RSV Vaccination in Immunocompromised Patients.

NCT06597916 | Recruiting Phase 2 DMC

• 1 other identifier: ISPTM-RSV-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory syncytial Virus (RSV) causes respiratory infections worldwide and typically presents with a seasonal pattern peaking in autumn/winter in temperate climate zones. Apart from infants and elderly individuals, patients with underlying substantial respiratory, cardiovascular, endocrinological diseases and immunocompromised patients are at increased risk to develop lower respiratory tract infection (LRTI) requiring intensive care associated with increased mortality. For certain risk groups such as patients after hematologic stem cell transplantation (HSCT) in-hospital mortality may be as high as 70 %. A causally related, RSV specific treatment does not exist and treatment is therefore usually supportive and non-specific. The study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose. The additional dose will be administered off label.

Conditions

RSV Infection

Keywords

RSV prophylaxis; RSV vaccine; RSV vaccination; RSV immunocompromised; RSV multiple myeloma; RSV lung cancer; RSV IBD

Outcome Measures

Primary Outcomes (1)

• To assess the mean geometric increase of RSV-A and RSV-B neutralizing antibodies after second vaccine dose over first vaccine dose with the adjuvanted RSV subunit vaccine Arexvy in immunocompromised patients ≥ 18 YoA.

  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 per group.

  up to 14 months per participant

Study Arms (2)

Group 1-3 (2 times verum)

EXPERIMENTAL

Group 1-3 receive 2 doses of the RSV vaccine at visit 1 and visit 3, 1-2 months apart.

Biological: Arexvy powder and suspension for injection

Group 4 (1 time verum, 1 time placebo, randomised)

PLACEBO COMPARATOR

Group 4 receives 1 doses of the RSV vaccine or placebo at visit 1 and visit 3.

Biological: Arexvy powder and suspension for injection

Interventions

Arexvy powder and suspension for injection BIOLOGICAL

Arexvy powder and suspension for injection (RSV vaccine)

Group 1-3 (2 times verum); Group 4 (1 time verum, 1 time placebo, randomised)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who, in the opinion of the investigator, can understand and will comply with the requirements of the protocol.
• 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.
• Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, post-menopause, premenarche, bilateral oophorectomy, or bilateral salpingectomy
• Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception 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.
• 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.
• Participants without SCT or ≥3 months after autologous SCT until 24 months after SCT. SCT \>24 months, if they have ongoing immunomodulatory/suppressive treatment.
• Immunosuppressive or modulating medication related to the hemato-oncological disease are allowed.
• Age ≥18 years at the time of signing the Informed consent form (ICF). 8.2. Diagnosis of lung cancer ≥ stage 1. 8.3. Ongoing cancer treatment (including chemotherapy and immunotherapy) or initiation planned within 14 days and treatment initiation/vaccinations preferentially scheduled between treatment cycles.
• Age ≥18 years at the time of signing the Informed consent form (ICF). 9.2. Diagnosis of an autoimmune/chronic inflammatory disease with chronic inflammatory bowel disease (IBD) or rheumatoid arthritis (RA).
• Treatment with biologicals such as TNF-alpha blocker, anti-CD20, JAK-inhibitors or other biological treatment (combinations with DMARDs, immunomodulators or steroidal or non-steroidal anti-inflammatory drugs are allowed).
• Stable disease at time of study entry.
• Age ≥60 years at the time of signing the Informed consent form (ICF). 10.2. Healthy, as established by medical history before entering the study with medically stable/controlled chronic conditions such as diabetes, hypertension or cardiac disease allowed.

Sponsors & Collaborators

• Medical University of Vienna: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Institute of Specific Prophylaxis and Tropical Medicine, CePII, Medical university of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Suspensions; Injections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Angelika Wagner, MD, PhD

CONTACT

+43 1 40160 38276; angelika.wagner@meduniwien.ac.at

Ines Zwazl, MSc

CONTACT

0043 1 40160 38276; ines.zwazl@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Controls will be randomized in a 1:1 ratio before study intervention at V1 to receive Arexvy / saline.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, single-center, parallel group, controlled, phase-2b

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: September 19, 2024
• Primary Completion: August 31, 2025
• Study Completion: March 31, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)