Arexvy (respiratory syncytial virus vaccine, adjuvanted) / GSK - LARVOL DELTA

Immunogenicity and Safety of RSVPreF3 OA Coadministration Versus Sequential Administration in Adults: A Systematic Review and Meta-Analysis. (PubMed, Vaccines (Basel)) - "In adults aged 50 years or older, same-day RSVPreF3 OA coadministration was associated with lower RSV-neutralizing antibody responses than sequential administration, while partner-vaccine immunogenicity varied by product and antigen. Non-inferiority was not demonstrated for the SARS-CoV-2 XBB.1.5 and adjuvanted-QIV A/H3N2 antibody endpoints. No clear safety difference between schedules was identified, and the clinical significance of the antibody differences remains uncertain."

Journal • Retrospective data • Review • Herpes Zoster • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Varicella Zoster

RSV Immunogenicity Study in the Elderly (RISE) (clinicaltrials.gov) - P3 | N=75 | Active, not recruiting | Sponsor: Karin Karin Loré | Recruiting ➔ Active, not recruiting

Enrollment closed

Construction and application of a novel respiratory syncytial virus vaccine based on Bacteroides thetaiotaomicron outer membrane vesicles. (PubMed, Front Microbiol) - "For instance, Abrysvo and Arexvy pose potential safety risks in clinical use, and the long-term protective efficacy of mRESVIA may wane over time...This strategy capitalizes on the unique advantages of Bt OMVs, including efficient mucosal delivery, low inherent toxicity, and targeted modulation of T cell homeostasis-specifically enhancing Treg and Th1 responses while suppressing excessive Th2 and Th17 activation, which serves as the core mechanism for preventing vaccine-enhanced disease (VED)-to effectively present the RSV F protein antigen. It offers a novel approach to develop next-generation RSV vaccines that combine durable protection with enhanced clinical safety."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A comprehensive look at Respiratory Syncytial Virus (RSV): from pathogenesis to prevention. (PubMed, Trop Dis Travel Med Vaccines) - "Until now, three RSV vaccines, Arexvy, Abrysvo, and mRESVIA, have received approval from the FDA. In addition, monoclonal antibodies such as Nirsevimab and Clesrovimab prevent severe RSV disease and are recommended for infants. Given the significant global impact of RSV, this narrative review addresses its multifaceted aspects, including epidemiology and global impact, clinical manifestations, therapeutic strategies, vaccine development, and its emerging potential as an oncolytic agent."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Temporal and disproportionality analysis of vaccine-associated Guillain-Barré syndrome: a 21-year VAERS study. (PubMed, Front Neurol) - "Novel signals emerged for both RSV vaccines (Arexvy ROR 3.01, Abrysvo ROR 6.82) and zoster vaccine (ROR 3.01), consistent with post-marketing estimates of 3-9 excess cases per million doses...Multiple vaccines showed disproportionate GBS reporting signals with delayed temporal patterns consistent with biological plausibility; because these derive from passive surveillance, they are hypothesis-generating and do not establish causality. Despite rare associations, absolute risks (1-9 per million doses) are far outweighed by disease prevention benefits, supporting current vaccination policies with ongoing surveillance."

Journal • Herpes Zoster • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Adult immunization. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus • Varicella Zoster

Comparison chart: Some vaccines for adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

Respiratory Syncytial Virus in Adults in India: An Under-recognized Public Health Concern Demanding Urgent Immunization Action. (PubMed, Indian J Med Microbiol) - "Three vaccines-GSK Arexvy, Pfizer Abrysvo and Moderna mRNA-1345 are currently approved for adults ≥60 years in the United States and Europe...In India, CDSCO conditionally approved Phase III trials of RSVPreF in June 2025, but no adult RSV vaccine is licensed for use. This review proposes for integration of routine RSV molecular testing and reporting with outcome especially in comorbid adults, inclusion of RSV vaccination in National Technical Advisory Group on Immunisation (NTAGI) deliberations for elder and high-risk groups, accelerated regulatory pathways leveraging global bridging data and implementation of prospective multicenter studies to generate robust evidence for health technology assessment, cost-effectiveness and policy formulation."

Journal • Infectious Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Summary of the National Advisory Committee on Immunization (NACI) Statement: Updated guidance on respiratory syncytial virus (RSV) vaccines for older adults and for adults at high risk of severe RSV disease. (PubMed, Can Commun Dis Rep) - "NACI strongly recommends RSV immunization programs for all adults aged 75 years and older; adults aged 65-74 who are at increased risk of severe RSV disease; and adults aged 18 years and older who reside in chronic care facilities, have received a lung or hematopoietic stem cell transplant, are receiving home or chronic oxygen therapy, or are receiving dialysis. For other adults, vaccination may be considered on an individual basis."

Journal • Bone Marrow Transplantation • Cardiovascular • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease (clinicaltrials.gov) - P3 | N=750 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=350 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2026 ➔ Nov 2036 | Trial primary completion date: Aug 2026 ➔ Nov 2036

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=350 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | N=500 ➔ 350

Enrollment change • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

Adverse events and vaccine administration errors following RSV vaccination: Findings from the United States VAERS database, 2023-2025. (PubMed, Vaccine) - "Most AE reports following RSV vaccination were non-serious. The potential misuse of Arexvy® during pregnancy and excess dose for both Arexvy® and Abrysvo® highlight potential gaps in healthcare provider education and vaccine record retrieval."

