Clinical characteristics and outcomes of vaccinated patients hospitalised with SARS-CoV-2 breakthrough infection: Multi-IPV, a multicentre study in Northern Italy

Background: Despite the well-known efficacy of anti-COVID-19 vaccines in preventing morbidity and mortality, several vaccinated individuals are diagnosed with SARS-CoV-2 breakthrough infection, which might require hospitalisation. This multicentre, observational, and retrospective study aimed to investigate the clinical characteristics and outcomes of vaccinated vs. non -vaccinated patients, both hospitalised with SARS-CoV-2 infection in 3 major hospitals in Northern Italy. Methods: Data collection was retrospective, and paper and electronic medical records of adult patients with a diagnosed SARS-CoV-2 infection were pseudo-anonymised and analysed. Vaccinated and non -vaccinated individuals were manually paired, using a predetermined matching criterion (similar age, gender, and date of hospitalisation). Demographic, clinical, treatment, and outcome data were compared between groups differing by vaccination status using Pearson's Chi-square and Mann -Whitney tests. Moreover, multiple logistic regression analyses were performed to assess the impact of vaccination status on ICU admission or intra-hospital mortality. Results: Data from 360 patients were collected. Vaccinated patients presented with a higher prevalence of relevant comorbidities, like kidney replacement therapy or haematological malignancy, despite a milder clinical presentation at the first evaluation. Non -vaccinated patients required intensive care more often than their vaccinated counterparts (8.8% vs. 1.7%, p = 0.002). Contrariwise, no difference in intra-hospital mortality was observed between the two groups (19% vs. 20%, p = 0.853). These results were confirmed by multivariable logistic regressions, which showed that vaccination was significantly associated with decreased risk of ICU admission (aOR=0.172, 95%CI: 0.039-0.542, p = 0.007), but not of intra-hospital mortality (aOR=0.996, 95%CI: 0.582-1.703, p = 0.987). Conclusions: This study provides real -world data on vaccinated patients hospitalised with COVID-19 in Northern Italy. Our results suggest that COVID-19 vaccination has a protective role in individuals with higher risk profiles, especially regarding the need for ICU admission. These findings contribute to our understanding of SARS-CoV-2 infection outcomes among vaccinated individuals and emphasise the importance of vaccination in preventing severe disease, particularly in those countries with lower first -booster uptake rates. (c) 2024 The Author(s). Published by Elsevier Ltd on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Clinical characteristics and outcomes of vaccinated patients hospitalised with SARS-CoV-2 breakthrough infection: Multi-IPV, a multicentre study in Northern Italy

Background: Despite the well-known efficacy of anti-COVID-19 vaccines in preventing morbidity and mortality, several vaccinated individuals are diagnosed with SARS-CoV-2 breakthrough infection, which might require hospitalisation. This multicentre, observational, and retrospective study aimed to investigate the clinical characteristics and outcomes of vaccinated vs. non -vaccinated patients, both hospitalised with SARS-CoV-2 infection in 3 major hospitals in Northern Italy. Methods: Data collection was retrospective, and paper and electronic medical records of adult patients with a diagnosed SARS-CoV-2 infection were pseudo-anonymised and analysed. Vaccinated and non -vaccinated individuals were manually paired, using a predetermined matching criterion (similar age, gender, and date of hospitalisation). Demographic, clinical, treatment, and outcome data were compared between groups differing by vaccination status using Pearson's Chi-square and Mann -Whitney tests. Moreover, multiple logistic regression analyses were performed to assess the impact of vaccination status on ICU admission or intra-hospital mortality. Results: Data from 360 patients were collected. Vaccinated patients presented with a higher prevalence of relevant comorbidities, like kidney replacement therapy or haematological malignancy, despite a milder clinical presentation at the first evaluation. Non -vaccinated patients required intensive care more often than their vaccinated counterparts (8.8% vs. 1.7%, p = 0.002). Contrariwise, no difference in intra-hospital mortality was observed between the two groups (19% vs. 20%, p = 0.853). These results were confirmed by multivariable logistic regressions, which showed that vaccination was significantly associated with decreased risk of ICU admission (aOR=0.172, 95%CI: 0.039-0.542, p = 0.007), but not of intra-hospital mortality (aOR=0.996, 95%CI: 0.582-1.703, p = 0.987). Conclusions: This study provides real -world data on vaccinated patients hospitalised with COVID-19 in Northern Italy. Our results suggest that COVID-19 vaccination has a protective role in individuals with higher risk profiles, especially regarding the need for ICU admission. These findings contribute to our understanding of SARS-CoV-2 infection outcomes among vaccinated individuals and emphasise the importance of vaccination in preventing severe disease, particularly in those countries with lower first -booster uptake rates

Hybrid versus vaccine immunity of mRNA-1273 among people living with HIV in East and Southern Africa: a prospective cohort analysis from the multicentre CoVPN 3008 (Ubuntu) study.

