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

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

RSV vaccination uptake among adults aged 60 years and older in the United States during the 2023-2025 vaccination seasons. (PubMed, Hum Vaccin Immunother) - "Despite the increased risk of severe RSV disease among older adults and those with certain risk factors, relatively limited RSV vaccination uptake was observed during the 2023-2025 seasons, with disparities observed. Additional efforts are needed to support RSV prevention among those at highest risk and to ensure equitable access to vaccination."

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

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) - "RSV vaccination is cost-effective versus no vaccination (<€50,000 willingness-to-pay threshold): incremental cost-effectiveness ratios were €19,789, €19,631, and €12,733 for strategies 1, 2 and 3, respectively; 1.6, 1.4, and 0.8 million outpatient visits and 192,402, 185,238, and 152,781 hospitalizations could be prevented with strategies 1, 2, and 3, respectively. Expanding RSV vaccination to a larger target population would prevent more RSV cases, though at a higher cost per case averted; all vaccination strategies would be deemed cost-effective in Germany."

HEOR • Journal • Geriatric Disorders • Respiratory Diseases • 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

Potential public health impact of the adjuvanted RSVPreF3 vaccine in adults aged 60 years and older: results from a modeling study in India and Southeast Asia. (PubMed, Expert Rev Vaccines) - "Adjuvanted RSVPreF3 vaccination with a 30% coverage could prevent 8.6 million RSV ARI, 460,255 hospitalizations, 423,659 pneumonia, and 43,693 deaths over five years. The projected burden of RSV was substantial in India and Southeast Asia, and could greatly be alleviated through adjuvanted RSVPreF3 vaccination of adults ≥60 years."

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

Public Health Impact and Cost-Effectiveness of Adjuvanted RSVPreF3 Vaccination in US Adults Aged 60 Years with Cardiopulmonary Disease (ISPOR 2025) - "Adjuvanted RSVPreF3 vaccination among adults ≥60 YOA with cardiopulmonary disease was projected to reduce both RSV disease burden and societal costs. However, achieving these outcomes in real-world practice would require efforts to improve RSV vaccination uptake. Funding: GSK (VEO-000319)."

Clinical • Cost effectiveness • HEOR • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Immunology • Infectious Disease • Influenza • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Estimated Public Health Impact of Adjuvanted RSVPreF3 Vaccination in US Adults Aged 18-49 Years Who Are at Increased Risk for Severe RSV Disease (ISPOR 2025) - "Results suggest substantial potential public health benefits of adjuvanted RSVPreF3 vaccination in adults 18-49 YOA at increased risk of severe RSV disease. Future analyses may further inform the potential value of adjuvanted RSVPreF3 vaccination in this population. Funding: GSK (VEO-001040)."

Clinical • Asthma • Diabetes • Immunology • Infectious Disease • Influenza • Metabolic Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control (clinicaltrials.gov) - P3 | N=3962 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed | Phase classification: P3b ➔ P3

Phase classification • Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Efficacy, immunogenicity, and safety of an investigational maternal respiratory syncytial virus prefusion F protein-based vaccine. (PubMed, Clin Infect Dis) - P3 | "Consistent with the high titers of transplacentally transferred antibodies, this trial suggests a reduced risk of any/severe MA-RSV-LRTD and RSV hospitalization until 6 months post-birth in infants born to mothers immunized with RSVPreF3-Mat during pregnancy. However, vaccine development was terminated due to an identified preterm birth risk."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-effectiveness of the adjuvanted RSVPreF3 vaccine among adults aged ≥60 years in the United States. (PubMed, Hum Vaccin Immunother) - "From the societal perspective, adjuvanted RSVPreF3 vaccination resulted in an ICER of $18,430 per QALY gained. Results were relatively robust across sensitivity analyses and indicate that adjuvanted RSVPreF3 vaccination is a cost-effective option for the prevention of RSV in US adults aged ≥ 60 years, reducing the substantial burden within this population."

Cost effectiveness • HEOR • Journal • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Modeling Respiratory Syncytial Virus Burden and Public Health Impact of RSVPreF3 Vaccine Among Adults Aged ≥60 Years Old in Five Countries in South East Asia (ISPOR-EU 2024) - P3 | "RSV public health burden in older adults’ population is significant. The introduction of the adjuvanted RSVPreF3 is projected to substantially reduce this burden among elderly in SE Asia. Adjuvanted RSVPreF3 immunization also shows promise to improve public health outcomes mitigating morbidity and mortality associated with RSV infections in this population."

Clinical • Infectious Disease • Pneumonia • 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 (ISPOR-EU 2024) - "A vaccination program using one dose of the adjuvanted RSVPreF3 vaccine in the population ≥75y and ≥60y HR, offers the potential for substantial reductions of disease burden associated with RSV in and HR OA in Italy, and potential reductions in direct costs for the Italian National Health Service. These findings may be helpful to support policymakers and clinicians in making decisions about RSV vaccination in Italy. Funding: GSK (GSK study identifier: VEO-000627)."

