unadjuvanted RSV maternal vaccine (GSK3888550A) / GSK - LARVOL DELTA

Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants. (PubMed, Hum Vaccin Immunother) - P3 | "In this study of high-risk pregnant women, RSVPreF3-Mat demonstrated an acceptable safety profile, induced robust immune responses with successful placental antibody transfer, and showed balanced rates of preterm birth between the groups. Trial registration: EudraCT: 2021-000994-96; NCT: NCT04980391."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • Obstetrics • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Adjuvanted-RSVPreF3 vaccine uptake and effectiveness in individuals with COPD: a nationwide Danish cohort study. (PubMed, Expert Rev Vaccines) - "Adjuvanted-RSVPreF3 is highly effective in preventing RSV hospitalization in individuals aged ≥ 60 years with COPD. Disease outcomes could be improved by incorporating RSV vaccination into routine COPD management."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

224083: A study evaluating persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant (clinicaltrialsregister.eu) - P1/2 | N=71 | Recruiting | Sponsor: GlaxoSmithKline Biologicals

New P1/2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

Immunogenicity and Safety of the AS01E-adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine in Adults Aged 18-49 Years at Increased Risk of RSV Disease Compared with Adults Aged ≥60 Years. (PubMed, Clin Infect Dis) - P3 | "Adjuvanted RSVPreF3 was immunologically noninferior in 18-49-year-olds with underlying conditions compared with ≥60-year-olds in whom efficacy was previously demonstrated, supporting efficacy inference in this younger population. Up to 6 months postvaccination, the vaccine elicited robust immune responses, and the safety profile was acceptable. Clinical Trial Registration: NCT06389487."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4

Serious adverse events and potential immune-mediated diseases following one dose of adjuvanted RSVPreF3 in adults aged ≥18 years: pooled safety analysis from five clinical trials (RSVVW 2026) - P3 | "The reported SAEs and pIMDs were consistent with events anticipated for the studied population predominantly aged ≥60 years with underlying medical conditions. Together with the demonstrated efficacy, the pooled safety data from five phase 3 trials supports a favorable benefit/risk profile of adjuvanted RSVPreF3 in adults aged ≥18 years."

Adverse events • Clinical • Serious adverse event • Immunology • Infectious Disease • Musculoskeletal Diseases • Respiratory Diseases • Respiratory Syncytial Virus Infections

Public Health Impact of Adjuvanted RSVPreF3 Vaccination in Adults Aged 60+ Years in four major metropolitan areas of China: Beijing, Chengdu, Guangzhou and Shanghai (RSVVW 2026) - "Vaccination with adjuvanted RSVPreF3 vaccine avoided RSV-LRTD cases, as well as accompanying HCRU in the form of reduced outpatient visits, ED visits, new antibiotic prescriptions, and hospitalizations, leading to improvements in population health outcome. Funding: GSK (Study ID: 223405)"

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

Adjuvanted RSVPreF3 vaccine effectiveness against RSV-related hospitalization among US adults aged 60 years and older (RSVVW 2026) - "These findings add to the body of real-world evidence highlighting the effectiveness of adjuvanted RSVPreF3 vaccination in preventing RSV-related hospitalization among adults aged ≥60 years, including those at risk due to comorbidities, suggesting that vaccination is an effective strategy in reducing disease burden. Funding: GSK (300153)."

Clinical • Cardiovascular • Diabetes • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Effectiveness of adjuvanted RSVPreF3 vaccine in preventing major adverse cardiovascular events, severe asthma exacerbations, and severe COPD exacerbations among US adults aged 60 years and older (RSVVW 2026) - "Findings suggest a considerable benefit of adjuvanted RSVPreF3 vaccination in preventing RSV-related MACE and severe asthma and COPD exacerbations among adults aged ≥60 years. Funding: GSK (300153)."

Adverse events • Clinical • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Modeled impact of racial and ethnic disparities in RSV vaccination uptake on RSV disease burden averted among US adults aged ≥60 years (RSVVW 2026) - "These findings further highlight the need for improved RSV vaccine implementation, including equitable access to vaccination. Funding: GSK (VEO-001295)."

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness of the Adjuvanted RSV Prefusion F Vaccine in Adults 50–59 at Increased Risk in Italy (RSVVW 2026) - "These findings may be helpful to support policymakers and clinicians in making decisions about RSV vaccination in Italy. Funding: GSK (GSK study identifier: VEO-000942)."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Adjuvanted RSVPreF3 is non-inferior in adults 18–49 years of age (YOA) at increased risk for RSV disease compared to older adults ≥60 YOA: a post-hoc analysis by baseline medical condition (RSVVW 2026) - P3 | "Funding: GSK Acknowledgement: The authors thank RSV OA=Adj-025 study group participants. Medical writing (Maria Maior) and coordination support were provided by Akkodis Belgium c/o GSK."

