Respiratory syncytial virus, glycoprotein F, recombinant, stabilised in the pre-fusion conformation, adjuvanted with AS01E for Respiratory syncytial virus infection

Inclusion criteria

• {"criterion_text":"- Participants who, in the opinion of the investigator, can understand and will comply with the requirements of the protocol.\n- Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.\n- Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception as described in chapter 6.5.1. from 1 month prior to first Arexvy vaccination and agreed to continue adequate contraception for at least 1 month after completion of the last study intervention administration, and has a negative pregnancy test on the day of first vaccination prior to vaccine application.\n- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, and post-menopause.\n- Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.\n- Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable."}

Exclusion criteria

• {"criterion_text":"- Previous RSV vaccination, including investigational RSV vaccines.\n- Pregnant or lactating female participant.\n- Female participant planning to become pregnant or planning to discontinue contraceptive precautions.\n- History of ongoing chronic alcohol consumption and/or drug abuse.\n- Participation of any study personnel or their immediate dependents.\n- Any history of dementia or any medical condition that moderately or severely impairs cognition\n- Expected unavailability for the planned study visits.\n- Administration of immunoglobulins and/or any blood products or plasma derivatives within three months before first dose of Arexvy) and during the entire study participation.\n- A confirmed or suspected primary immunodeficiency disease or HIV infection.\n- Evidence or high suspicion, in the opinion of the investigator, of non-compliance or non-adherence to the use of induction and/or maintenance immunosuppressive therapies.\n- Known hypersensitivity to a component of the study vaccine (Arexvy).\n- Acute infection and/or fever at the time of study vaccine administration (>=38°C oral, tympanic or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator.\n- Acute or chronic clinically significant/unstable disease of the cardiovascular, renal, hepatic or neurological organ system (such as hemodialysis, liver cirrhosis (Child-Pugh class C), uncontrolled seizures etc.).\n- Significant underlying illness that would prevent completion of the study.\n- Contraindication for i. m. injection.\n- Use of any other investigational or non-registered product (drug, vaccine, or medical device) less than 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period / participation (up to 12 months after last vaccination).\n- Concurrently participating in another active clinical study that includes the application of investigational products (medication, vaccine, medical devices).\n- Participant received other vaccinations starting from 30 days prior to the first dose and ending 30 days after the last dose. For COVID-19 and influenza vaccines a 14 day interval applies."}

Primary endpoints

• {"endpoint_text":"- Fold increase of RSV-A and -B-specific neutralizing titers 30-60 days (V5) after the second dose relative to titers 30-60 days (V3) after the first dose in immunocompromised patients. Analysis will be performed by group and on the pooled immunocompromised patient.","definition_or_measurement_approach":"Measurement of RSV-A and RSV-B neutralizing antibody titers at 30-60 days after first dose (V3) and 30-60 days after second dose (V5); primary endpoint is the fold increase in neutralizing titers (V5 vs V3). Analyses performed by group and pooled across immunocompromised patients."}

Secondary endpoints

• {"endpoint_text":"- RSV-A and -B-specific neutralizing antibody (NT) and PreF3-specific IgG (ELISA) levels from baseline to up to 12 months post last dose by group and on the pooled immunocompromised patients and in controls.","definition_or_measurement_approach":"Quantification of NT and PreF3-specific IgG (ELISA) from baseline through up to 12 months post last dose by group and pooled; comparison with controls."}
• {"endpoint_text":"- RSV-A and -B-specific neutralizing antibody (NT) and PreF3-specific IgG (ELISA) increase above baseline (V1) at all visits (V2-V7) by group and on the pooled immunocompromised patients and in controls.","definition_or_measurement_approach":"Assess increases in NT and PreF3-specific IgG levels above baseline at visits V2–V7 by group and pooled; measured by NT assays and ELISA."}
• {"endpoint_text":"- Seroresponse rate (increase in NT/IgG ELISA) of participants per group at all post-first dose visits over baseline by group and on the pooled immunocompromised patients and in controls.","definition_or_measurement_approach":"Determine seroresponse rates defined by increases in NT and IgG ELISA at post-first dose visits compared to baseline, by group and pooled."}
• {"endpoint_text":"- Antibody decline (NT/IgG ELISA) after first and second dose of Arexvy in immunocompromised patients by group and on the pooled immunocompromised patients and in controls.","definition_or_measurement_approach":"Measure decline kinetics of NT and IgG ELISA after doses over follow-up up to 12 months; comparisons by group and pooled."}
• {"endpoint_text":"- Antibody decline (NT/IgG ELISA) after one dose of Arexvy the healthy control group ≥60 YoA.","definition_or_measurement_approach":"Measure antibody waning in healthy control group (≥60 years) after one dose using NT and IgG ELISA up to 12 months."}
• {"endpoint_text":"- RSV-A and -B-specific neutralizing antibody (NT) and PreF3-specific IgG (ELISA) from baseline to 12 months post last dose in immunocompromised patients by group and on the pooled immunocompromised patients and in controls and compared to controls.","definition_or_measurement_approach":"Longitudinal measurement of NT and PreF3 IgG from baseline to 12 months post last dose; comparisons between immunocompromised groups (by group and pooled) and controls."}
• {"endpoint_text":"- RSV-A and -B-specific neutralizing antibodies and PreF3-specific IgG (ELISA) antibody decline after second dose in immunocompromised patients per group and pooled compared to decline in controls after first dose up to 12 months post last dose.","definition_or_measurement_approach":"Compare antibody decline after second dose in immunocompromised patients to decline after first dose in controls over 12 months using NT and ELISA."}
• {"endpoint_text":"- Cytokine production after RSV PreF3-specific PBMC restimulation such as IFN-g and IL-2 (V1-V7) in immunocompromised patients per group and controls.","definition_or_measurement_approach":"Measure cytokine production (e.g., IFN-γ, IL-2) from PBMC restimulation assays at visits V1–V7; analyses by group and in controls."}
• {"endpoint_text":"- Participants reporting solicited local and systemic AEs (up to 7 days post V1 and V3)","definition_or_measurement_approach":"Collection of solicited local and systemic adverse events reported by participants up to 7 days after V1 and V3 (standard solicited AE diary/collection)."}
• {"endpoint_text":"- Participants reporting unsolicited (up to 30 days post V1 and V3) adverse events","definition_or_measurement_approach":"Collection of unsolicited adverse events reported up to 30 days after V1 and V3."}
• {"endpoint_text":"- Participants reporting SAEs, and AEs of special interest (atrial fibrillation, pIMD) from patient notification during the whole study period.","definition_or_measurement_approach":"Recording of SAEs and AEs of special interest (atrial fibrillation, potential immune-mediated diseases) reported by participants throughout study period."}
• {"endpoint_text":"- Cases of death after application of the first dose up to 12 months post last dose.","definition_or_measurement_approach":"Recording and reporting of deaths occurring from first dose through 12 months after last dose."}

Methods

• Recruitment arrangements and materials (document titles indicate use of recruitment flyer text).
• Recruitment material short text (brief text for outreach).
• Recruitment material text for self-help groups (targeting self-help/support groups).
• Recruitment material flyer text specialists (materials aimed at specialist clinicians).

Austria

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

14-07-2025

Processing Time Days

347

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria