Detection of influenza virus in urban wastewater during the season 2022/2023 in Sicily, Italy.

Introduction: Seasonal influenza generally represents an underestimated public health problem with significant socioeconomic implications. Monitoring and detecting influenza epidemics are important tasks that require integrated strategies. Wastewater-based epidemiology (WBE) is an emerging field that uses wastewater data to monitor the spread of disease and assess the health of a community. It can represent an integrative surveillance tool for better understanding the epidemiology of influenza and prevention strategies in public health. Methods: We conducted a study that detected the presence of Influenza virus RNA using a wastewater-based approach. Samples were collected from five wastewater treatment plants in five different municipalities, serving a cumulative population of 555,673 Sicilian inhabitants in Italy. We used the RT-qPCR test to compare the combined weekly average of Influenza A and B viral RNA in wastewater samples with the average weekly incidence of Influenza-like illness (ILI) obtained from the Italian national Influenza surveillance system. We also compared the number of positive Influenza swabs with the viral RNA loads detected from wastewater. Our study investigated 189 wastewater samples. Results: Cumulative ILI cases substantially overlapped with the Influenza RNA load from wastewater samples. Influenza viral RNA trends in wastewater samples were similar to the rise of ILI cases in the population. Therefore, wastewater surveillance confirmed the co-circulation of Influenza A and B viruses during the season 2022/2023, with a similar trend to that reported for the weekly clinically confirmed cases. Conclusion: Wastewater-based epidemiology does not replace traditional epidemiological surveillance methods, such as laboratory testing of samples from infected individuals. However, it can be a valuable complement to obtaining additional information on the incidence of influenza in the population and preventing its spread.

Increased adherence to influenza vaccination among Palermo family pediatricians: a study on safety and compliance of qLAIV vaccination.

BACKGROUND: Influenza represents a serious public health threat, especially for the management of severe cases and complications of the disease, requiring the implementation of control measures. We aimed to assess the acceptance and impact of qLAIV vaccination among a representative sample of family paediatricians (FPs) operating in Palermo Local Health Authority (LHA). To this end we evaluated vaccination coverage rates, comparing it with that observed in Sicilian context, while actively monitoring possible adverse reactions and their severity. METHODS: An observational descriptive non-controlled study was conducted in two phases, from September 2022 to June 2023. The first phase involved a formative and educational intervention with a pre-intervention questionnaire to assess the knowledge and attitudes of FPs on paediatric influenza vaccination. The second phase consisted of an active surveillance on qLAIV safety and acceptance among the paediatric population assisted by the participating FPs, from October 2022 to April 2023. Frequencies, chi-squared tests, and comparisons statistics were performed using Stata/MP 14.1. RESULTS: The overall coverage rate among the paediatric population involved in the intervention was 13.2%, with an I.M./qLAIV ratio of vaccine administered of 1/4.25. This coverage rate was significantly higher (p-value <0.001) when compared to the average values reported in the population under the Palermo Local Health Authority (LHA) (6.7%) and in the entire Sicily (5.9%). Adverse events in the qLAIV group were mild, with only 3.3% experiencing them, primarily presenting as a feverish rise (3.2%). No severe adverse reaction was reported. CONCLUSIONS: The educational intervention significantly raised paediatric influenza vaccination rates among the participating FPs, and in general improved influenza vaccination coverage rates in the Palermo's LHU. Minimal, non-serious adverse events underscored the vaccine's safety. Training sessions ensured paediatricians stayed informed, enabling them to provide comprehensive information to parents for secure and informed vaccination decisions in their practices.

Factors Associated with Primary Liver Cancer Survival in a Southern Italian Setting in a Changing Epidemiological Scenario.