Clinical • Retrospective data • Respiratory Diseases • Respiratory Syncytial Virus Infections

High-content spectral flow cytometric profiling of RSV prefusion (RSV-PreF3) and postfusion (RSV-PostF) F protein-specific B cells after AS01E-adjuvanted or unadjuvanted RSVPreF3 vaccination (RSVVW 2026) - P1/2 | "This work demonstrates that RSV-PreF3 specific B cells dynamically respond to AS01E-adjuvanted RSVPreF3 and unadjuvanted RSVPreF3 vaccination, including those that cross-react with RSV-PostF, in all vaccine groups. Funding: GSK"

Clinical • Respiratory Syncytial Virus Infections • CD21 • CD27 • TFRC

Real-World Evidence of the Adjuvanted-RSVPreF3 Vaccine's Uptake and Effectiveness among Chronic Obstructive Pulmonary Disease Patients in Denmark: A Nationwide Cohort Study (RSVVW 2026) - "Among adults aged ≥60 with COPD, adjuvanted-RSVPreF3 is highly effective in preventing RSV hospitalizations and RSV-related clinical outcomes such as exacerbations and pneumonias. Incorporating the RSV vaccine into routine COPD management could further improve outcomes."

Clinical • HEOR • Real-world • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Unlocking the Value of RSV Adult Vaccination with adjuvanted RSVPreF3 Vaccine in Italy: a Return on Investment Analysis Using an Integrated Actuarial-Macroeconomic Model (RSVVW 2026) - "These findings provide robust evidence to support policy decisions for public investment in RSV immunisation as a valuable preventive strategy. Funding: GSK (GSK study identifier: VEO-001370)."

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

Cost-effectiveness of the adjuvanted respiratory syncytial virus prefusion F protein (RSVPreF3) vaccine in Japanese adults aged 50-59 years at increased risk of severe RSV disease and those aged ≥60 years. (PubMed, Expert Rev Vaccines) - P3 | "Scenario and sensitivity analyses results were robust. RSV vaccination may provide substantial health benefits and be a cost-effective intervention to reduce RSV burden in adults in Japan."

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-effectiveness of a single dose of the adjuvanted RSVPreF3 vaccine for the prevention of respiratory syncytial virus (RSV) among patients with chronic obstructive pulmonary disease in Italy. (PubMed, Expert Rev Vaccines) - "The incremental cost-effectiveness ratio (health system perspective) was €1,306/QALY. These results indicated that a single dose of adjuvanted RSVPreF3 vaccine in patients with COPD aged 60-74 years in Italy is a cost-effective preventive option that could potentially reduce RSV-related disease burden and costs over five years."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Reply to letter to editor "public health impact and cost-effectiveness of the adjuvanted RSVPreF3 vaccine for respiratory syncytial virus prevention among adults aged 50 years and older in Germany". (PubMed, Expert Rev Vaccines) - No abstract available

HEOR • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

Enrollment open • Respiratory Diseases

Unlocking the Value of RSV Adult Vaccination With Adjuvanted RSVpreF3 Vaccine in Germany: A Return on Investment Analysis Using an Integrated Actuarial-Macroeconomic Model (ISPOR-EU 2025) - "A vaccination programme with the adjuvanted RSVPreF3 vaccine in Germany would constitute a high-value public health investment, yielding positive returns. The results support informed decisions on public investment in RSV immunisation as a cost-saving strategy that delivers both substantial health benefits and economic gains."

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

Adjuvanted RSVpreF3 Vaccine for Respiratory Syncytial Virus Prevention in the United Kingdom, Spain, and Australia: A Climate Change Impact Analysis (ISPOR-EU 2025) - "A single-dose adjuvanted RSVPreF3 vaccination programme for OA aged ≥60 years in the UK could reduce the CO2e emissions associated with RSV treatment and management over 5 years, suggesting that RSV vaccination improves public health and healthcare-related climate change impact. This evidence may inform policymakers and payers of the wider societal benefits of implementing RSV prevention programmes. Broader environmental considerations, such as human health impacts, water footprint and antimicrobial resistance mitigation, will be crucial for planetary stability."

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections

Unlocking the Value of RSV Adult Vaccination With Adjuvanted RSVpreF3 Vaccine in Spain: A Return on Investment Analysis Using an Integrated Actuarial Macroeconomic Model (ISPOR-EU 2025) - "From a societal perspective a vaccination programme with the adjuvanted RSVPreF3 vaccine in Spain would constitute a high-value public health investment, yielding positive returns. The results support informed decisions on public investment in RSV immunisation as a cost-saving strategy that delivers both substantial health benefits and economic gains."

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

Immune persistence and safety of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial. (PubMed, Hum Vaccin Immunother) - P3 | "In conclusion, adjuvanted RSVPreF3 induced a humoral and cell-mediated immune response persisting until at least 12 months post-vaccination in adults 50-59 YOA, including those at increased risk for RSV disease. The vaccine had an acceptable 12-month safety profile in adults 50-59 YOA, consistent with that in adults ≥60 YOA.Trial Registration: ClinicalTrials.gov: NCT05590403."

Clinical • Journal • Hematological Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4

Public Health Impact and Cost-Effectiveness of Adjuvanted RSVPreF3 Vaccination among Adults in the USA Aged 50-59 Years at Increased Risk of Severe RSV Disease. (PubMed, Infect Dis Ther) - "In US adults aged 50-59 years at increased risk of severe RSV, a single dose of adjuvanted RSVPreF3 vaccination was projected to improve public health outcomes at a lower societal cost compared with no vaccination. Efforts are needed to ensure access to vaccination for populations at increased risk of severe RSV disease."

HEOR • Journal • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Heart Failure • Immunology • Infectious Disease • Influenza • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant (clinicaltrials.gov) - P2 | N=234 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2027 ➔ Jul 2027

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

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant (clinicaltrials.gov) - P2 | N=234 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation