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

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

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

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

Design of a peptide-based vaccine against human respiratory syncytial virus using a reverse vaccinology approach: evaluation of immunogenicity, antigenicity, allergenicity, and toxicity. (PubMed, Front Immunol) - "Attempts to develop an hRSV vaccine have faced safety and efficacy challenges, with only three FDA-approved vaccines (Moderna's Mresvia, Pfizer's Abrysvo, and GSK's Arexvy) available...We then characterized its kinetic properties, evaluated its structural integrity, and analyzed its interactions with Toll-like receptors (TLRs) using molecular docking, modeling, and refinement with AlphaFold3 and ClusPro...This study presents a promising peptide-based vaccine candidate against hRSV that can effectively engage the immune system, showing strong immunogenicity and antigenicity. Future in vitro and in vivo studies are essential to evaluate the ability of the multi-epitope vaccine candidate to stimulate both humoral and cell-mediated immune responses and to assess its efficacy and safety profile."

Journal • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNG • IL2 • TLR1 • TLR4

Development and evaluation of ELISA serological immunoassays for influenza and respiratory syncytial viruses. (PubMed, Diagn Microbiol Infect Dis) - "These ELISA assays are scalable tools for seroepidemiological and maternal transfer studies. Future work will include correlation with neutralizing antibodies and paired maternal-infant analyses."

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

New developments in the prevention and management of RSV in 2025 (PubMed, Rev Med Suisse) - "Prevention has advanced with the introduction of vaccines such as Arexvy and Abrysvo, as well as nirsevimab for infants. These innovations are expected to significantly reduce the burden of RSV in the coming years."

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

Immunogenicity of RSV Vaccination in Thoracic-Organ Transplantation (ISHLT 2025) - "This study evaluated the immunogenicity of two RSV vaccines, Arexvy and Abrysvo, in this population.Methods This was a prospective, single-center study among transplant recipients and healthy controls eligible for the RSV vaccine...Univariate analyses found age and mycophenolate mofetil negatively associated with increased Ab titers (p<0.05), while vaccine, organ type and time from transplant were not...Most thoracic transplant recipients mounted a robust response to the RSV vaccine that was durable over a 3-month period. Presuming that the humoral and cellular responses measured relate to protection, its duration may inform the need for additional vaccine doses in this population."

Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation • CD4 • CD8

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above (clinicaltrials.gov) - P3 | N=1459 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

HUMORAL AND CELLULAR IMMUNE RESPONSE TO ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS VACCINE RSVPREF3 IN ADULTS AFTER ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (EBMT 2025) - "Vaccination with Arexvy is well tolerated in patients following allogeneic HCT. However, preliminary findings indicate that a single dose may elicit an insufficient immune response in many patients. Final results will help guide future vaccination strategies for this particularly vulnerable patient population."

Clinical • Fatigue • Graft versus Host Disease • Immunology • Musculoskeletal Pain • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

RSV Prefusion F3 Vaccine in Lung Transplant Recipients elicits CD4+ T-cell response in all Vaccinees. (PubMed, Am J Transplant) - "The immunogenicity of the novel RSV Prefusion F3 (RSVPreF3-AS01, Arexvy, GlaxoSmithKline) vaccine in immunocompromised patients remains largely unknown...These results suggest that some patients may derive clinical benefit from the vaccine through cellular immunity, even without an antibody response. Furthermore, the vaccine was well tolerated in this vulnerable population, with no major safety concerns observed."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplant Rejection • Transplantation • CD4

Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three RSV seasons: a randomized trial (ESCMID Global 2025) - "Organised by The Lancet group"

Clinical • Late-breaking abstract • Respiratory Diseases • Respiratory Syncytial Virus Infections

Development, Current Status, and Remaining Challenges for Respiratory Syncytial Virus Vaccines. (PubMed, Vaccines (Basel)) - "Two protein subunit vaccines (GSK's Arexvy and Pfizer's Abrysvo) and one mRNA RSV vaccine (Moderna's mRESVIA) are now available...Furthermore, ongoing vaccine surveillance and further evaluation, particularly among immunocompromised patients, frail elderly subjects, and young infants that were under- or not represented in pivotal clinical trials, are necessary. As in the success story of combined pediatric vaccines, combination vaccines, conferring protection against several respiratory illnesses in one dose, could help improve vaccine acceptance and coverage rates in older adults."

Journal • Review • Geriatric Disorders • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

New P1 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

In brief: New warning for the RSV vaccines Arexvy and Abrysvo. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hematological Malignancies • Leukemia • Oncology • Respiratory Syncytial Virus Infections

2024 Adoption Rates of RSV Preventative Measures in Infants, Pregnant Mothers, and the Elderly. (AAAAI-WAO 2025) - "Percentages of eligible infants receiving Nirsevimab, of pregnant mothers receiving Abrysvo and of elderly patients receiving Arexvy, MResvia and Abrysvo were extracted...Cases of RSV in patients who received prevention were low. Overall low rates of vaccination indicate a crucial need to increase awareness of RSV prevention among healthcare workers."

Clinical • Late-breaking abstract • 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 | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections