2024-512881-32-00RecruitingPhase 4
Safety and immunologic response of SHIngrix VAccination in patients suffering from Psoriasis or Psoriatic arthritis
Safety and immunogenicity of Shingrix vaccination in patients suffering from Psoriasis or Psoriatic arthritis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Apr 2026
Brief summary (registry, in English)
To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 336 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 22 Nov 2023
- Lead sponsor
- Justus-Liebig-Universitaet Giessen
- Diseases
- Psoriasis
- EU CT number
- 2024-512881-32-00
- EudraCT number
- 2022-003477-36
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 336
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with psoriasis or psoriatic arthritis whose disease is under control. It studies the safety of the Shingrix shingles vaccine.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Psoriasis vulgaris and/or psoriatic arthritis with low disease activity: PASI ≤ 9 for skin disease and DAPSA ≤ 14 for joint disease, depending on the form.
- Earlier treatment
- No earlier Shingrix (recombinant zoster vaccine). No other shingles or chickenpox vaccine in the last 12 months. No disease flare with treatment escalation in the last 6 months.
Main reasons for not taking part
- Pregnant or breast feeding
- History of shingles (herpes zoster) or a chronic infectious disease
- Cancer not treated with the aim of removing all of the disease, or treated cancer with signs of disease within the last 5 years
- Allergy to Shingrix or any of its ingredients
- Another vaccine given too close to the Shingrix dose (30 days for live virus and mRNA vaccines, 8 days for inactivated or subunit vaccines)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Subject pregnant or breast feeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thermalsole und Schwefelbad Bentheim GmbH | Bad Bentheim | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| Infektio Research GmbH & Co. KG | Frankfurt Am Main | Germany | Recruiting |
| Goethe University Frankfurt | Frankfurt Am Main | Germany | Recruiting |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Recruiting |
| ICH Study Center Gmbh & Co. KG | Hamburg | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Rheumatologische Praxis Hannover GbR | Hanover | Germany | Recruiting |
| Philipps-Universitaet Marburg | Marburg | Germany | Recruiting |
| Hms GmbH | Merzig | Germany | Recruiting |
| Universitaet Muenster | Muenster | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR | Muenster | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR | Munich | Germany | Recruiting |
| Barmherzige Brueder gemeinnuetzige Traeger GmbH | Straubing | Germany | Recruiting |
| Studienteam Lahn-Dill-Siegerland GbR | Wetzlar | Germany | Recruiting |
| Klinikverbund St. Antonius und St. Josef GmbH | Wuppertal | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.