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

Durability of RSV Antibodies Following RSV Vaccination in Solid Organ Transplant Recipients (WTC 2025) - "In healthy populations, antibody (Ab) response and clinical protection last for >1 year following a single vaccine dose, yet Ab durability in SOTRs is not known and may inform role for additional doses.* In a national prospective cohort, we measured Anti-RSV Pre-Fusion F IgG (PreF Ab) using an electrochemiluminescence assay (Meso Scale Discovery) in SOTRs who received RSVPreF3 (AREXVY™, RSV-AS01E) or RSVpreF (ABRYSVO™, RSV-A/B) vaccines between October 2023-October 2024 at baseline, and 4, 12, and 26-weeks post-vaccination... Longitudinal data indicate relatively stable Ab levels out to 6 months post RSV vaccination in SOTRs. However, many SOTRs never achieve conservative thresholds of Ab response, suggesting ongoing vulnerability to infection and supporting investigation of additional primary vaccinations for frailer or more immunosuppressed subgroups."

Clinical • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplantation

RSV Vaccination Increases CD4 T-Cell Response, but Not CD8, in Solid Organ Transplant Recipients (WTC 2025) - "To address this gap, RSV-specific T-cell responses pre- and post-vaccination were assessed in SOTRs who received an approved RSV prefusion F protein vaccine.* In a national prospective cohort of SOTRs reporting either adjuvanted RSVPreF3 (GSK, AREXVY™) or unadjuvanted RSVpreF (Pfizer, ABRYSVO™) vaccination, RSV F-specific T-cell responses were evaluated by intracellular cytokine staining and flow cytometry following RSV peptide pool stimulation... RSV vaccination increases RSV F-specific CD4+ T-cell response but does not significantly increase CD8+ T-cell responses in SOTRs. The lack of virus-specific cytotoxic T-cell response in SOTRs may suggest ongoing vulnerability to critical disease despite vaccination, particularly if humoral response wanes. Importantly, a subset of SOTRs exhibited no significant increase in CD4+ T-cell responses following vaccination, highlighting the need for further investigation into predictors of response."

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplantation • CD4 • CD8 • IFNG • IL2

GSK delivers continued strong performance (GSK Press Release) - "Total Q2 2025 sales £8.0 billion +1% AER; +6% CER Specialty Medicines sales £3.3 billion (+15%); Respiratory, Immunology & Inflammation £1.0 billion (+10%); Oncology £0.5 billion (+42%); HIV sales £1.9 billion (+12%) Vaccines sales £2.1 billion (+9%); Shingrix £0.9 billion (+6%); Meningitis vaccines £0.4 billion (+22%); and Arexvy £0.1 billion (+13%) General Medicines sales £2.6 billion (-6%); Trelegy £0.8 billion (+4%) Total operating profit +33% and Total EPS +35% driven by lower CCL charges partly offset by intangible asset impairments Core operating profit +12% and Core EPS +15% reflecting Specialty Medicines and Vaccines growth, higher royalty income and disciplined increased investment in R&D portfolio progression in Oncology and Vaccines"

Commercial • Chronic Obstructive Pulmonary Disease • Respiratory Syncytial Virus Infections

Adjuvanted respiratory syncytial virus (RSV) vaccination in high-risk transplant recipients (WTC 2025) - "Stable outpatients who were ≥3 months post-LT or ≥6 months post-alloHCT received a single dose of adjuvanted RSV vaccine (Arexvy)... The adjuvanted RSV vaccine was safe and elicited robust CD4+ T-cell responses in both LT and alloHCT recipients, although seroconversion rates were modest. Given the importance of humoral and CD8+ T-cell immunity, further investigation of strategies to optimize protection from RSV, including a second dose of vaccine, may be warranted."

Clinical • Late-breaking abstract • Graft versus Host Disease • Immunology • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation • CD4 • CD8

Long-Term Safety of Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients (WTC 2025) - "Outcomes were stratified by vaccine type received (adjuvanted RSVPreF3-AS01E [GSK, Arexvy] or non-adjuvanted RSVPreF-A/B [Pfizer, Abrysvo]).* Between August 2023-December 2024, 85 SOTRs reported RSV vaccination of whom 81 (95%) returned ≥1 safety survey and 68 (80%) returned reactogenicity surveys including 12/68 (18%) with vaccine coadministration... RSV vaccines are safe in SOTRs, without signals for immune-related or neurological events in long-term follow-up. Reactogenicity is generally mild and higher following adjuvanted vaccination."

Clinical • Cardiovascular • Immunology • Infectious Disease • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplant Rejection • Transplantation

Equivalent RSV Specific IgG and IgA Increases After Vaccination in Transplant Recipients (WTC 2025) - "The goal of this study was to define the antibody isotypes produced and F protein conformations targeted by SOTRs in response to RSV vaccination.* In a national prospective cohort of SOTRs reporting RSV vaccination with RSVPreF3 (GSK, AREXVY™) or RSVPreF (Pfizer, ABRYSVO™), we measured RSV preF and postF IgG and IgA binding by ELISA (area under the curve (AUC)) and neutralizing titers using a live virus neutralization assay at baseline and 4 weeks post vaccination.* 19 participants reported an RSV vaccine between October 2023 and July 2024 (Table)... The increase in IgG and IgA preF and postF binding suggests that much of the response to RSV vaccines in SOTRs is due to boosting of preexisting antibodies. The significant increase in IgA preF as compared to postF, and the strong correlation of both isotypes to serum neutralizing capacity, indicates that IgA may be an important part of the RSV vaccine response in SOTRs."

Clinical • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplantation

Effectiveness of the Arexvy RSV vaccine in lung transplant recipients: Neutralizing antibody response against reference and seasonal strains (ERS 2025) - No abstract available

Clinical • Respiratory Syncytial Virus Infections • Transplantation

Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023-December 2024. (PubMed, Prev Med Rep) - "Preterm delivery and GBS following the administration of RSV vaccines require continuous monitoring. Additionally, inappropriate administration of Arexvy in pregnant individuals should be paid attention to."

Adverse events • Journal • Cardiovascular • Dermatology • Respiratory Diseases • Respiratory Syncytial Virus Infections

A second-generation molecular clamp stabilised bivalent candidate vaccine for protection against diseases caused by respiratory syncytial virus and human metapneumovirus. (PubMed, PLoS Pathog) - P1 | "Head-to-head evaluation in mouse immunogenicity studies showed that the VXB-241 candidate vaccine induced a neutralising immune response that was superior or equivalent to the pre-fusion stabilised comparator antigens for either RSV or hMPV, including the RSVPreF3 antigen of the licensed RSV vaccine, Arexvy (GSK). The results presented here have supported progression of VXB-241 into a Phase 1 clinical trial which commenced enrolment in August 2024 (ClinicalTrials.gov ID NCT06556147)."

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

RSV OA=ADJ-023: A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above (clinicaltrials.gov) - P2 | N=386 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk (GSK Press Release) - "GSK plc...announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who are at increased risk. GSK’s RSV vaccine is approved in the US for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk....This regulatory submission is supported by a phase IIIb trial evaluating immune response and safety in adults aged 18-49 at increased risk compared to adults aged 60 and above. The safety and reactogenicity data were consistent with results from the phase III programme that supported the initial approval of the vaccine in the US. A regulatory decision by the FDA on this submission is expected in H1 2026."

FDA approval • FDA filing • Respiratory Syncytial Virus Infections

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: Johns Hopkins University

New P2 trial • Respiratory Diseases

Vaccine Development for Human Pneumoviruses. (PubMed, Vaccines (Basel)) - "While significant progress has been made in RSV vaccine development, especially with three approved candidates, the development of vaccines for HMPV remains an unmet medical need. Ongoing research in combination vaccines holds promise for broader protection against multiple respiratory viruses in the future."

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

RSV OA=ADJ=012: An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study (clinicaltrials.gov) - P3 | N=10356 | Recruiting | Sponsor: GlaxoSmithKline | N=15500 ➔ 10356

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

GSK Plc seeks EMA approval for RSV vaccine in adults 18+ (Directors Talk Interviews) - "GSK plc...has announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults from 18 years of age. Arexvy was the first RSV vaccine approved in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk for RSV disease."

EMA filing • Infectious Disease • Respiratory Syncytial Virus Infections

Respiratory Syncytial Virus Prevention in the Adult Population: State of the Art. (PubMed, Semin Respir Crit Care Med) - "This evidence led to recent approval of two subunit vaccines (Arexvy and Abrysvo) and one nucleic acid-based vaccine (mResvia) by regulatory authorities...The coadministration of approved RSV vaccines with seasonal influenza vaccines has been proven to be non-inferior to the immune response from sequential administration. Other vaccines coadministered against different pathogens are currently under investigation."

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

First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults (clinicaltrials.gov) - P1 | N=160 | Completed | Sponsor: Clover Biopharmaceuticals AUS Pty | Recruiting ➔ Completed | N=60 ➔ 160 | Trial primary completion date: Oct 2024 ➔ Feb 2025

Enrollment change • Trial completion • Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults (clinicaltrials.gov) - P1 | N=144 | Active, not recruiting | Sponsor: Vicebio Australia Proprietary Limited | Trial primary completion date: Aug 2025 ➔ Feb 2025

Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above (clinicaltrials.gov) - P3 | N=842 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Neutralizing Antibody Response to the AreXvy Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients: Assessment Against Reference and Seasonal Strains. (PubMed, Vaccines (Basel)) - "Our findings demonstrate a sustained antibody response to the Arexvy® vaccine in a cohort of LTx recipients, with antibody titers sustained over six months. Further research is needed to assess the long-term durability of the immune response and the potential immunogenicity of this vaccine in LTx populations."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Organ Transplantation • Transplantation

Editorial: Surveillance of Seasonal Respiratory Syncytial Virus (RSV) Infection in Children and Vulnerable Adults Drives Vaccine Development and New Immunization Programs. (PubMed, Med Sci Monit) - "There are currently three available RSV vaccines that include an AS01E-adjuvanted RSV prefusion F vaccine (Arexvy), a non-adjuvanted bivalent RSV prefusion F vaccine (Abrysvo), and an mRNA vaccine (MResvia)...The long-acting monoclonal antibody, nirsevimab (Beyfortus), targets the surface F protein of RSV and is effective in late preterm and term infants...Recent modeling and clinical studies have begun to address some of the concerns regarding the safety and efficacy of new RSV vaccines in children, pregnant women, and the elderly. This editorial aims to describe how global surveillance of increasing seasonal RSV respiratory tract infections has driven the development of new vaccines and immunization programs for infants, children, pregnant women, and vulnerable adults."

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

Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Clover Biopharmaceuticals USA, LLC | Not yet recruiting ➔ Recruiting

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

The Potential Public Health Impact of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine Among Older Adults in Italy. (PubMed, Vaccines (Basel)) - " Assuming the target vaccination rate for influenza vaccination in Italy (75%), the model predicted that vaccinating Italian adults ≥75 y and the HR population ≥ 60 y with adjuvanted RSVPreF3 OA would reduce the number of RSV-LRTD events by 43%, leading to a reduction in associated emergency department visits, hospitalizations, complications, deaths, and direct healthcare costs over a 3-year period. The vaccination of Italians aged ≥ 75 y and HR individuals aged ≥ 60 y using the adjuvanted RSVPreF3 OA vaccine has the potential to offer substantial public health benefits by reducing the burden of RSV disease."

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

Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "A single RSVPreF3 OA dose was efficacious against RSV-LRTD over three RSV seasons in people aged 60 years or older, despite a decrease in efficacy over time. Further research is needed to establish the optimal revaccination strategy. These results support the favourable benefit-risk profile of RSVPreF3 OA to help protect against RSV-LRTD for at least three RSV seasons."

Journal • P3 data • Cardiovascular • Heart Failure • Pulmonary Embolism • Respiratory Diseases • Respiratory Syncytial Virus Infections

Arexvy recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices (GSK Press Release) - "GSK plc...is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the use of RSV vaccines including GSK’s Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care. This expands on ACIP’s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older....In making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403]..."

DSMB • Respiratory Syncytial Virus Infections