A retrospective observational study utilising cancer incidence data from a population-based registry investigated determinants affecting primary liver cancer survival in a southern Italian region with high hepatitis viral infection rates and obesity prevalence. Among 2687 patients diagnosed between 2006 and 2019 (65.3% male), a flexible hazard-based regression model revealed factors influencing 5-year survival rates. High deprivation levels [HR = 1.41 (95%CI = 1.15-1.76); p < 0.001], poor access to care [HR = 1.99 (95%IC = 1.70-2.35); p < 0.0001], age between 65 and 75 [HR = 1.48 (95%IC = 1.09-2.01); p < 0.05] or >75 [HR = 2.21 (95%CI = 1.62-3.01); p < 0.0001] and residing in non-urban areas [HR = 1.35 (95%CI = 1.08-1.69); p < 0.01] were associated with poorer survival estimates. While deprivation appeared to be a risk factor for primary liver cancer patients residing within the urban area, the geographic distance from specialised treatment centres emerged as a potential determinant of lower survival estimates for residents in the non-urban areas. After balancing the groups of easy and poor access to care using a propensity score approach, poor access to care and a lower socioeconomic status resulted in potentially having a negative impact on primary liver cancer survival, particularly among urban residents. We emphasise the need to interoperate cancer registries with other data sources and to deploy innovative digital solutions to improve cancer prevention.

Whole-Genome Sequencing and Genetic Diversity of Human Respiratory Syncytial Virus in Patients with Influenza-like Illness in Sicily (Italy) from 2017 to 2023.

Monitoring the genetic variability of human respiratory syncytial virus (hRSV) is of paramount importance, especially for the potential implication of key antigenic mutations on the emergence of immune escape variants. Thus, to describe the genetic diversity and evolutionary dynamics of hRSV circulating in Sicily (Italy), a total of 153 hRSV whole-genome sequences collected from 770 hRSV-positive subjects between 2017 and 2023, before the introduction of expanded immunization programs into the population, were investigated. The phylogenetic analyses indicated that the genotypes GA.2.3.5 (ON1) for hRSV-A and GB.5.0.5a (BA9) for hRSV-B co-circulated in our region. Amino acid (AA) substitutions in the surface and internal proteins were evaluated, including the F protein antigenic sites, as the major targets of immunoprophylactic monoclonal antibodies and vaccines. Overall, the proportion of AA changes ranged between 1.5% and 22.6% among hRSV-A, whereas hRSV-B varied in the range 0.8-16.9%; the latter was more polymorphic than hRSV-A within the key antigenic sites. No AA substitutions were found at site III of both subgroups. Although several non-synonymous mutations were found, none of the polymorphisms known to potentially affect the efficacy of current preventive measures were documented. These findings provide new insights into the global hRSV molecular epidemiology and highlight the importance of defining a baseline genomic picture to monitor for future changes that might be induced by the selective pressures of immunological preventive measures, which will soon become widely available.

Herpes zoster (HZ) vaccine coverage and confidence in Italy: a Nationwide cross-sectional study, the OBVIOUS project.

BACKGROUND: Herpes Zoster is an age dependent disease and as such it represents a problem in the Italian social context, where the demographic curve is characterized by an overrepresentation of the elderly population. Vaccines against Herpes Zoster are available, safe and effective, however coverage remains sub-optimal. This study was therefore conducted to examine the variations in Herpes Zoster vaccine uptake and confidence across different regions in Italy. METHODS: This study utilized a cross-sectional computer-assisted web interview (CAWI) methodology. The survey was conducted by Dynata, an online panel provider, and involved 10,000 respondents recruited in Italy between April 11 and May 29, 2022. The sample was stratified based on geographic region, gender, and age group. Data management adhered to European Union data protection regulations, and the survey covered demographics, living conditions, and vaccination against herpes zoster (HZ), following the BeSD framework. RESULTS: The findings indicate regional disparities in herpes zoster vaccine uptake across Italy. Notably, the Islands region exhibits a particularly low vaccination rate (2.9%), highlighting the need for targeted interventions. The multivariate regression analysis showed that sociodemographic factors, limited access to healthcare services, and inadequate awareness of vaccine eligibility contribute to the lower uptake observed in this region. CONCLUSION: In conclusion, this research emphasizes regional disparities in herpes zoster (HZ) vaccination uptake in Italy. Demographic, socioeconomic, and geographic factors impact individuals' willingness to receive the vaccine. The study highlights the importance of awareness of vaccine eligibility and accessible vaccination facilities in increasing uptake rates.

Non-Destructive and Non-Invasive Approaches for the Identification of Hydroxy Lead-Calcium Phosphate Solid Solutions ((PbxCa1-x)5(PO4)3OH) in Cultural Heritage Materials.

Lead-calcium phosphates are unusual compounds sometimes found in different kinds of cultural heritage objects. Structural and physicochemical properties of this family of materials, which fall into the hydroxypyromorphite-hydroxyapatite solid solution, or (PbxCa1-x)5(PO4)3OH, have received considerable attention during the last few decades for promising applications in different fields of environmental and material sciences, but their diagnostic implications in the cultural heritage context have been poorly explored. This paper aims to provide a clearer understanding of the relationship between compositional and structural properties of the peculiar series of (PbxCa1-x)5(PO4)3OH solid solutions and to determine key markers for their proper non-destructive and non-invasive identification in cultural heritage samples and objects. For this purpose, a systematic study of powders and paint mock-ups made up of commercial and in-house synthesized (PbxCa1-x)5(PO4)3OH compounds with a different Pb2+/Ca2+ ratio was carried out via a multi-technique approach based on scanning electron microscopy, synchrotron radiation-based X-ray techniques, i.e., X-ray powder diffraction and X-ray absorption near edge structure spectroscopy at the Ca K- and P K-edges, and vibrational spectroscopy methods, i.e., micro-Raman and Fourier transform infrared spectroscopy. The spectral modifications observed in the hydroxypyromorphite-hydroxyapatite solid solution series are discussed, by assessing the advantages and disadvantages of the proposed techniques and by providing reference data and optimized approaches for future non-destructive and non-invasive applications to study cultural heritage objects and samples.

Decade-long insights: tracking asbestos-related health impacts among formerly exposed workers in Palermo, Italy.

Background: Asbestos is a foremost occupational carcinogen globally. Despite the prohibition under Law 257/1992, Italy persists as one of the European nations most burdened by asbestos-related diseases (ARDs). This research assessed ARD cases in asbestos-exposed workers from the Province of Palermo, Italy, spanning 2010-2021. Methods: Data acquisition utilized the epidemiological dataset from the 'Service of Prevention and Safety on Work Environment' under the Prevention Department of Palermo's Local Health Authority (LHA). Results: Between 2010 and 2021, we identified 245 ARD instances, comprising 163 Asbestosis/Pleural plaques, 41 Lung Cancers, 38 Mesotheliomas, and 3 unspecified cases. Multivariate analysis indicated a notable decline in temporal exposure for mesothelioma (HR=0.933; 95% CI=0.902-0.965) and lung cancer (HR=0.93; 95% CI=0.90-0.978) relative to pleural plaques/asbestosis. Tobacco use displayed a pronounced correlation with lung cancer (smoker HR=64.520 95% CI=13,075-318.390; former smoker HR=20.917 95% CI=4,913-89.048). A significant link was observed between mesothelioma and pleural plaques/asbestosis in those employed in shipbuilding and repair (HR=0.371 95% CI=0.155-0.892). Conclusions: ARDs persist in clinical observations, even following the 1992 cessation of asbestos-related activities, emphasizing an enduring public health challenge. Enhancing prevention strategies is paramount, focusing on amplifying anamnestic and occupational data collection, thereby facilitating superior early diagnosis strategies for these maladies in the occupationally exposed cohort.

Exploring future perspectives and pipeline progression in vaccine research and development.