Adverse events • Journal • Dermatology • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Respiratory syncytial virus vaccination induces delayed but robust humoral and cellular immunity in patients receiving hemodialysis. (PubMed, Kidney Int) - "We conducted an observational study of 20 patients receiving hemodialysis (median age 78.4 years; 55% female; median dialysis duration 23 months) who received a single dose of the RSV vaccine Arexvy...Attenuated antibody responses with longer dialysis duration suggest dialysis vintage as a key determinant of vaccine efficacy in this high-risk population. The increase in anti-RSV IgG antibody levels was significantly delayed in patients receiving hemodialysis compared to control individuals."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4 • CXCL8 • IFNG • IL2 • IL23A

Immunogenicity and reactogenicity of the adjuvanted respiratory syncytial virus vaccine in patients with chronic kidney disease (ERA 2026) - "Recently, vaccines such as the protein-based adjuvanted RSVPreF3–AS01E (Arexvy), targeting the RSV prefusion F glycoprotein, have been approved for the prevention of severe RSV disease in high-risk populations...This effect was mostly attributable to the humoral vaccine response. These findings may support the development of more individualized vaccination strategies in CKD cohorts."

Clinical • Chronic Kidney Disease • Musculoskeletal Pain • Nephrology • Renal Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4 • CD8

Safety, immunogenicity, and dose ranging of a bivalent respiratory syncytial virus and human metapneumovirus glycoprotein F-molecular clamp vaccine candidate in older adults: 1-month interim analysis of an ongoing randomised, observer-blind, placebo- and active-controlled, phase 1 trial. (PubMed, Vaccine) - "VXB-241 showed a clinically acceptable safety and reactogenicity profile and elicited strong neutralising immune responses against RSV and hMPV in older adults. Neutralising immune responses against RSV-A and RSV-B by VXB-241 were at least as good as those obtained with the licensed adjuvanted RSVPreF3 active control."

First-in-human • Journal • P1 data • Geriatric Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections

GSK plc reports that Japan's Ministry of Health, Labour and Welfare has expanded approval of its RSV vaccine Arexvy to include adults aged 18-49 years at increased risk for RSV disease. (StockTitan.net) - "Supportive evidence includes a Phase IIIb immunogenicity trial in 18-49-year-old at-risk adults and earlier Phase III efficacy data in adults 60 and above. The safety profile matched prior Phase III results, with mostly transient, mild-to-moderate local and systemic reactions."

Japan approval • Respiratory Syncytial Virus Infections

Durability of Immunity from Adjuvanted Respiratory Syncytial Virus (RSV) Vaccination in Lung Transplant Recipients (ISHLT 2026) - "40 adult LT (≥3 months post-transplant) recipients who were stable outpatients have been enrolled and administered a single dose of adjuvanted RSVPreF3 vaccine (Arexvy, GSK)...Secondary outcomes include RSVPreF IgG antibody and RSV-specific CD4+ and CD8+ T cell levels at V6 and V12, compared with earlier timepoints. Other outcomes of interest include RSV breakthrough infection, hospitalization and acute graft rejection episodes until V12."

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplant Rejection • Transplantation • CD4 • CD8

RSVax: RSV Vaccine in Transplant Recipients (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: University Health Network, Toronto | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Sep 2026 | Trial primary completion date: Mar 2026 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

In Brief: RSV vaccine (Arexvy) for ages 18-49. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Respiratory Syncytial Virus Infections

Respiratory syncytial virus (RSV) vaccination program for older Australians reduces health inequalities: a distributional cost-effectiveness analysis. (PubMed, Vaccine) - "RSV vaccination for Australians aged ≥75 years could improve overall population health and reduce existing health inequalities. However, the net health benefits were sensitive to the potential vaccine price to be negotiated by the government in Australia for older adults."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Estimating the cost-effectiveness of respiratory syncytial virus (RSV) vaccination program for older Australian adults. (PubMed, Vaccine) - "An RSV vaccination program for older Australians substantially reduced RSV hospitalisations, associated costs, and mortality. An RSV vaccination program is likely to be cost-effective in Australians aged ≥75 years if an appropriate vaccine price can be negotiated."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

GLUT1 in Memory CD4+ T-cells Correlates with Sustained Antibody Responses and Polyfunctionality Post-RSV Vaccination in Immunocompromised Individuals (IMMUNOLOGY 2026) - "To address this gap, T-cell responses were evaluated in immunocompromised individuals who received an approved RSV prefusion F (preF) protein subunit vaccine. In a national prospective observational cohort, 44 immunocompromised individuals reported receiving either adjuvanted RSVPreF3 (AREXVY™) or unadjuvanted RSVpreF (ABRYSVO™)... These findings suggest that sustained T-cell metabolic fitness, as indicated by GLUT1, may be linked to the durability of both cellular and humoral immune responses. Understanding the role of GLUT1 in shaping immune responses may provide novel methods for optimizing vaccine strategies for immunocompromised individuals."

Clinical • Immunology • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • CD4 • IFNG • IL2 • SLC2A1

Quantifying vaccine dissemination for uptake comparisons between vaccines. (PubMed, Hum Vaccin Immunother) - "The five vaccines were Arexvy, Comirnaty, Gardasil/Gardasil 9, Heplisav-B, and the ID Biomedical H1N1 Monovalent Vaccine. Collection, mapping, and analysis of estimated vaccine diffusion curves inform understanding of vaccine hesitancy and the impact of strategies and tactics to improve and accelerate vaccine uptake."

Clinical • Journal • Hepatitis B • Infectious Disease • Novel Coronavirus Disease

RSV Vaccination to Reduce Recurrent AECOPD (clinicaltrials.gov) - P4 | N=320 | Not yet recruiting | Sponsor: Chinese University of Hong Kong

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections