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Safety and immunologic response of SHIngrix VAccination in patients suffering from Psoriasis or Psoriatic arthritis
EU CTIS ID: 2024-512881-32-00
What this study is testing
To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Subject pregnant or breast feeding
- Concurrent participation in another interventional AMG trial
- 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
- 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
See the full eligibility criteria
- 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.
- Subject pregnant or breast feeding
- Concurrent participation in another interventional AMG trial
- 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
- 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
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.