Introduction: The COVID-19 pandemic had a profound impact on vaccines' Research and Development, on vaccines' market, and on immunization programmes and policies. The need to promptly respond to the health emergency boostered resources' al-location and innovation, while new technologies were made available. Regulatory procedures were revised and expedited, and global production and distribution capacities significantly increased. Aim of this review is to outline the trajectory of research in vaccinology and vaccines' pipeline, highlighting major challenges and opportunities, and projecting future perspectives in vaccine preventables diseases' prevention and control. Study Design: Narrative review. Methods: We comprehensively consulted key biomedical databases including "Medline" and "Embase", preprint platforms, including"MedRxiv" and "BioRxiv", clinical trial registries, selected grey literature sources and scientific reports. Further data and insights were collected from experts in the field. We first reflect on the impact that the COVID-19 had on vaccines' Research and Development, regulatory frameworks, and market, we then present updated figures of vaccines pipeline, by different technologies, comparatively highlighting advantages and disadvantages. We conclude summarizing future perspectives in vaccines' development and immunizations strategies, outlining key challenges, knowledge gaps and opportunities for prevention strategies. Results: COVID-19 vaccines' development has been largely supported by public funding. New technologies and expetited autho-rization and distribution processes allowed to control the pandemic, leading vaccines' market to grow exponentially. In the post-pandemic era investments in prevention are projected to decrease but advancements in technology offer great potential to future immunization strategies. As of 2023, the vaccine pipeline include almost 1,000 candidates, at different Research and Development phase, including innovative recombinant protein vaccines, nucleic acid vaccines and viral vector vaccines. Vaccines' technology platforms development varies by disease. Overall, vaccinology is progressing towards increasingly safe and effective products that are easily manufacturable and swiftly convertible. Conclusions: Vaccine research is rapidly evolving, emerging technologies and new immunization models offer public health new tools and large potential to fight vaccines preventables diseases, with promising new platforms and broadened target populations. Real-life data analysis and operational research is needed to evaluate how such potential is exploited in public health practice to improve population health.

Real-life experience on COVID-19 and seasonal influenza vaccines co-administration in the vaccination hub of the University Hospital of Palermo, Italy.

With the pandemic, there has been a global reduction in influenza virus circulation, with WHO reporting, during 2021/22 season, laboratory testing positivity rate for influenza of less than 3%. Influenza surveillance systems anticipated a peak of influenza cases in the Northern Hemisphere during 2022/2023 season and the Italian Ministry of Health recommended the routinary co-administration of influenza with bivalent COVID-19 vaccines for the 2022/2023 season. At the Vaccination Hub of the University Hospital (UH) of Palermo, more than 700 subjects received influenza and COVID-19 booster doses in co-administration, during the 2021/2022 season. A cross-sectional study analyzing attitudes and factors associated with adherence to influenza and COVID-19 seasonal vaccines co-administration was conducted at the Vaccination Hub of the UH of Palermo, from October to December 2022. Among the 1,263 respondents, 74.7% (n = 944) received the co-administration of seasonal influenza and COVID-19 vaccines. The main reason reported for accepting it was confidence in the recommendations of the Health Ministry (41.3%). At the multivariable analysis, subjects aged ≤ 59 y old (AdjOR: 2.48; CIs95%: 1.89-3.65), male (AdjOR: 1.51; CIs95%: 1.27-1.75), Health-care professionals (HCPs) (AdjOR: 1.66; CIs95%: 1.08-2.57) and those who received co-administration during 2021/2022 (AdjOR: 41.6; CIs95%: 25.5-67.9) were significantly more prone to receive co-administration during 2022/23 season. From data obtained, the role of HCPs in accepting and then promoting co-administration of COVID-19 and influenza vaccines is crucial, as well as receiving co-administration in the previous season that represented the main drive for accepting it in the following seasons, supporting safety and effectiveness of this procedure.

Mid-Term Estimates of Influenza Vaccine Effectiveness against the A(H1N1)pdm09 Prevalent Circulating Subtype in the 2023/24 Season: Data from the Sicilian RespiVirNet Surveillance System.

The current influenza season started in Italy in October 2023, approaching the epidemic peak in late December (52nd week of the year). We aimed to explore the mid-term virologic surveillance data of the 2023/2024 influenza season (from 16 October 2023 to 7 January 2024) in Sicily, the fourth most populous Italian region. A test-negative design was used to estimate the effectiveness of seasonal influenza vaccine (VE) against A(H1N1)pdm09 virus, the predominant subtype in Sicily (96.2% of laboratory-confirmed influenza cases). Overall, 29.2% (n = 359/1230) of oropharyngeal swabs collected from patients with influenza-like illness (ILI) were positive for influenza. Among the laboratory-confirmed influenza cases, 12.5% (n = 45/359) were vaccinated against influenza, with higher prevalence of laboratory-confirmed diagnosis of influenza A among subjects vaccinated with quadrivalent inactivated standard dose (29.4%), live attenuated intranasal (25.1%), and quadrivalent inactivated high-dose (23.8%) influenza vaccines. Comparing influenza vaccination status for the 2023/2024 season among laboratory-confirmed influenza-positive and -negative samples, higher vaccination rates in influenza-negative samples (vs. positive) were observed in all age groups, except for 45-64 years old, regardless of sex and comorbidities. The overall adjusted VE (adj-VE) was 41.4% [95%CI: 10.5-61.6%], whereas the adj-VE was 37.9% [95%CI: -0.7-61.7%] among children 7 months-14 years old and 52.7% [95%CI: -38.0-83.8%] among the elderly (≥65 years old).