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

Phase 3 Study Assessing Lot-to-lot Consistency of RSVPreF3 Vaccine and its Immune Response, Safety, and Reactogenicity When Co-administered with FLU-D-QIV. (PubMed, J Infect Dis) - P3 | "Immunogenic consistency was demonstrated for 3 separate lots of RSVPreF3. Immunogenic noninferiority was demonstrated when comparing FLU-D-QIV administered alone, versus co-administered with RSVPreF3, for 3 strains of FLU-D-QIV. Co-administration was well tolerated, and both vaccines had clinically acceptable safety and reactogenicity profiles."

Clinical • Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness of Adjuvanted RSVPreF3 Vaccination in Adults Aged 50-59 Years With Cardiopulmonary Diseases in the United States (ISPOR 2024) - "Adjuvanted RSVPreF3 vaccination is cost-effective for the prevention of RSV in adults 50-59 YOA with the modeled cardiopulmonary diseases, representing an efficient use of healthcare resources. Funding: GlaxoSmithKline Biologicals SA(VEO-000556)"

Clinical • Cost effectiveness • HEOR • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Immunology • Infectious Disease • Influenza • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Public Health Impact of the Adjuvanted RSVPreF3 Vaccine for Respiratory Syncytial Virus Prevention Among Older Adults in the United States. (PubMed, Infect Dis Ther) - "These findings highlight the potential of the adjuvanted RSVPreF3 vaccine to substantially reduce RSV disease burden among US older adults aged ≥ 60 years."

Journal • Geriatric Disorders • Infectious Disease • Influenza • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV Prefusion F Protein-Based Maternal Vaccine - Preterm Birth and Other Outcomes. (PubMed, N Engl J Med) - P3 | "The results of this trial, in which enrollment was stopped early because of safety concerns, suggest that the risks of any and severe medically assessed RSV-associated lower respiratory tract disease among infants were lower with the candidate maternal RSV vaccine than with placebo but that the risk of preterm birth was higher with the candidate vaccine. (Funded by GlaxoSmithKline Biologicals; ClinicalTrials.gov number, NCT04605159.)."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers (clinicaltrials.gov) - P3 | N=384 | Terminated | Sponsor: GlaxoSmithKline | Completed ➔ Terminated; Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.

Trial termination • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

GRACE: A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers (clinicaltrials.gov) - P3 | N=10578 | Terminated | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Terminated; Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.

Trial termination • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of Respiratory Syncytial Virus Pre-fusion Maternal Vaccine Co-administered with Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study. (PubMed, J Infect Dis) - P2 | "This study indicates RSVPreF3 co-administration with dTpa induces robust immune responses and is well tolerated, regardless of the RSVPreF3 dose level used."

Clinical • Journal • P2 data • Infectious Disease • Pain • Pertussis • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. (PubMed, NPJ Vaccines) - "In primed bovines, RSVPreF3/AS01 tended to induce higher pre-/post-vaccination fold-increases in RSV-A/B-specific neutralization titers relative to non-adjuvanted and Alum-adjuvanted RSVPreF3 formulations, and elicited higher RSV F-specific CD4 T cell frequencies relative to the non-adjuvanted vaccine. Though AS01 adjuvanticity varied by animal species and priming status, RSVPreF3/AS01 elicited/boosted RSV-A/B-specific neutralization titers and RSV F-specific CD4 T cell responses in both animal models, which supported its further clinical evaluation as prophylactic candidate vaccine for older adults."

Journal • Preclinical • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4

Safety and Reactogenicity of an Unadjuvanted Maternal Respiratory Syncytial Virus (RSV) Prefusion F Protein-Based Vaccine (RSVPreF3-Mat): Interim Analysis up to 6 Months Post-Delivery/Birth (ESWI 2023) - No abstract available

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections

Efficacy of an Unadjuvanted Maternal Respiratory Syncytial Virus (RSV) Prefusion F Protein-Based Vaccine (RSVPreF3-Mat) in Infants: Interim Analysis up to 6 Months Post-Birth (ESWI 2023) - No abstract available

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

A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control (clinicaltrials.gov) - P3b | N=4129 | Recruiting | Sponsor: GlaxoSmithKline | Phase classification: P3 ➔ P3b

Phase classification • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

The RSVPreF3-AS01 vaccine elicits broad neutralization of contemporary and antigenically distant respiratory syncytial virus strains. (PubMed, Sci Transl Med) - "RSV-neutralizing responses are thought to play a central role in preventing RSV infection. Therefore, the breadth of RSVPreF3-AS01-elicited neutralization responses may contribute to vaccine efficacy against contemporary RSV strains and those that may emerge in the future."

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

A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers (clinicaltrials.gov) - P3 | N=367 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

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