Search Results (76)

Background/Objectives: Meningococcal disease is primarily caused by serogroups A, B, C, W, and Y. Current US vaccination recommendations include routine serogroup A/C/W/Y (MenACWY) vaccination (ages 11–12 and 16 years) and a two-dose, 0-, 6-month MenB vaccination series (age 16–23 years) based on shared clinical decision-making. Administration of the first-in-class Pfizer pentavalent MenABCWY vaccine (Penbraya^TM), which received US licensure in 2023 as a two-dose, 0-, 6-month series, is endorsed when the MenACWY and MenB vaccines are recommended at the same visit. This study evaluated the immunogenicity and safety of two extended two-dose schedules of MenABCWY in healthy adolescents. Methods: In this observer-blinded, phase 2b study (ClinicalTrials.gov, NCT04440176; 19 June 2020), 309 healthy 11- to 14-year-olds were randomized 1:1 to receive a 0-, 36-month or 0-, 12-month Pfizer MenABCWY schedule, which more closely aligns with current US MenACWY vaccination recommendations. Endpoints included serum bactericidal assay using human complement seroprotection rates (titers ≥ 1:8 or ≥1:16, depending on strain), seroresponse rates (≥4-fold increase from baseline titer), and geometric mean titers (GMTs). Safety was also assessed. Results: One month after the second Pfizer MenABCWY dose, serogroup A/B/C/W/Y seroprotection rates were 100% for the 0-, 36-month schedule and 96.6–100% for the 0-, 12-month schedule; seroresponse rates were 100% and 92.9–100%, respectively. GMTs generally trended higher with the 0-, 36-month schedule. Seroprotection rates through 24 months after the second dose of the 0-, 12-month schedule were 44.0–75.0% for serogroup B and 88.9–100% for serogroup A/C/W/Y). No safety issues were identified. Conclusions: These data support Pfizer MenABCWY dosing flexibility and utility within the current or possible future US meningococcal vaccination framework. Full article

Background/Objectives: This study evaluated the Omicron LP.8.1 variant-adapted BNT162b2 mRNA vaccine (LP.8.1-adapted BNT162b2). Methods: This analysis is part of an ongoing phase 3 open-label study evaluating the immunogenicity, safety, and tolerability of LP.8.1-adapted BNT162b2. Reported here are descriptive 2-week post-vaccination results in 18–64 -year-olds at high risk of severe COVID-19 and in ≥65-year-olds who received the Omicron KP.2-adapted COVID-19 vaccine ≥ 6 months previously. Primary immunogenicity endpoints included neutralizing antibody geometric mean titers (GMTs) against LP.8.1 and KP.2 at 2 weeks after vaccination and geometric mean fold rises from baseline to 2 weeks after vaccination. Results were compared with a historical control group of adults who received KP.2-adapted BNT162b2 in a previous study. Tolerability and safety were also assessed. Results: Overall, 104 participants received LP.8.1-adapted BNT162b2 (18–64-year-olds, n = 51; ≥65-year-olds, n = 53). Baseline neutralizing GMTs were higher in LP.8.1-adapted BNT162b2 recipients than in the historical control group of KP.2-adapted BNT162b2 recipients against both sublineages (248 vs. 157 against LP.8.1; 372 vs. 187 against KP.2). Serum-neutralizing LP.8.1 and KP.2 GMTs increased 2 weeks after vaccination with LP.8.1-adapted BNT162b2 (1752 against LP.8.1; 2104 against KP.2) and historical control groups (1555 and 2395, respectively), and across both age groups. Reactogenicity events with LP.8.1-adapted BNT162b2 were generally mild or moderate and occurred at generally similar frequencies in both age groups. Adverse events were reported in 4.8% of participants (all in 18–64-year-olds); no serious adverse events were reported. Conclusions: After 2 weeks of follow-up, and in a small sample size, LP.8.1-adapted BNT162b2 was immunogenic in ≥65-year-olds and ≥18-year-olds at high risk of severe COVID-19. The safety and tolerability profile for LP.8.1-adapted BNT162b2 was consistent with the current US prescribing information for BNT162b2 and that of other variant-adapted BNT162b2 vaccines (Clinicaltrials.gov Identifier: NCT07069309, registered 16 July 2025). Full article