Enhancing routine immunization efforts for older adults and frail individuals: Good practices during the SARS-CoV-2 pandemic in Italy.

Infectious diseases pose a significant burden on the general population, particularly older adults who are more susceptible to severe complications. Immunization plays a crucial role in preventing infections and securing a healthier aging, but actual vaccination rates among older adults and frail individuals (OAFs) remains far from recommended targets. This study aims to collect and share good practices implemented in several Italian local health districts during the SARS-CoV-2 pandemic to ease routine immunization for OAFs. A 28-items questionnaire has been developed to collect information on organization aspect of immunization services and local good practices implemented before and during the SARS-CoV-2 pandemic. Twelve Public Health managers representative of 9 Italian Regions were further interviewed between January and March 2021. Despite literature suggests several effective interventions to increase vaccine demand, improve vaccine access, and enhance healthcare providers' performance, our survey highlighted substantial heterogeneity in their implementation at local level. Seven good local practices have been identified and described: mass vaccination centers; vaccination mobile units; drive-through vaccination; co-administration; tailored pathways; cooperation among providers involved in vaccination; digitization. Our survey pointed out valuable strategies for enhancing routine immunization for OAFs. Providers should combine effective interventions adequate to their specific context and share good practices.

Pneumococcal vaccine uptake among high-risk adults and children in Italy: results from the OBVIOUS project survey.

BACKGROUND: Streptococcus pneumoniae infections, including Invasive Pneumococcal Diseases (IPDs), pose a substantial public health challenge, causing significant morbidity and mortality, especially among children and older adults. Vaccination campaigns have played a vital role in reducing pneumococcal-related deaths. However, obstacles related to accessibility and awareness might impede optimal vaccine adoption. This study aims to provide comprehensive data on pneumococcal vaccine coverage and attitudes within at-risk groups in Italy, with the goal of informing public health strategies and addressing vaccination barriers. METHODS: Between April 11 and May 29, 2022, a questionnaire investigating vaccine uptake and attitudes toward several vaccinations was administered to 10,000 Italian adults, chosen through population-based sampling. Respondents who were targets of the campaign according to the 2017-2019 National Vaccination Plan, accessed questions regarding pneumococcal vaccination. Data on uptake, awareness of having the right to free vaccination, opinion on vaccine safety, concern with pneumococcal disease, and ease of access to vaccination services were summarized and presented based on statistical regions. Multinomial logistic regression analysis was used to explore factors influencing vaccine uptake. RESULTS: Out of 2357 eligible adult respondents (42.6% women; mean age: 58.1 ± 15.7), 39.5% received pneumococcal vaccination. Uptake differed among at-risk groups: respondents aged ≥65 (33.7%), with lung disease (48.4%), cardiovascular disease (46.6%), and diabetes (53.7%). Predictors of not being vaccinated and unwilling to included female gender, residing in rural areas, lower education, low concern about pneumococcal disease, vaccine safety concerns, and associations with vaccine-opposed acquaintances. Health access issues predicted willingness to be vaccinated despite non-vaccination. Pneumopathy, heart disease, diabetes, and living in Northeastern or Central Italy were linked to higher uptake. Among the 1064 parents of eligible children, uptake was 79.1%. Parental unawareness of children's free vaccination eligibility was a predictor of non-vaccination. Vaccine safety concerns correlated with reluctance to vaccinate children, while perceived healthcare access challenges were associated with wanting but not having received vaccination. CONCLUSIONS: Pneumococcal vaccination uptake within prioritized groups and children in Italy remains inadequate. Scarce awareness of vaccine availability and obstacles in accessing vaccinations emerge as principal barriers influencing this scenario.

