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Introduction: Invasive meningococcal disease (IMD) is a severe and life-threatening disease. In the United States (US), vaccine coverage with MenACWY and MenB meningococcal vaccines is suboptimal among adolescents/young adults aged 16-23 years. A combined meningococcal vaccine (MenABCWY) could increase convenience (e.g., fewer injections) and improve coverage. The objective was to quantify preferences for hypothetical meningococcal vaccine profiles among adolescents/young adults and parents., Methods: An online discrete choice experiment was conducted among 16- to 23-year-olds, and parents of 16- to 18-year-olds. Attributes (3 × 4) and levels (1 × 2) were based on the literature and focus groups. Participants made ten pair-wise forced trade-off choices, systematically varied using a D-optimal design. Random parameter logit quantified the relative importance of vaccination attributes and estimated the trade-offs. Differences in preferences by subgroups were assessed., Results: Totals of 300 adolescents and young adults (median age 20 years) and 300 parents (median age 46 years) completed the survey. Overall, 89.6% of 16- to 23-year-olds and 69.1% of parents preferred a simplified hypothetical meningococcal vaccination profile, e.g., with fewer injections (3 vs. 4) and fewer healthcare provider (HCP) visits (2-3 vs. 4). Having HCP advice and clear Centers for Disease Control and Prevention recommendations impacted vaccination choice, with both groups reporting high trust in HCP information (83.3% among 16- to 23-year-olds; 98.7% among parents). Barriers to vaccination included lack of HCP advice or awareness of meningococcal vaccines, and income level and out-of-pocket costs for parents., Conclusions: Adolescents/young adults and parents demonstrated a significant preference for a meningococcal vaccine that is more convenient (such as combined MenABCWY). Parents' vaccination preferences differed by income level and out-of-pocket costs, suggesting financial barriers to vaccination may exist which could result in IMD prevention inequalities. Findings from this study provide important information to support patient-facing informed policy discussions. A simplified vaccination schedule and strong recommendation could help improve vaccine uptake, schedule compliance, disease prevention, and reduce inequalities in IMD risk and prevention. A graphical abstract is available with this article., (© 2024. GSK.)

Background: Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022)., Methods: In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models., Results: In the RSVPreF3 OA group ( N  = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group ( N  = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p  = 0.0258. LSMean group differences for the PF and EQ-5D health utility score were 7.00 (95% confidence interval [CI]: -9.86, 23.85; p  = 0.4125) and 0.0786 (95% CI: -0.0340, 0.1913; p  = 0.1695)., Conclusions: The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility., Competing Interests: During this study, Eliazar Sabater Cabrera, Desmond Curran, Veronica Hulstrøm, Lusine Kostanyan, and Daniel Molnar were GSK employees. Eliazar Sabater Cabrera, Desmond Curran, Veronica Hulstrøm, Lusine Kostanyan, and Daniel Molnar hold shares in GSK. Isabel Maria Galan Melendez was an investigator for the study of RSV OA‐006 and declares to have received payments from GSK per contract, as well as equipment on loan and study materials. Silvia Narejos Pérez participated as principal investigator (PI) in clinical trials with different sponsors, including GSK and received financial support during the present manuscript. As a PI, she collaborated in the presentation of the results of clinical trials of vaccines and received financial support for attending meetings and/or travel. Laura Helman received payment for completing the study work and was given financial support for attending meetings and/or travel as an investigator. During the development of the study, John H. Powers III was a consultant for GSK and Vir on the clinical study design. Besides that, he received consulting fees from Adaptive Phage, Arrevus, Atheln, Bavarian Nordic, Cellularity, Eicos, Evofem, Eyecheck, Gilead, Mustang, OPKO, Otsuka, Resolve, Romark, Spine BioPharma, and UTIlity. He is an unpaid board member of Health Literacy Media. Mika Rämet declares that his institute was sponsored by GSK to perform the current study. Tino Schwarz has received honoraria for lecturing or advisory boards from Alexion, AstraZeneca, Bavarian Nordic, Biogen, Biontech, CSL Seqirus, GSK, Janssen‐Cilag, Merck‐Serono, Moderna, MSD, Novavax, Pfizer, Roche, Sanofi‐Aventis, and Takeda and for conducting clinical vaccine trials from GSK, Pfizer, Clover Biopharmaceuticals, and Serum Institute of India. Brigitte Stephan participated as investigator in clinical trials with different sponsors, including GSK. Sean Matthews, Lina Pérez Breva, Nathalie Roy, Dae Won Park, and Axel Schaefer have nothing to declare., (© 2024 GSK. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

The development and demand for effective vaccines have witnessed an exponential growth over the last century. In the meantime, the vaccine market involves more knowledgeable stakeholders, with a shift in emphasis by regulatory agencies on understanding the patient perception and experience. The Food and Drug Administration's publication of the patient-reported outcomes (PRO) guidance has elevated the discipline of PROs and has resulted in a transition from clinician reports of patient outcomes to PROs. This review reports various research methods, which utilize PROs, including qualitative and quantitative research, clinical trials, and patient preference studies. With the advancement of electronic PRO data capture, additional advantages of PROs are being observed and utilized (e.g. as a trigger for clinical endpoints). We discuss uses and advantages of including PROs into the clinical trial program to improve efficiencies, clinical relevance and overall validity of the program in the vaccine field. (See Plain Language Summary).

Background: Information about the impact of respiratory syncytial virus (RSV) on quality of life in older adults is limited. This study characterized the patient experience of RSV illness in USA older adults and assessed the content validity of the InFLUenza Patient Reported Outcome (FLU-PRO) in this population., Methods: This qualitative, non-interventional, cross-sectional study included hybrid concept elicitation and cognitive debriefing interviews with 30 individuals (age ≥50 years) with polymerase chain reaction-confirmed RSV diagnosed within 6 months of screening. Targeted literature review was first conducted to inform the development of interview materials. Webcam or telephone interviews were conducted by qualitative researchers using a semistructured interview guide. Interview transcripts were coded and analyzed using Excel and NVivo software., Results: All participants reported impacts on daily activities, social activities, and relationships during RSV disease. Physical functioning was impaired in 25 (83%) participants, and 18 (60%) reported not engaging in leisure activities/hobbies. All nine participants who were working reported major impacts on work. Most (n = 28; 93%) described emotional impacts. A majority (n = 19; 63%) reported symptoms lasting beyond the acute disease stage from a week to >1 month. Symptom concepts reported generally matched FLU-PRO items and domains. Cognitive debriefing indicated that FLU-PRO was easy to understand and captured participants' experiences of RSV illness., Conclusions: This study indicates that RSV disease in adults aged ≥50 years in the USA has substantial impacts on daily life and that the concepts included in FLU-PRO are appropriate and fit for purpose as a measure of RSV symptoms in this population., (© 2021 GlaxoSmithKline Pharmaceuticals S.A. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

The scope of this paper is to analyze and compare the evolution of deaths from violent causes among adolescents and young adults in the cities of Cordoba (Argentina) and Porto Alegre (Brazil). It also seeks to establish if the results are consistent with those reported in previous national and local research. Based on official data, specific mortality rates (by sex, age and cause) are calculated for the 1990-92 and 2008-10 periods. In general, violent causes play a significant part in the total number of deaths especially among young men and as they get older. In line with the reality of the country, in Córdoba both non-traffic-related and also traffic-related deaths are most frequent. On the other hand, in Porto Alegre (where the level of deaths from violent causes is higher), homicides and traffic accidents are the most common cause of death. Beyond the actions taken so far, it is necessary to redouble efforts to counter the problem in question, both in the recording of information for decision-making and in regard to the decisions when they are put into practice.

We have studied the effect of the administration of two doses of melatonin (melatonin 100 and melatonin 200 microg/kg bw) on diabetes and oxidative stress experimentally induced by the injection of streptozotocin (STZ) in female Wistar rats. STZ was injected as a single dose (60 mg/kg i.p. in buffered citrate solution, pH 4.0) and melatonin (melatonin 100, 100 microg/kg/day i.p.; melatonin 200, 200 microg/kg/day i.p.) beginning 3 days before diabetes induction and continuing until the end of the study (8 weeks). The parameters analysed to evaluate oxidative stress and the diabetic state were a) for oxidative stress, changes of lipoperoxides (i.e., malondialdehyde, MDA) in plasma and erythrocytes and the changes in reduced glutathione (GSH) in erythrocytes and b) for diabetes, changes in glycemia, lipids (triglycerides: TG; total cholesterol: TC; HDL-cholesterol, HDL-c), percentage of glycosylated hemoglobin (Hb%), and plasma fructosamine. The injection of STZ caused significant increases in the levels of glycemia, percentage of glycosylated hemoglobin, fructosamine, cholesterol, triglycerides, and lipoperoxides in plasma and erythrocytes, whereas it decreased the levels of HDL-c and the GSH content in erythrocytes. The melatonin 100 dose reduced significantly all these increases, except the percentage of glycosylated hemoglobin. With regard to the decreases of plasma HDL-c and GSH content in erythrocytes, this melatonin dose returned them to normal levels. The melatonin 200 dose produced similar changes, though the effects were especially noticeable in the decrease of glycemia (55% vs. diabetes), percentage of hemoglobin (P < 0.001 vs diabetes), and fructosamine (31% vs. diabetes). This dose also reversed the decreases of HDL-c and GSH in erythrocytes. Both doses of melatonin caused significant reduction of the percentage of glycosylated hemoglobin in those groups that were non-diabetic. These illustrate the protective effect of melatonin against oxidative stress and the severity of diabetes induced by STZ. In particular, this study confirms two facts: 1) the powerful antioxidant action of this pineal indole and 2) the importance of the severity of oxidative stress to maintain hyperglycemia and protein glycosylation, two pathogenetic cornerstones indicative of diabetic complications. Melatonin reduces remarkably the degree of lipoperoxidation, hyperglycemia, and protein glycosylation, which gives hope to a promising perspective of this product, together with other biological antioxidants, in the treatment of diabetic complications where oxidative stress, either in a high or in a low degree, is present.