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

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."

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."

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

Structural interrogation of a trimeric prefusion RSV fusion protein vaccine candidate by a camelid nanobody. (PubMed, Vaccine) - "Moreover, the binding kinetics of F-VHH-L66 to RSVPreF3 are comparable to those of AM14 when measured by surface plasmon resonance (SPR). Finally, F-VHH-L66 neutralized RSV(A) with similar efficacy as AM14; this bioactivity data further supports its use as an alternative to AM14 for pre-fusion specific structural characterization of RSVPreF3."

Journal • Oncology • 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=4129 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • 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. (clinicaltrialsregister.eu) - P3 | N=5343 | Sponsor: GlaxoSmithKline Biologicals SA

New P3 trial • Respiratory Syncytial Virus Infections

A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women. (clinicaltrials.gov) - P3 | N=1542 | Completed | Sponsor: GlaxoSmithKline | Trial primary completion date: Jan 2022 ➔ Jun 2022

Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and immunogenicity of an investigational respiratory syncytial virus vaccine (RSVPreF3) in mothers and their infants: a phase 2 randomized trial. (PubMed, J Infect Dis) - P2 | "RSVPreF3 maternal vaccination had an acceptable safety risk profile and induced robust RSV-specific immune responses with successful antibody transfer to their newborns."

Clinical • Journal • P2 data • Respiratory Diseases • Respiratory Syncytial Virus Infections