BACKGROUND: With limited access to mRNA COVID-19 vaccines in lower income countries, and people living with HIV (PLWH) largely excluded from clinical trials, Part A of the multicentre CoVPN 3008 (Ubuntu) study aimed to assess the safety of mRNA-1273, the relative effectiveness of hybrid versus vaccine immunity, and SARS-CoV-2 viral persistence among PLWH in East and Southern Africa during the omicron outbreak. METHODS: Previously unvaccinated adults with HIV and/or other comorbidities associated with severe COVID-19 received either one (hybrid immunity) or two (vaccine immunity) 100-mcg doses of ancestral strain mRNA-1273 in the first month, depending on baseline evidence of prior SARS-CoV-2 infection. In a prospective cohort study design, we used covariate-adjusted Cox regression and counterfactual cumulative incidence methods to determine the hazard ratio and relative risk of COVID-19 and severe COVID-19 with hybrid versus vaccine immunity within six months. The ongoing Ubuntu study is registered on ClinicalTrials.gov (NCT05168813) and this work was conducted from December 2021 to March 2023. FINDINGS: Between December 2021 and September 2022, 14,237 participants enrolled, and 14,002 (83% PLWH, 69% SARS-CoV-2 seropositive) were included in the analyses. Vaccinations were safe and well tolerated. Common adverse events were pain or tenderness at the injection site (26.7%), headache (20.4%), and malaise (20.3%). Severe adverse events were rare (0.8% of participants after the first and 1.1% after the second vaccination), and none were life-threatening or fatal. Among PLWH, the median CD4 count was 635 cells/μl and 18.5% had HIV viraemia. The six-month cumulative incidences in the hybrid immunity and vaccine immunity groups were 2.02% (95% confidence interval [CI] 1.61-2.44) and 3.40% (95% CI 2.30-4.49) for COVID-19, and 0.048% (95% CI 0.00-0.10) and 0.32% (95% CI 0.59-0.63) for severe COVID-19. Among all PLWH the hybrid immunity group had a 42% lower hazard rate of COVID-19 (hazard ratio [HR] 0.58; 95% CI 0.44-0.77; p < 0.001) and a 73% lower hazard rate of severe COVID-19 (HR 0.27; 95% CI 0.07-1.04; p = 0.056) than the vaccine immunity group, but this effect was not seen among PLWH with CD4 counts <350 cells/μl or HIV viraemia. Twenty PLWH had persistent SARS-CoV-2 virus at least 50 days. INTERPRETATION: Hybrid immunity was associated with superior protection from COVID-19 compared to vaccine immunity with the ancestral mRNA-1273 vaccine. Persistent infections among immunocompromised PLWH may provide reservoirs for emerging variants. FUNDING: National Institute of Allergy and Infectious Diseases

4 - Two-Year Efficacy and Safety of Rezūm Water Vapor Thermal Therapy in Large Prostates (≥80 mL)

Hypothesis / aims of study: While initial guidelines recommended Rezūm for prostates less than 80 mL, recent studies have demonstrated its efficacy and safety in larger prostates. Water Vapor Thermal Therapy (WVTT), Rezūm, is a minimally invasive therapy that uses water vapor to ablate benign prostatic tissue. This study aims to present the prospective, multi-center outcomes of the largest cohort of prostates ≥80 mL treated with Rezūm. Study design, materials and methods: This study involved a prospective, Rezum registry which collated information from two high-volume centers between April 2019 and August 2024. Baseline medical histories, uroflowmetry (Qmax, PVR), and validated questionnaires (IPSS, IPSS QoL, BPHII, IIEF-15, MSHQ-EjD) were recorded. The main outcomes assessed included symptom scores, functional improvement, and safety at baseline, 6, 12 and 24 months. Results: A total of 259 patients with a prostate volume ≥80 mL were treated with Rezūm. The median prostate volume was 105 mL (interquartile range 91–122.5 mL), with 207 patients (81.2%) exhibiting a median lobe. A history of urinary retention was noted in 86 patients (33.6%). On average, 13.2 injections (±3.8) were administered per procedure, which lasted an average of 6.9 minutes (±10.1). The IPSS improved from 21.8 (n=212) at baseline to 9.1 at 6 months (n=131), 6.6 at 12 months (n=107), and 5.7 at 24 months (n=68). At baseline, the maximum urinary flow rate (Qmax) was 8.2 mL/s (n=198), increasing to 14.6 mL/s at 6 months (n=45), 14.1 mL/s at 12 months (n=46), and 14.9 mL/s at 24 months (n=33). Post-void residual (PVR) volume at baseline was 132.5 mL (n=196), decreasing to 72 mL at 6 months (n=42), 60 mL at 12 months (n=93), and 90 mL at 24 months (n=38). The IPSS quality of life (IPSS QoL) score decreased from 4.5 (n=212) at baseline to 1.4 at 6 months (n=131), 1.65 at 12 months (n=107), and 1.1 at 24 months (n=68). The BPHII decreased from 7.5 at baseline (n=171) to 3.3 at 6 months (n=86), 2.9 at 12 months (n=65), and 2.3 at 24 months (n=35). There was no significant difference noted in sexual function as measured by IIEF and MSHQ. Interpretation of results: Rezūm water vapor therapy appears to be both effective and well-tolerated in men with significantly enlarged prostates (≥80 mL), including those with challenging anatomy such as a median lobe and those with a history of urinary retention. Symptom improvement was both rapid and sustained over time. The International Prostate Symptom Score (IPSS) improved from a baseline of 21.8 to 5.7 at 24 months. Maximum urinary flow rate (Qmax) also improved significantly, rising from 8.2 mL/s at baseline to 14.9 mL/s at 24 months. Similarly, post-void residual volume (PVR) decreased from 132.5 mL at baseline to 90 mL at 24 months. Quality of life, as assessed by the IPSS QoL score, also improved dramatically The BPH Impact Index (BPHII) followed a similar trend, decreasing from 7.5 to 2.3 by 24 months. Importantly, sexual function was preserved, with no significant changes observed in IIEF or MSHQ scores. Concluding message: These findings suggest that Rezūm is a promising minimally invasive treatment option even for patients with large prostates and complex anatomy, offering durable symptom relief without compromising sexual health. Significant improvements were observed in urinary symptoms and quality of life, with minimal impact on sexual function.Funding no funding Clinical Trial No Subjects Human Helsinki Yes Informed Consent Ye

2 - Rezūm Therapy: Long-Term Outcomes at 3 Years in Patients with Enlarged Prostates

Hypothesis / aims of study: Rezūm therapy is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that utilizes water vapor thermal ablation. This study evaluates the three-year outcomes of Rezūm therapy, focusing on the durability of symptom relief and improvements in lower urinary tract symptoms (LUTS). This study aimed to evaluate the long-term outcomes of Rezūm therapy by assessing the durability of symptom relief and improvements in lower urinary tract symptoms (LUTS) over a three-year follow-up period. Study design, materials and methods: A prospective registry was established for Rezūm therapy at two international high-volume centers. We reviewed data for patients followed between April 2019 and October 2021. All patients had baseline medical and BPH history documented along with uroflowmetry (Qmax and PVR), and validated questionnaires (IPSS, IPSS QoL, BPHII, IIEF-15, MSHQ-EjD function and bother). Results: In this study, we evaluated 712 patients with a one-year follow-up, analyzing LUTS and sexual function. The mean age at treatment was 67.2 years (SD 8.9) with mean baseline prostate volume was 74.1 cc (SD 34.4). Patient follow-up data for post-void residual (PVR) volumes showed a decline from a baseline mean of 134.9 ml (n=598) to 47.8 ml at 24 months (n=145), and 38.5 ml at 36 months (n=18). Qmax demonstrated improvement, increasing from a baseline mean of 8.6 ml/s (n=584) to 15 ml/s at 24 months (n=103), and 12.1 ml/s at 36 months (n=17). The IPSS showed a notable decrease, with baseline scores averaging 22 (n=627), then dropping to 9.8 at 36 months (n=64). The IPSSQoL score improved from a baseline mean of 4.5 (n=627) to 1.9 at 36 months (n=64). BPHII improved from a baseline mean of 7.7 (n=489) to 2.9 at 12 months (n=210), 2.2 at 24 months (n=105), and 2.7 at 36 months (n=51). No statistically significant differences were observed in the IIEF or the MSHQ-EjD function and bother domains. Interpretation of results: The Rezūm procedure resulted in significant improvements with sustained benefits over three years. Concluding message: These findings underscore the treatment's effectiveness in enhancing patient well-being while maintaining stable sexual function.Funding No funding Clinical Trial Yes Public Registry No RCT No Subjects Human Helsinki Yes Informed Consent Ye

The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients.

Symptomatic burden in myeloproliferative neoplasms is present in most patients and compromises quality of life. We sought to validate a broadly applicable 18-item instrument (Myeloproliferative Neoplasm Symptom Assessment Form [MPN-SAF], coadministered with the Brief Fatigue Inventory) to assess symptoms of myelofibrosis, essential thrombocythemia, and polycythemia vera among prospective cohorts in the United States, Sweden, and Italy. A total of 402 MPN-SAF surveys were administered (English [25%], Italian [46%], and Swedish [28%]) in 161 patients with essential thrombocythemia, 145 patients with polycythemia vera, and 96 patients with myelofibrosis. Responses among the 3 administered languages showed great consistency after controlling for MPN subtype. Strong correlations existed between individual items and key symptomatic elements represented on both the MPN-SAF and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Enrolling physicians' blinded opinion of patient symptoms (6 symptoms assessed) were highly correlated with corresponding patients' responses. Serial administration of the English MPN-SAF among 53 patients showed that most MPN-SAF items are well correlated (r > 0.5, P 0.7). The MPN-SAF is a comprehensive and reliable instrument that is available in multiple languages to evaluate symptoms associated with all types of MPNs in clinical trials globally