Safety and immunologic response of SHIngrix VAccination in patients suffering from Psoriasis or Psoriatic arthritis
Key facts
- Where
- Bad Bentheim, Bonn, Frankfurt Am Main, Freiburg im Breisgau, Hamburg, Hanover, Marburg, Merzig, Muenster, Munich, Straubing, Wetzlar és Wuppertal, NémetországSee the 16 sites
- Phase
- 4. fázis
Where in Németország
- Thermalsole und Schwefelbad Bentheim GmbHBad Bentheim, NémetországTaking people
- Universitaetsklinikum Bonn AöRBonn, NémetországTaking people
- Goethe University FrankfurtFrankfurt Am Main, NémetországTaking people
- Infektio Research GmbH & Co. KGFrankfurt Am Main, NémetországTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországTaking people
- ICH Study Center Gmbh & Co. KGHamburg, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Rheumatologische Praxis Hannover GbRHanover, NémetországTaking people
- Philipps-Universitaet MarburgMarburg, NémetországTaking people
- Hms GmbHMerzig, NémetországTaking people
- Universitaet MuensterMuenster, NémetországTaking people
- Universitaetsklinikum Muenster AöRMuenster, NémetországTaking people
- Klinikum der Universitaet Muenchen AöRMunich, NémetországTaking people
- Barmherzige Brueder gemeinnuetzige Traeger GmbHStraubing, NémetországTaking people
- Studienteam Lahn-Dill-Siegerland GbRWetzlar, NémetországTaking people
- Klinikverbund St. Antonius und St. Josef GmbHWuppertal, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Justus-Liebig-Universitaet Giessen
- Trial code
- EU 2024-512881-32-00
- Record updated
- 2026. április 30.
- Original description
To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.Read full original descriptionShow less
Safety and immunogenicity of Shingrix vaccination in patients suffering from Psoriasis or Psoriatic arthritis
To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.
Inclusion: Diagnosis of psoriasis vulgaris and/or psoriatic arthritis; Score thresholds depending on disease: a. PASI ≤ 9 and DAPSA ≤ 14 in patients having both psoriasis and psoriasis arthritis b. PASI ≤ 9 in patients presenting with psoriasis vulgaris only c. DAPSA ≤ 14 in patients presenting with psoriasis arthritis without major skin involvement; Age ≥ 18 and ≤ 75 years; Written informed consent; Women of childbearing potential should use at least one of the following contraceptive measures up until 2 months after the second vaccination (week 24 of the study): - progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action - male or female condom with or without spermicide - cap, diaphragm or sponge with spermicide.
Exclusion: Concurrent participation in another interventional AMG trial; Prior administration of recombinant zoster vaccine (RZV) at any point in time, or any other herpes zoster or varicella vaccine received less than12 months ago; Previous or current history of HZ; Live virus and mRNA vaccines cannot be administered within 30 days (before/after) RZV and inactivated/ subunit vaccines within 8 days (before/after) RZV; Patients with disease flares within the past 6 months. A disease flare is defined as any therapeutic escalation during the past 6 months prior to screening. This includes new onset of concomitant immunomodulation, change of ongoing immunomodulation, and/or use of glucocorticoids ≥ 10 mg per day prednisolone equivalent; History of chronic infectious disease; Past or current history of cancer not curatively treated. Curatively treated malignancies must be without evidence of disease for a minimumof 5 years upon enrollment; Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere withcompletion of the study; Hypersensitivity to the active substance or to any of the other substance of Shingrix; Subject pregnant or breast feeding.