Influenza Vaccine Uptake in Italy-The 2022-2023 Seasonal Influenza Vaccination Campaign in Italy: An Update from the OBVIOUS Project.

Influenza is a significant public health concern, with Italy being profoundly impacted annually. Despite extensive vaccination campaigns and cooperative initiatives between the Public Health Departments of Local Healthcare Authorities and family physicians, low vaccine uptake rates persist. This study builds upon the OBVIOUS project, providing an updated picture of influenza vaccine uptake in Italy through a representative sample. A cross-sectional computer-assisted web interviewing (CAWI) survey of 10,001 Italian citizens was conducted between 31 March and 5 June 2023. Our findings underscore the negative impact of a lack of awareness that a person is in a priority group for influenza vaccination (-26.1 percentage points in vaccine uptake) and the profound influence of social circles on vaccination decisions (-5 percentage points when unfavorable). Medical professionals played a pivotal role, with recommendations from family doctors significantly promoting vaccine uptake (+20.2 percentage points). Age, chronic conditions, and socio-demographic factors also influenced vaccination behaviors. For children, parental negative perceptions regarding the flu (-10.4 percentage points) and vaccine safety (-23.4 percentage points) were crucial determinants. The present study emphasizes the need for a comprehensive approach addressing awareness, societal beliefs, and tailored medical advice to enhance vaccination rates and protect public health in Italy.

Prevalence of smoking habits, attitudes and knowledge on counteractive strategies among a sample of healthcare employees: results of the smoking-free health environments project in the province of Palermo, Italy.

Introduction: Tobacco use is responsible for over 7 million deaths annually, making smoking the leading cause of preventable mortality globally. Over the last two decades in Italy, the prevalence of smoking among physicians has consistently decreased, while it remains higher and is gradually decreasing among non-physician healthcare workers. The aim of this study was to investigate the Prevalence of smoking habits, attitudes, and knowledge on counteractive strategies among employees in the Primary Healthcare Facilities in the Province of Palermo, Italy. Methods: A cross-sectional survey was conducted between June 2020 and December 2020 through a previously validated anonymous questionnaire structured in four sections including 34 items. Data were analyzed using Stata/MP 12.1 statistical software. Results: Overall, 2,645 participants answered the questionnaire. The prevalence of either current or former smokers was 18.6%. Based on the multivariable analysis conducted, a significantly higher frequency of current smokers was observed among male participants (AdjOR: 1.29; CI95%: 1.02-1.64) and those belonging to the Surgical Unit (AdjOR: 1.92; CI95%: 1.27-2.90). Conversely, the prevalence of current smokers was significantly lower among those with at least one child (AdjOR: 0.67; CI95%: 0.49-0.91), with an educational qualification equal to or greater than a graduation degree (AdjOR: 0.56; CI95%: 0.43-0.73), those who considered second-hand smoke harmful (AdjOR: 0.06; CI95%: 0.008-0.60), those who had observed smoking or detected the smell of smoke in their workplace (AdjOR: 0.64; CI95%: 0.45-0.91). Furthermore, the prevalence of current smokers was significantly lower among participants who believed that healthcare professionals could play a crucial role in influencing their patients' lifestyles (AdjOR: 0.67; CI95%: 0.50-0.90) and among those who recommend their patients to quit smoking (AdjOR: 0.35; CI95%: 0.24-0.51). Discussion: The results of the current research demonstrate that, despite the decline in smoking prevalence among physicians, the rate of smokers among healthcare facility employees remains unacceptably high. This underscores the need to re-evaluate current anti-tobacco strategies in the workplace.

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016).

DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Switching between HVs during the childhood vaccination series is sometimes necessary due to, for example, vaccine availability, health-care provider preference, and/or tender awards. The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. Healthy participants approximately 11-13 months of age who previously received a two-dose primary series of Hexyon® (HHV group) or Vaxelis® (VVV group) all received a Vaxelis® booster dose. Immunogenicity was evaluated by measuring antibody levels to individual vaccine antigens approximately 30 days following booster vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). The proportions of participants with antibody-specific responses for antigens contained in both Vaxelis® and Hexyon® at 30 days post-toddler-booster vaccination with Vaxelis® were comparable between groups, and higher in the VVV group for Vaxelis® antigens PRN and FIM2/3. The overall proportions of participants with AEs were generally comparable between groups. Following a booster dose of Vaxelis®, immune responses were comparable between groups for all shared antigens, and higher in the VVV group for antigens found only in Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens.

