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RecruitingNCT06597916Updated Nov 27, 2024

RSV Vaccination in Immunocompromised Patients.

A Phase 2 interventional study of Arexvy powder and suspension for injection in RSV Infection, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Medical University of Vienna · Phase 2, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The aim of this study is to assess immunogenicity and safety of the adjuvanted RSV vaccine Arexvy in different cohorts of immunocompromised patients. These data are needed as a basis for RSV vaccine recommendations.

Currently, one dose of the RSV vaccine is recommended for the elderly (≥ 60 years) according to the SmPC and national recommendations. However, it is not clear yet, whether in immunocompromised patients such as those with solid tumors, hemato-oncological malignancies with and without hematopoietic stem cell transplantation (HSCT) or those with biological treatments one dose of RSV vaccine would be sufficient to induce immune responses or if these patients would benefit from a second dose.

It is planned to evaluate immune responses after one and two doses with the adjuvanted RSV vaccine Arexvy in immunocompromised study groups compared to responses of healthy, elderly individuals receiving one vaccine dose only. Our analysis plan will include humoral and cellular immune responses after the first and second dose in immunocompromised patients belonging to different study groups compared to responses after one vaccine dose in controls.

02

Conditions studied

  • RSV Infection

Keywords

  • RSV prophylaxis
  • RSV vaccine
  • RSV vaccination
  • RSV immunocompromised
  • RSV multiple myeloma
  • RSV lung cancer
  • RSV IBD
03

In context

Respiratory Syncytial Virus Infections

293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

General inclusion criteria

  1. Participants who, in the opinion of the investigator, can understand and will comply with the requirements of the protocol.
  2. 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.
  3. Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.
  4. 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
  5. 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.
  6. 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.
  7. Additional inclusion criteria for "group 1":

    7.1. Age ≥18 years at the time of signing the Informed consent form (ICF). 7.2. Diagnosis of a hemato-oncological disease: multiple myeloma including early stage disease or lymphoma in participants medically stable in the opinion of the investigator at study inclusion.

    7.3. Participants without SCT or ≥3 months after autologous SCT until 24 months after SCT. SCT >24 months, if they have ongoing immunomodulatory/suppressive treatment.

    7.4. Immunosuppressive or modulating medication related to the hemato-oncological disease are allowed.

  8. Additional inclusion criteria for "group 2":

    8.1. 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.

  9. Additional inclusion criteria for "group 3":

    9.1. 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).

    9.3. 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).

    9.4. Stable disease at time of study entry.

  10. Additional inclusion criteria for "group 4":

10.1. 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.

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Group 1-3 (2 times verum)

    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

  • Placebo comparator
    Group 4 (1 time verum, 1 time placebo, randomised)

    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

  • BiologicalArexvy powder and suspension for injection

    Arexvy powder and suspension for injection (RSV vaccine)

06

What researchers measure

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.

    Time frame: up to 14 months per participant

07

Study locations

1 of 1 sites recruiting
  • Institute of Specific Prophylaxis and Tropical Medicine, CePII, Medical university of Vienna
    Vienna, 1090, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06597916
Lead sponsor
Medical University of Vienna
Collaborators
GlaxoSmithKline
Responsible party
Angelika Wagner (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 19, 2024
Primary completion
Aug 31, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Nov 27, 2024

Study contacts

Angelika Wagner, MD, PhD
Contact
angelika.wagner@meduniwien.ac.at
+43 1 40160 38276
Ines Zwazl, MSc
Contact
ines.zwazl@meduniwien.ac.at
0043 1 40160 38276

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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