Professional experience placements are a requirement for undergraduate nursing students enabling real world skill development. Barriers to meaningful and positive placements have previously been reported, however there is limited research on how the location of placement impacts the student experience and outcomes. This study investigates the placement experiences of undergraduate nursing students at the University of Tasmania (UTAS) over a five-year period, with a focus on urban versus rural settings and year-level differences. Findings reveal that over one-third of students reported constructive placement experiences, with rural placements yielding slightly more positive outcomes than urban ones. First-year students were more likely to report constructive experiences compared to their senior counterparts, suggesting that longer placement durations may contribute to increased dissatisfaction. Quality of placement—defined by supervision and skill development—emerged as the most influential factor in shaping student experiences. While most students praised the quality of supervision, third-year students expressed both the highest praise and criticism. Opportunities for clinical and interpersonal skill development were central to students’ perceptions of placement quality, with rural placements slightly outperforming urban in skill development. However, some students, particularly in later years, felt that certain venues lacked adequate opportunities for skill acquisition. The study underscores the importance of high-quality supervision and appropriate clinical settings in enhancing placement experiences and suggests that constructive placements are more conducive to learning. These insights can inform strategies to improve the educational value of nursing placements across diverse settings. Full article

Background/Objectives: We aimed to determine safe and immunogenic RSVpreF vaccine dose levels for further clinical development in 2–<18 year olds. Methods: The phase 1, age-descending, open-label Picasso trial evaluated different RSVpreF dose levels in respiratory syncytial virus (RSV)-seropositive 2–<5 year olds and 5–<18 year olds who were either healthy or had chronic medical conditions with increased RSV illness risk. Participants received a single dose of RSVpreF (60 µg or 120 µg dose level). The primary objective was to describe safety and tolerability at each dose level and age group, including frequencies of reactogenicity and adverse events (AEs). The secondary objective was to describe RSV neutralizing antibody responses at each dose level and age group 1 month after vaccination. Results: Overall, 127 participants received RSVpreF 60 µg (2–<5 year olds, n = 20; 5–<18 year olds, n = 35) or 120 µg (n = 24 and n = 48, respectively); 54% were male and 69% were White. Local reactions and systemic events were reported in 17–20% and 33–45% of 2–<5 year olds, respectively, and 49–56% and 52–60% of 5–<18 year olds; most were mild or moderate in severity. AEs were reported in 13–15% of 2–<5 year olds and 8–14% of 5–<18 year olds. No AEs leading to withdrawal or vaccine-related serious AEs were reported. RSV-A and RSV-B neutralizing titer geometric mean fold rises from before to 1 month after vaccination with RSVpreF 60 and 120 µg, which were 17.7–20.6 and 42.8–39.8, respectively, in 2–<5 year olds, and 19.0–23.5 and 20.3–20.3, respectively, in 5–<18 year olds. Conclusions: RSVpreF was safe, well tolerated, and elicited immune responses in RSV-seropositive 2–<18-year-old participants, supporting further clinical development in this pediatric population, including those with chronic conditions. Full article

There is sustained research interest examining what constitutes positive and effective professional experience placements. However, few studies have investigated the financial costs of placements for health profession students. This study bridges the research gap by analysing the financial impacts of placements reported by nursing students in 2018/2019. The study analyses feedback from nursing students at the University of Tasmania, using a comparative lens analysing the costs for urban and rural placements (in this paper the term ‘rural’ includes regional, rural, remote and very remote). The results indicate students undertaking rural placements in Tasmania may be better supported than students with urban placements. This finding may be a result of the package of support provided by UTAS for its pre-registration nursing students when undertaking placements in rural locations. Full article

One of the greatest quests in physics in current times is the search for a grand unified theory—to bring all the forces of nature into one coherent explanatory framework. Despite two centuries of progress, both in comprehending the individual forces and formulating mathematical constructs to explain the existence and operation of such forces, the final step to unify the localised atomic and subatomic forces with gravity has proven to be elusive. Whilst recognising that there are arguments for and against the unification of all the forces of nature, the pursuit for unity has been driving many physicists and mathematicians to explore increasingly extraordinary ideas, from string theory to various other options requiring multiple dimensions. Can process philosophy ride to the rescue? By changing our perspective, it might be possible to derive a provocative and compelling alternative way to understand basic (and advanced) physics. This process approach would see all matter objects, at whatever scale, as energetic systems (inherently dynamic). Through the use of game theory, there is a way to appreciate the combination of entropy together with all the apparent forces of nature, being gravity and the more localised forces, within a singular, metaphysically consistent, construct. The outcome, however, challenges our whole understanding of the universe and fundamentally changes our relationship with matter. Full article

Gene therapies that induce the body to produce therapeutic anti-vascular endothelial growth factor (anti-VEGF) proteins are an emerging topic related to neovascular age-related macular degeneration (nAMD). Continuous delivery of anti-VEGF protein directly to the target tissue offers the possibility of lifelong efficacy without the need for repeated and frequent eye injections. This novel approach could revolutionize patient management through optimizing clinical outcomes while simplifying service delivery. However, such gene therapies are anticipated to face unique challenges related to patients’ access and health technology assessment (HTA), and their integration into real-world eyecare practices. This article presents key elements raised at the European Access Academy (EAA) Fall convention (held in Rome in October 2024) regarding anticipated HTA challenges for gene therapies in nAMD. The important role of HTA and policymakers in ensuring that emerging gene therapies are accessible to all eligible patients is also highlighted. This article mainly focuses on the need for a fit-for-purpose EU HTA framework to address the widely varying utilization of standard of care in nAMD clinical practice, and to incorporate considerations about the long-term durability of gene therapies in nAMD. The importance of integrating real-world evidence (RWE) into the EU HTA framework is also discussed. Full article

Background/objectives: This was a post hoc analysis of safety data across the bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine clinical trial development program. Methods: Data from eight clinical trials in 46,913 immunocompetent adults who received RSVpreF or placebo were analyzed. Local reactions and systemic events were assessed among non-pregnant ≥18-year-olds (n = 9517); adverse events (AEs) among pregnant and non-pregnant 18–59-year-olds (n = 9238); and vaccine-related AEs among non-pregnant ≥18-year-olds (n = 39,314). Post-marketing data in non-pregnant adults were considered. Results: Local reactions and systemic events were reported more frequently in RSVpreF versus placebo recipients; injection site pain was the most common local reaction (RSVpreF, 18.9%; placebo, 7.4%), and fatigue (23.5%; 18.4%) and headache (19.5%; 15.0%) were the most common systemic events. Percentages of AEs within 1 month after vaccination were similar across groups (RSVpreF, 12.8%; placebo, 13.1%); severe AEs were reported in ≤1.5% of participants. Differences in percentages of individuals reporting vaccine-related AEs between the RSVpreF and placebo groups were <0.2% for all related AEs. Serious AEs throughout the study were reported in ≤14.0% (RSVpreF, 12.6%; placebo, 14.0%). No atrial fibrillation, Guillain-Barré syndrome, or acute polyneuropathy cases were reported. The AE data from post-marketing data sources were consistent with the safety profile from the clinical trial program, with no new safety concerns. Conclusions: Integrated data demonstrated that RSVpreF was well tolerated with a favorable safety profile in non-pregnant and pregnant adults. Ongoing surveillance through real-world use and clinical trial experience continue to support the safety profile of RSVpreF. ClinicalTrials.gov: NCT03529773/NCT04071158/NCT04785612/NCT05035212/NCT05096208/NCT05842967/NCT04032093/NCT04424316. Full article

Background/Objectives: Diabetes mellitus has physical, psychological and behavioral implications related to glycemic control and quality of life. Our aims were to evaluate glycemic control and disease-related quality of life among adults with type 1 diabetes mellitus and to study their relationships with sociodemographic, clinical and anthropometric characteristics. Methods: Eighty-five participants (49.4% females, mean age 36 years, mean BMI 25.3 kg/m²) attending endocrinology and/or nutrition consultations at ULS São João (Porto, Portugal) were assessed regarding quality of life (Diabetes Health Profile) and social desirability (Marlowe–Crowne’s scale). Anthropometric (weight and height), biochemical (A1c) and metabolic control data (time at glycemic target) were collected, as well as information on type and duration of insulin therapy, carbohydrate counting, use of mobile applications for carbohydrate counting and perceived health status. Results: Older patients had higher BMI (r = 0.227, p = 0.037) and worse quality of life in the ‘barriers to activity’ domain (r = 0.290, p = 0.007). In the multivariate analysis, sociodemographic, clinical and quality of life characteristics significantly explained A1c (p = 0.046, η²_p = 0.271) and perceived health status (p = 0.012, η²_p = 0.313). Higher eating self-efficacy significantly explained better perceived health status (p = 0.006, η²_p = 0.105), but no variable independently had a significant effect on glycemic control. Conclusions: Glycemic control results from the interaction between various clinical features that must be considered in personalized approaches. Eating self-efficacy significantly explained perceived health status, and may represent a potential target for intervention among people with type 1 diabetes mellitus. Full article

Despite growing evidence on the influence of neighborhood characteristics on maternal well-being, there is a critical gap in the availability of validated instruments for measuring these constructs across different cultural settings. Existing neighborhood-related scales often lack cross-cultural validation, limiting their applicability in low- and middle-income countries. Understanding the impact of neighborhood characteristics is crucial given its multigenerational impact. We used data from the Evidence for Better Lives dataset to assess the conceptual and measurement equivalence of the community scales of neighborhood cohesion, intergenerational closure, and neighborhood and social disorder, testing for measurement invariance across eight low- and middle-income countries. Secondly, we examined patterns of associations with prenatal maternal stress, well-being, and depressive symptoms through the use of nomological networks. We found that the conceptual and measurement equivalence of the neighborhood domains were comparable across the eight studied countries. Additionally, our results suggest that higher levels of neighborhood and social disorder and lower levels of cohesion and intergenerational closure in the community are associated with adverse maternal outcomes across the included sites. The results of this study stress the importance of exploring the community context when assessing maternal well-being and supports the need to advocate for community-based interventions that promote safer physical and social environments within maternal programs and urban planning. Full article

Background/Objectives: Individuals with immunocompromising conditions are at high risk of developing severe respiratory syncytial virus (RSV) illness. This phase 3, single-arm study assessed the safety and immunogenicity of the bivalent RSV prefusion F protein−based (RSVpreF) 120-µg vaccine in immunocompromised and renally impaired adults. Methods: Participants were stratified by age group (18−<60-year-olds; ≥60-year-olds) and received two RSVpreF doses 1 month apart (i.e., Dose 1 and Dose 2, respectively). Reactogenicity events were collected for 7 days after each dose; adverse events through 1 month after the last dose; and serious adverse events, adverse events of special interest, and newly diagnosed chronic medical conditions throughout the study. Results: One month after Dose 1, RSVpreF elicited robust immune responses overall and across age and immunocompromised subgroups. Overall, geometric mean fold rises from before to 1 month after Dose 1 were high for RSV A and RSV B (8.3 and 9.0, respectively); no additional increases 1 month after Dose 2 (7.5 and 7.8) were observed. The most frequent local reaction was pain at the injection site, which was more common after Dose 2 than after Dose 1. The most frequent systemic event after any dose was fatigue. Most local reactions and systemic events were mild or moderate in severity. Adverse event and serious adverse event rates were 13.5% and 7.3% among 18−<60-year-olds and 22.4% and 14.0% among ≥60-year-olds, respectively. Conclusions: A single dose of the RSVpreF vaccine conferred robust immune responses in immunocompromised and renally impaired adults with no safety concerns. (ClinicalTrials.gov Identifier: NCT05842967). Full article

Many interconnected factors have been implicated in the prediction of whether a given individual occupies a managerial role. These include an assortment of demographic variables such as age and gender as well as trait emotional intelligence (trait EI) and cognitive ability. In order to disentangle their respective effects on formal leadership position, the present study compares a traditional linear approach in the form of a logistic regression with the results of a set of supervised machine learning (SML) algorithms. In addition to merely extending beyond linear effects, a series of techniques were incorporated so as to practically apply ML approaches and interpret their results, including feature importance and interactions. The results demonstrated the superior predictive strength of trait EI over cognitive ability, especially of its sociability factor, and supported the predictive utility of the random forest (RF) algorithm in this context. We thereby hope to contribute and support a developing trend of acknowledging the genuine complexity of real-world contexts such as leadership and provide direction for future investigations, including more sophisticated ML approaches. Full article