Human Papillomavirus (HPV) Vaccine Coverage and Confidence in Italy: A Nationwide Cross-Sectional Study, the OBVIOUS Project.

BACKGROUND: Human Papillomavirus (HPV) vaccination rates are still below the target due to vaccine refusal or delay, lack of knowledge, and logistical challenges. Understanding these barriers is crucial for developing strategies to improve HPV vaccination rates. METHODS: This cross-sectional study used a questionnaire to investigate social and behavioral factors influencing decision making about the HPV vaccine. The survey was conducted from 11 April to 29 May 2022 and involved 10,000 Italian citizens aged ≥ 18 years. The sample was stratified based on region of residence, gender, and age group. RESULTS: 3160 participants were surveyed about themselves, while 1266 respondents were surveyed about their children's vaccine uptake. Among females aged ≥ 26 years, the national average HPV vaccine uptake was 21.7%, with variations across different regions. In the 18-25 age group, females had a vaccine uptake (80.8%) twice as much as males (38.1%), while vaccine uptake among male and female children aged 9-11 was similar. CONCLUSIONS: The OBVIOUS study in Italy reveals factors influencing low HPV vaccine uptake, suggesting targeted approaches, tailored information campaigns, heightened awareness of eligibility, promoting early vaccination, addressing low-risk perception among males, addressing safety concerns, and enhancing perceived accessibility to improve vaccine uptake and mitigate health risks.

Implant replacement and anaplastic large cell lymphoma associated with breast implants: a quantitative analysis.

Introduction: Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare form of non-Hodgkin T-cell lymphoma associated with breast reconstruction post-mastectomy or cosmetic-additive mammoplasty. The increasing use of implants for cosmetic purposes is expected to lead to an increase in BIA-ALCL cases. This study investigated the main characteristics of the disease and the factors predicting BIA-ALCL onset in patients with and without an implant replacement. Methods: A quantitative analysis was performed by two independent researchers on cases extracted from 52 primary studies (case report, case series, and systematic review) published until April 2022 and searched in PubMed, Scopus, and Google-Scholar databases using "Breast-Implant" AND/OR "Associated" AND/OR "Anaplastic-Large-Cell-Lymphoma". The statistical significance was verified by Student's t-test for continuous variables, while Fisher's exact test was applied for qualitative variables. Cox model with time-dependent covariates was used to estimate BIA-ALCL's onset time. The Kaplan-Meier model allowed the estimation of the probability of survival after therapy according to breast implant exposure time. Results: Overall, 232 patients with BIA-ALCL were extracted. The mean age at diagnosis was 55 years old, with a mean time to disease onset from the first implant of 10.3 years. The hazard of developing BIA-ALCL in a shorter time resulted significantly higher for patients not having an implant replacement (hazard ratio = 0.03; 95%CI: 0.005-0.19; p-value < 0.01). Patients with implant replacement were significantly older than patients without previous replacement at diagnosis, having a median time to diagnosis since the first implant of 13 years (7 years in patients without replacement); anyway, the median time to BIA-ALCL occurrence since the last implantation was equal to 5 years. Discussion: Our findings suggest that, in BIA-ALCL patients, the implant substitution and/or capsulectomy may delay the disease's onset. However, the risk of reoccurrence in an earlier time should be considered in these patients. Moreover, the time to BIA-ALCL onset slightly increased with age. Selection bias, lack of awareness, misdiagnosis, and limited data availability could be identified as limits of our study. An implant replacement should be considered according to a risk stratification approach to delay the BIA-ALCL occurrence in asymptomatic patients, although a stricter follow-up after the implant substitution should be recommended. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO, identifier: CRD42023446726.

Tracking the Selective Pressure Profile and Gene Flow of SARS-CoV-2 Delta Variant in Italy from April to October 2021 and Frequencies of Key Mutations from Three Representative Italian Regions.

