Project description:ObjectivesThe capability of the SARS-CoV-2 Omicron variant to escape immunity conferred by mRNA vaccines has led to the development of Omicron-adapted vaccines. In this study, we aimed to compare the immune response with the ancestral strain and with the BA.1 Omicron variant after administration of the original vaccine and the Omicron-adapted vaccine.MethodsThis is an ongoing phase 3, double-blinded randomized controlled trial, comparing the original BNT161b2 vaccine, monovalent Omicron BA.1-adapted BNT161b2 vaccine, and bivalent combinations. Each vaccine was given at a 30 μg and 60 μg dose. Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers for Omicron BA.5, and the incidence of COVID-19 cases.ResultsOverall, 122 individuals (22, 19, 20, 20, 20, 20, and 21 in each arm) completed a 90-day follow-up. Three months after vaccination, adjusting for baseline levels, neutralizing antibody titers were 0.63 (95% CI: 0.3-1.32) and 0.54 (0.24-1.2) for monovalent/60 μg, 0.9 (0.42-1.92) and 2.69 (1.17-6.17) times for monovalent-Omi.BA.1/30 μg, 1.28 (0.6-2.75) and 2.79 (1.21-6.41) times for monovalent-Omi.BA.1/60 μg, 0.96 (0.46-1.97) and 2.07 (0.93-4.58) times for bivalent-Omi.BA.1/30 μg, and 0.79 (0.38-1.63) and 1.95 (0.88-4.32) times for bivalent-Omi.BA.1/60 μg when compared with BNT162b2/30 μg against the ancestral strain and BA.1 variant, respectively.DiscussionBA.1-adapted mRNA vaccines lead to a stronger neutralizing antibody response against the Omicron BA.1 sub-variant.
Project description:Very few studies have been conducted to assess the potential preventive role of vaccines, particularly mRNA vaccines, in the improvement of survival among moderate and severe hospitalized patients with COVID-19. After community-acquired outbreaks of the Omicron variant from 18 March until 31 May 2022, occurred in Taiwan, this retrospective cohort of 4090 moderate and 1378 severe patients admitted to hospital was classified according to whether they were administered an mRNA-based vaccine, and followed up to ascertain rates of death in both the vaccinated (≥2 doses) and unvaccinated (no or 1 dose) groups. The age-adjusted hazard ratio (aHR) of less than 1 was used to assess the preventive role of mRNA vaccines in reducing deaths among moderate and severe Omicron-infected patients. Survival was statistically significantly better for the ≥2 dose jab group (aHR, 0.75, 95% confidence interval [CI], 0.60 to 0.94) and even higher among those who had received a booster jab (aHR, 0.71; 95% CI, 0.55 to 0.91) compared with the unvaccinated group among moderate patients, but not among severe patients. In conclusion, unveiling the role of mRNA vaccines in preventing moderate but not severe COVID-19 patients from death provides new insights into how mRNA vaccines play a role in the pathway leading to a severe outcome due to Omicron COVID-19.
Project description:ObjectiveTo investigate mammography facilities' follow-up times, population vulnerability, system-based processes, and association with cancer stage at diagnosis.Data sourcesProspectively collected from San Francisco Mammography Registry (SFMR) 2005-2011, California Cancer Registry 2005-2012, SFMR facility survey 2012.Study designWe examined time to biopsy for 17 750 abnormal mammogram results (BI-RADS 4/5), categorizing eight facilities as short or long follow-up based on proportion of mammograms with biopsy at 30 days. We examined facility population vulnerability (race/ethnicity, language, education), and system processes. Among women with a cancer diagnosis, we modeled odds of advanced-stage (≥IIb) cancer diagnosis by facility follow-up group.Data extraction methodsMerged SFMR, Cancer Registry and facility survey data.Principal findingsFacilities (N = 4) with short follow-up completed biopsies by 30 days for 82% of mammograms compared with 62% for facilities with long follow-up (N = 4) (P < 0.0001). All facilities serving high proportions of vulnerable women were long follow-up facilities. The long follow-up facilities had fewer radiologists, longer biopsy appointment wait times, and less communication directly with women. Having the index abnormal mammogram at a long follow-up facility was associated with higher adjusted odds of advanced-stage cancer (OR 1.45; 95% CI 1.10-1.91).ConclusionsProviding mammography facilities serving vulnerable women with appropriate resources may decrease disparities in abnormal mammogram follow-up and cancer diagnosis stage.
Project description:Background: Pediatric systemic lupus erythematosus (pSLE) is a rare condition, representing approximately 10% of SLE cases. The aim of this study was to identify variables to improve the diagnostic awareness and management of pSLE patients. Methods: This retrospective study included 25 patients diagnosed with pSLE and followed at the University of Pisa. We collected data about clinical profile at disease onset and during a long-term follow-up, including disease activity, organ damage development, and treatments received. Results: The mean patient age at disease onset was 14.6 ± 1.6 years, and the mean follow-up period was 14.17 ± 8.04 years. The most common initial manifestations were arthritis, malar rash, and cytopenias. The median time to diagnosis since the first symptoms was 6 months, and was significantly longer in patients with hematological onset (54 months). During follow-up, the number of patients with renal involvement showed a significant increase, from 36% at diagnosis to 72.2% after 10 years of disease evolution. Patients who developed chronic organ damage maintained a higher time-averaged disease activity during follow-up and received a significantly higher dose of corticosteroids. Conclusion: Patients with immune cytopenia represent a group deserving strict clinical follow-up for the risk of evolution to SLE. Intense surveillance of renal function, early treatment and steroid-sparing strategies should be strongly considered in the management of pSLE patients.
Project description:ObjectivesTo ascertain clinical sequelae, client satisfaction and sexual behavior 2+ years after male circumcision using the ShangRing device.MethodsWe enrolled 199 men from the Kenya sites (Homa Bay district) participating in a 2012 study of the ShangRing device used in routine male circumcision services (N = 552). We enrolled men who had had the ShangRing placed successfully, and over-sampled men who had had an adverse event and/or were HIV-positive during the field study. In the present study, each participant was examined and interviewed by a study clinician, and penile photographs were taken to document longer-term cosmetic results and any abnormal findings.Results194 men were included in the analysis. The mean and median times between circumcision and the longer-term follow-up visit in this study were 31.8 and 32 months, respectively. Four men (2.1%) had signs/symptoms of a sexually transmitted infection (STI). Virtually all (99.5%) of the men were very satisfied with the appearance of their circumcised penis, and all would recommend a ShangRing circumcision to friends or family members. The most prevalent reported advantage of the circumcision was the ease of bathing and enhanced cleanliness of the penis (75.8%). 94.3% of the men did not cite a single negative feature of their circumcision. 87.5% of men reported more sexual pleasure post-MC, the most common reason being more prolonged intercourse. The majority of men (52.6%) reported one sexual partner post-MC, but more than a quarter of the men (28.1%) reported an increased number of partners post-MC. Less than half of the men (44.3%) reported using condoms half of the time or more, but the great majority of condom users stated that condom use was much easier post-MC, and 76.9% of users said they used condoms more after circumcision than before.ConclusionsThis study supports the safety and acceptability of ShangRing male circumcision during 2-3 years of follow-up. It should allay worries that the ShangRing procedure could lead to delayed complications later than the observation period of most clinical studies.Trial registrationClinicalTrials.gov NCT01567436.