Current management paradigms suggest deferring grazing rangeland for two years post-fire to avoid additional stress on native grass species, but there is little research supporting these recommendations. This study was conducted within and adjacent to the burn area of a wildfire to evaluate the differences in diet quality, botanical composition, and foraging behavior of beef cattle on burned and unburned rangeland in the spring and fall of the year following a fire. Diet composition and masticate samples were collected during 20 min bite-count periods using six ruminally cannulated cows in burned and unburned sites in June and September. Diets differed between burned and unburned sites across seasons, but the differences were most apparent in June. Cattle grazed more selectively on burned sites in June, consuming a higher quality diet dominated by forbs. In September, cattle shifted to grass-dominated diets with fewer differences between burned and unburned sites. This indicates that the nutritional flush on post-fire rangelands may be minimized by the end of the first growing season post-fire. Additionally, in the first spring post-fire, cattle may shift grazing pressure away from vulnerable perennial native grass species to the early-seral forbs, commonly associated with the post-fire environment. Full article

Concomitant administration may improve vaccination rates. This analysis of a phase 1/2 randomized study included 1073 healthy ≥65-year-olds who previously received ≥3 mRNA COVID-19 vaccine doses. Participants received concomitantly administered RSVpreF and bivalent BA.4/BA.5-adapted BNT162b2 vaccine (concomitant administration) with or without quadrivalent influenza vaccine (QIV), admixed combined RSVpreF + BNT162b2 vaccine (combined vaccine) with or without QIV, RSVpreF, BNT162b2, or QIV. Immunogenicity objectives included demonstrating the noninferiority of neutralizing antibody titers elicited by concomitant administration and combined vaccine compared with RSVpreF or BNT162b2 administered alone, and by concomitant administration and combined vaccine given with QIV compared with RSVpreF, BNT162b2, and QIV alone. Reactogenicity (≤7 days) and safety ≤1 month (adverse events (AEs)) and ≤6 months (serious AEs (SAEs)) after vaccination were assessed. Noninferiority for all immunogenicity comparisons was demonstrated. All vaccine groups were well tolerated; no new safety concerns were identified. Reactogenicity was mostly mild/moderate with rates generally similar across groups, except injection site pain and fatigue, which were less frequent with RSVpreF + placebo vs. other groups. AEs were infrequent, mostly mild/moderate, occurring at similar frequencies across groups. No AEs leading to study withdrawal or vaccine-related SAEs were reported. Favorable safety and tolerability alongside similar immunogenicity provide support for concomitant or combined use of RSVpreF and BNT162b2, with or without QIV, to help protect older adults from these important respiratory pathogens (NCT05886777). Full article

Reduced efficacy of oral diuretics in the treatment of congestive heart failure (CHF) can be secondary to reduced enteral drug absorption. The aim of this study was to determine the efficacy of subcutaneous (SC) furosemide administration to control the signs of refractory CHF in dogs and cats and to assess the feasibility of this route of administration. The clinical records of 13 dogs and 17 cats with a history of refractory CHF treated with subcutaneous (SC) furosemide were reviewed retrospectively. Administration of SC furosemide was offered as an alternative therapy when animals experienced an unsatisfactory clinical response to oral diuretics despite multiple dose adjustments and when, for this reason, pet owners were considering euthanasia. The satisfactory control of the animal’s breathing rate and effort and overall pet owner’s satisfaction were observed in all cases. Following administration of SC furosemide, the median survival time was 106 (95% CI: 22–154) days in dogs and 89 (95% CI: 35 to 749) days in cats. This study showed that furosemide administered subcutaneously appears to be an efficacious and feasible therapeutic option for providing control of the signs of cardiac congestion in both dogs and cats with a previous unsatisfactory response to oral diuresis. Full article