The SARS-CoV-2 Delta variant of concern (VOC) was often associated with serious clinical course of the COVID-19 disease. Herein, we investigated the selective pressure, gene flow and evaluation on the frequencies of mutations causing amino acid substitutions in the Delta variant in three Italian regions. A total of 1500 SARS-CoV-2 Delta genomes, collected in Italy from April to October 2021 were investigated, including a subset of 596 from three Italian regions. The selective pressure and the frequency of amino acid substitutions and the prediction of their possible impact on the stability of the proteins were investigated. Delta variant dataset, in this study, identified 68 sites under positive selection: 16 in the spike (23.5%), 11 in nsp2 (16.2%) and 10 in nsp12 (14.7%) genes. Three of the positive sites in the spike were located in the receptor-binding domain (RBD). In Delta genomes from the three regions, 6 changes were identified as very common (>83.7%), 4 as common (>64.0%), 21 at low frequency (2.1%-25.0%) and 29 rare (≤2.0%). The detection of positive selection on key mutations may represent a model to identify recurrent signature mutations of the virus.

Attitudes towards Vaccinations in a National Italian Cohort of Patients with Inflammatory Bowel Disease.

BACKGROUND: The vaccination status of patients with inflammatory bowel disease (IBD) should be investigated before starting any treatment, and patients should eventually be vaccinated against vaccine-preventable diseases (VPDs). Patients with IBD may have suboptimal vaccination rates. The aim of this study was to evaluate the vaccination coverage, attitude towards vaccinations, and determinants among an Italian cohort of patients with IBD. METHODS: AMICI, the Italian IBD patients' association, sent an anonymous web-based questionnaire in February 2021. Previous vaccination status and patients' attitudes towards vaccinations were recorded. We examined the factors influencing their attitudes using crude and adjusted odds ratios (adjORs) with 95% confidence intervals (CIs). RESULTS: Among the 4039 patients invited, 1252 patients (including 729 women, median age 47.7 [37-58]) completed the questionnaire, with a response rate of 25.3%. Respondents declared being vaccinated against tetanus (74.1%), flu (67.7%; last season), MMR (43.3%), HBV (37.1%), pneumococcus (29.1%), meningitis (20%), HAV (16%), VZV (15.3%), and HPV (7.6%). Complete vaccination history was not remembered by 20.7% of the patients. One thousand one hundred and twelve (88.8%) expressed a positive attitude towards vaccination, 91 (7.3%) were indifferent, and 49 (3.9%) reported being opposed to vaccinations. The belief of a possible return of VPDs with a decline in vaccination coverage rates was the factor most strongly related to a positive attitude towards vaccinations (adjOR 5.67, 95% CI 3.45-9.30, p-value < 0.001). CONCLUSIONS: A low vaccination rate against some VPDs was found among a national cohort of patients with IBD, despite a generally positive attitude towards vaccinations.

Stakeholders' Understanding of European Medicine Agency's COVID-19 Vaccine Information Materials in EU and Regional Contexts.

The COVID-19 pandemic posed challenges to communicating accurate information about vaccines because of the spread of misinformation. The European Medicines Agency (EMA) tried to reassure the public by communicating early on about the development and approval of COVID-19 vaccines. The EMA surveyed patients/consumers, healthcare professional organizations, and individual stakeholders, both at the EU level and in an Italian regional context. The objectives of the study were to see if the EMA's core information materials were informative and well-understood and which communication channels were preferred by the public. The main findings showed that individual patients/consumers generally prefer to obtain information about COVID-19 vaccines from the internet or mass media, while organizations and individual healthcare professionals prefer to obtain information from national and international health authorities. Both at EU and local levels, participants had a good understanding of the key messages from regulators and found the materials useful and relevant. However, some improvements were recommended to the visual, text, and dissemination formats, including publishing more information on safety and using a more public-friendly language. Also, it was recommended to maintain the EMA's approach of using media, stakeholder engagement, and web-based formats to communicate about COVID-19 vaccines. In conclusion, user-testing of proactive communication materials aimed to prebunk misinformation during a public health crisis helps to ensure that users understand the development and safety of novel vaccine technologies. This information can then be used as a basis for further evidence-based communication activities by regulators and public health bodies in an emergency context.