GlaxoSmithKline (Belgium)

Abstract Background Respiratory syncytial virus (RSV) primarily affects the respiratory tract, with a high burden among older adults. We aimed to estimate the prevalence and characteristics of RSV-associated respiratory infections in community-dwelling older adults across Europe. Methods A prospective, observational study was conducted in six European countries over three consecutive RSV seasons (October 2021 until April 2024). Non-RSV vaccinated participants (age ≥60 years) presenting with symptoms of acute respiratory infection (ARI) at general practitioners and outpatient clinics/outpatient hospitals were recruited. Respiratory syncytial virus and other respiratory viruses were detected using a combined nasal and throat swab. Diary cards and regular phone contacts were used to collect information on onset and resolution of symptoms. The prevalence of RT-PCR confirmed RSV-ARI (cRSV-ARI) was estimated, as well as symptom duration, underlying comorbidities, prevalence of RT-PCR confirmed RSV lower respiratory tract disease (cRSV-LRTD), complications, hospitalizations, and co-infections. Results A total of 2573 participants were enrolled (139 with cRSV-ARI). The prevalence of cRSV-ARI varied by season: 3.6% in Season 1, 9.3% in Season 2, and 4.2% in Season 3. The most frequently reported upper respiratory, lower respiratory, and systemic symptoms were nasal congestion/rhinorrhea, cough, and fatigue (cRSV-ARI: 83.1%, 97.8%, and 64.0%; non-cRSV-ARI: 78.0%, 95.0%, and 68.2%). The overall prevalence of cRSV-LRTD was 3.9% in Season 1, 12.5% in Season 2, and 7.3% in Season 3. Conclusions This study highlights the substantial burden of RSV among older adults in Europe and reflects the shift in RSV epidemiology due to the COVID-19 pandemic, indicating a return to prepandemic seasonality trends. Clinical Trial Registration Not applicable

ABSTRACT Background Severe Plasmodium falciparum malaria is a leading cause of death in sub-Saharan Africa, with most deaths occurring in children younger than five years of age. The RTS,S/AS01 E (RTS,S) malaria vaccine delivered seasonally with Seasonal Malaria Chemoprevention (SMC) led to a two-third reduction in severe malaria and malaria deaths compared with either intervention given alone. The aim of this study was to assess the seasonal distribution and clinical presentation of children admitted in hospital with severe malaria who received RTS,S with or without SMC, and whether seasonal vaccination with RTS,S affected their distribution and clinical presentation. Methods We conducted a secondary ad-hoc analysis of hospital admissions in children aged 5 to 17 months of age when enrolled in the RTS,S + SMC trial in April 2017 in Houndé, Burkina Faso, and Bougouni, Mali, and who were followed until they reached five years of age. Results Three hundred and thirtythirty-seven serious adverse events were reported during the trial with 222 (65.9%) in Burkina Faso and 115 (34.1%) in Mali, and 48.1% (162/337) were due to severe malaria. The mean age of children with severe malaria was 2.9 years; 79.0% (128/162) of the cases occurred in children aged 3 years or less and 21.0% (34/162) in those aged 4 to 5 years. The most common presentation was severe anemia reported in 50% (81/162) of children, followed by repeated convulsions 25.3%, (41/162), prostration 11.1%, (18/162), hyperparasitaemia 8.0%, (13/162) and cerebral malaria 6.2%, (10/162). Severe malaria anemia was a more frequent form of severe malaria in children in the SMC alone arm 62.1%, (36/58) and lower in children in the SMC+ RTS,S arm 37.1%, (13/35), p=0.048. There was no significant difference in frequency of other clinical presentations between the study arms. Most severe malaria cases, 85.8% (139/162) occurred during the transmission season (July to December). Conclusions Severe anaemia was the most common presentation of severe malaria and was most frequent in the SMC alone arm. Children aged 3 years or less were the most affected and almost all the cases occurred between July and December. Trial registration ClinicalTrials.gov , NCT04319380

Background4CMenB (MenB-4C, GSK) has been licensed in the US since 2015 for individuals aged 10–25 years. This study assessed its safety and immunogenicity in US infants when administered concomitantly with PCV13 (Pfizer) and other US-recommended RIVs.MethodsThis phase 3B, observer-blind, randomized, placebo-controlled, multicenter study (NCT03621670) randomized (2:1 ratio) 1195 healthy US infants aged 6–12 weeks to receive, at approx. 2, 4, 6, and 12 months of age, either 4CMenB administered concomitantly with PCV13 and other RIVs (N=786; 4CMenB+RIVs) or placebo with PCV13 and other RIVs (N=409; Placebo+RIVs). Primary objectives were to assess vaccine safety, demonstrate sufficiency of immune responses to 4CMenB by human serum bactericidal assay (hSBA) against each of 4 serogroup B (MenB) indicator strains and all strains combined (composite), and non-inferiority of pneumococcal serotype-specific geometric mean antibody concentrations (GMCs).ResultsPre-specified sufficiency criteria 1 month post-dose 3 (based on lower limit [LL] of 99.2% confidence interval [CI] for hSBA titers ≥lower limit of quantitation [LLOQ]) and post-dose 4 (based on LL of 95.8% CI for hSBA titers ≥8/16) were met for fHbp, NadA, and PorA strains, but not for NHBA and the composite response. For NHBA, the CI LL for percentage of participants with hSBA titers ≥8 post-dose 4 was 72.5% (sufficiency criterion: ≥75%). Percentages of participants with hSBA titers ≥LLOQ against each MenB indicator strain post-dose 4 were 86.1%–99.6% (75.7%, composite) in the 4CMenB+RIVs group vs 0.0%–2.8% (0.0%, composite) in the Placebo+RIVs group. The success criterion for immunological non-inferiority of PCV13 (4CMenB+RIVs) vs PCV13 (Placebo+RIVs) was met for each PCV13 antigen (see table). 4CMenB was well tolerated, with no major between-group differences in unsolicited adverse events and no safety concerns identified.Conclusion4CMenB was well tolerated and immunogenic in US infants, with no clinically significant interference against concomitantly administered RIV. Comparison against the 4CMenB-naïve group shows MenB immune responses in the 4CMenB+RIVs group were elicited solely by 4CMenB.Acknowledgements: Enovalife Medical Communication Service Center, on behalf of GSK (writer: J. Knowles).Funding: GSK.DisclosuresAll Authors: No reported disclosures

Congenital cytomegalovirus (cCMV) is the most common congenital infection worldwide. cCMV can result in long-term impairments such as hearing loss and developmental delay. The study objective was to understand the caregiver experience of cCMV and caregiver-reported perceptions of the experience for cCMV patients. This non-interventional, cross-sectional study interviewed 25 caregivers of patients (aged 4 months to 17 years) with confirmed cCMV in the United States. Semi-structured qualitative interviewing methods were used to elicit descriptions of cCMV symptoms and their impact on the patient as perceived by the caregiver. Separate questions assessed the caregiver burden of a patient with cCMV. Transcripts were analyzed using an iterative coding process to identify key concepts. All caregivers reported increased healthcare needs for their child with cCMV. Other caregiver-reported patient impacts spanned multiple domains including emotional, physical and social functioning, education and communication. For example, a child with cCMV-related communication/hearing difficulties experiencing sadness or social isolation, or with cCMV-related seizures resulting in worry or apprehension. The caregiver impacts of caring for a child with cCMV also covered multiple domains including emotional, role and social functioning, work, sleep, and family planning. Emotional functioning was considered the greatest impact by approximately half of caregivers. These results advance understanding of experiences related to cCMV for caregivers and caregiver-reported perceptions of the patient experience. This may help healthcare professionals improve routine clinical practice for families affected by cCMV. The results and conceptual model may also support the development of a disease-specific clinical outcome assessment tool. Cytomegalovirus is a common virus, usually mild in healthy adults, that can be passed to an unborn baby during pregnancy (congenital cytomegalovirus). Some babies born with congenital cytomegalovirus have long-term health problems, such as hearing loss or learning disabilities. This study interviewed 25 parents caring for children with congenital cytomegalovirus in the United States to explore the impact of the disease on the lives of patients and caregivers. Impacts of congenital cytomegalovirus on the children, as reported by the caregivers, included emotional (e.g., anxiety, fear, worry), physical (e.g., needing devices to assist hearing) or social effects (e.g., social withdrawal), or difficulties with education or communication. All caregivers reported emotional impacts such as feelings of shock, anxiety, and fear, sometimes lasting a long time as parents worried about potential future impacts of congenital cytomegalovirus on their child. These results help to understand the impacts of congenital cytomegalovirus on the lives of patients and their families.

Health state utility values (HSUVs) are vital in cost-utility analyses (CUAs) that inform policymaking. However, suboptimal selection and application of HSUVs have been reported in areas such as cardiovascular disease and cancer. This study reviewed the methodological quality and appropriateness of HSUV in CUA use for interventions targeting infectious diseases in aging populations. A systematic search of the MEDLINE database was conducted to identify CUAs that evaluated interventions against six major infectious diseases from January 2000 to July 2025. Two reviewers independently screened the identified studies based on eligibility criteria. The two reviewers then assessed the included studies using a modified checklist that covered how HSUVs were selected, elicited, and applied. Findings are summarized by descriptive statistics across the entire period (January 2000 to July 2025) and three sub-periods (2000-2009, 2010-2019, and 2020 to July 2025). Among the 146 included CUA studies, only 10 (7%) relied exclusively on original sources for HSUVs, while 78% used economic data, either alone or in combination with other secondary sources or assumptions. Most studies (78-91%) did not provide sufficient rationale or descriptions for the population or how HSUVs were elicited, and 42% failed to report all utility components. Complete comparability between the CUAs and reference data for the diagnosis, severity, and country was observed in only 51-60% of studies. Notably, fewer than half of CUAs reported HSUVs that were consistent with their cited sources, and 80% did not discuss the limitations associated with HSUV use. Most criteria showed limited improvements, and in some cases declines, between January 2000 and July 2025. CUAs of infectious diseases in aging populations are frequently associated with suboptimal practices in how HSUVs are selected, elicited, and applied. These shortcomings highlight the need for cautious interpretation of CUA data and for greater methodological transparency. Improving the quality of economic evaluations will require systematic approaches to how HSUVs are selected and elicited, with increased investment in primary data collection and the creation of accessible utility databases.

An advisory board meeting was held with five participants living with chronic respiratory conditions or having experienced a severe episode of respiratory syncytial virus (RSV) infection, to understand the challenges faced by such individuals and their experiences with lung health. In this podcast, we relate the points discussed during that meeting, providing further reflections from a patient and a physician on awareness, the lived experience of RSV, the risks it poses to adults living with chronic respiratory conditions and healthcare system support in managing lung health. Experiences shared by participants illustrate how RSV and chronic respiratory conditions can impact many aspects of a person’s life, beyond the acute illness, such as feelings of isolation. While many individuals are at risk of severe outcomes from RSV infection, the general population and healthcare practitioners (HCPs) are often unaware of the disease and its potential consequences in adults. Knowing the risk factors for severe RSV and exacerbation of underlying conditions, such as chronic obstructive pulmonary disease, asthma and cardiovascular diseases, could support physicians in discussing risks and preventive measures with their patients. This could help align patients’ expectations of HCPs and the healthcare system with the care they receive by providing more guidance on the multifactorial management of their respiratory health. Discussions about the preferred sources of information identified patient groups as the most trustworthy source, followed by HCPs, who can play a key role in helping patients to identify reliable sources of information. Despite involving only a small group of people, the discussion provided valuable insights from participants which can raise awareness about the risks and impact of RSV on people’s lives and empower healthcare professionals to better support their patients in managing their patients’ lung health.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40121-025-01216-0.

Limited data are available on the epidemiology and clinical burden of respiratory syncytial virus (RSV) among adults with underlying medical or immunocompromising conditions ("high-risk adults") and ≥ 50-year-old adults in developing countries. To better understand the impact of RSV in these populations, a systematic literature review of articles published from the year 2000 onward reporting RSV data among high-risk 18-59-year-old adults and ≥ 50-year-old adults in low, lower-middle, upper-middle, and selected high-income countries was undertaken. Searches were run on Medical Literature Analysis and Retrieval System Online (MEDLINE) and Excerpta Medica DataBASE (EMBASE), and were supplemented by additional searches (e.g., congress abstracts, gray literature). A combination of artificial intelligence models was used for title/abstract screening. After this, full-text screening of inclusions was conducted, followed by prioritization. Overall, 77 citations were selected for final inclusion. Of these, 69 reported outcomes related to RSV epidemiology and clinical burden, and are reported in this article. There were limited data on RSV incidence, prevalence, disease severity, and subtype distribution. Adequate evidence was available for RSV positivity among patients with respiratory illnesses, seasonality, complications, and mortality. Incidence in ≥ 65-year-olds was in the range of ~10-178 episodes per 1000 person-years across studies. Ranges for RSV positivity among patients with different underlying respiratory conditions were 1.5-31.9% and 0-9.1%, in high-risk and ≥ 50-year-old adults, respectively. Case fatality rates of up to 15.2% and 27.0% were reported across studies for high-risk and > 60-year-old adults, respectively. Overall, there were considerable evidence gaps for RSV epidemiology among high-risk and ≥ 50-year-old adults in developing countries. However, available data indicate a substantial negative health impact of RSV on these populations, highlighting the need for further data generation.