in Iran are reviewed to show the importance of camels for public health in this country. More than 900 published documents were systematically searched to find relevant studies from 1,890 until late 2018. The collected articles were classified according to the aetiological agents. In this study, 19 important zoonotic diseases were reported among Iranian camels including listeriosis, leptospirosis, plague, Q fever, brucellosis, campylobacteriosis, tuberculosis, pasteurellosis, clostridiosis, salmonellosis, Escherichia coli infections, rabies, camelpox, Middle East respiratory syndrome coronavirus, Crimean-Congo haemorrhagic fever, echinococcosis, cryptosporidiosis, toxoplasmosis and dermatophytosis, most of which belong to bacterial, viral, parasitic and fungal pathogens, respectively. Results show that camels are one of the most important sources of infections and diseases in human; therefore, continuous monitoring and inspection programs are necessary to prevent the outbreak of zoonotic diseases caused by this animal in humans.

Estimating COVID-19-Related Infections, Deaths, and Hospitalizations in Iran Under Different Physical Distancing and Isolation Scenarios

BACKGROUND: Iran is one of the first few countries that was hit hard with the coronavirus disease 2019 (COVID-19) pandemic. We aimed to estimate the total number of COVID-19 related infections, deaths, and hospitalizations in Iran under different physical distancing and isolation scenarios. METHODS: We developed a susceptible-exposed-infected/infectious-recovered/removed (SEIR) model, parameterized to the COVID-19 pandemic in Iran. We used the model to quantify the magnitude of the outbreak in Iran and assess the effectiveness of isolation and physical distancing under five different scenarios (A: 0% isolation, through E: 40% isolation of all infected cases). We used Monte-Carlo simulation to calculate the 95% uncertainty intervals (UIs). RESULTS: Under scenario A, we estimated 5 196 000 (UI 1 753 000-10 220 000) infections to happen till mid-June with 966 000 (UI 467 800-1 702 000) hospitalizations and 111 000 (UI 53 400-200 000) deaths. Successful implantation of scenario E would reduce the number of infections by 90% (ie, 550 000) and change the epidemic peak from 66 000 on June 9, to 9400 on March 1, 2020. Scenario E also reduces the hospitalizations by 92% (ie, 74 500), and deaths by 93% (ie, 7800). CONCLUSION: With no approved vaccination or therapy available, we found physical distancing and isolation that include public awareness and case-finding and isolation of 40% of infected people could reduce the burden of COVID-19 in Iran by 90% by mid-June.