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NCT06597916
RSV Vaccination in Immunocompromised Patients.
Phase 2 trial testing Arexvy powder and suspension for injection in RSV Infection in 200 participants. Currently enrolling.
31 August 2025
Quick facts
| Lead sponsor | Medical University of Vienna |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 200 |
| Start date | 19 September 2024 |
| Primary completion | 31 August 2025 |
| Estimated completion | 31 March 2026 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Arexvy powder and suspension for injection — full drug profile →
Conditions studied
- RSV Infection — all drugs for RSV Infection →
Sponsor
Medical University of Vienna
Who can join
18 and older, any sex, with RSV Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control.
Shi J, Huang X, Ye C, Lu Y, et al · · 2026 · PMID 41261734 · DOI 10.1002/med.70025
Verify or expand the search:
- PubMed search for NCT06597916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for RSV Infection
Currently open trials in the same condition.
- NCT06881953 — Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France · recruiting
- NCT06866405 — A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Sin · Phase 3 · recruiting
- NCT06843317 — Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults · Phase 1 · recruiting
- NCT06172660 — Real-World Effectiveness of Perinatal RSV Immunoprophylaxis · recruiting
- NCT06640387 — CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools · recruiting
Other Medical University of Vienna trials
Trials by the same sponsor.
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- NCT07511400 — The Role of NaV1.8 in Human Pain Models · EARLY_PHASE1 · not yet recruiting
- NCT07516990 — Intramuscular Injection of Mashed Parathyroid Tissue Into a Forearm During Thyroid Surgery to Prevent Permanent Postoper · NA · recruiting
- NCT07496437 — Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation? · NA · not yet recruiting
- NCT07290712 — Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06597916 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Vienna
- Last refreshed: 27 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06597916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing