EUCTR2022-003477-36-DERecruitingPhase 1
Safety and immunogenicity of SHIngrix VAccination in patients suffering from Psoriasis or Psoriatic arthritis (SHIVAP) - SHIVAP
Justus-Liebig University Giessen - KKS Marburg-Giessen0 sites336 target enrollmentStarted: January 25, 2023Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 336
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Diagnosis of psoriasis vulgaris and/or psoriatic arthritis;
- •2. 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;
- •3. Age = 18 and = 75 years;
- •4. Written informed consent;
- •5. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 224
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
Exclusion Criteria
- •1. Subject pregnant or breast feeding;
- •2. History of chronic infectious disease;
- •3. Past or current history of cancer not curatively treated. Curatively treated malignancies must be without evidence of disease for a minimum of 5 years upon enrollment;
- •4. Prior administration of recombinant zoster vaccine (RZV) at any point in time, or any other herpes zoster or varicella vaccine received less than 12 months ago.
- •5. Previous or current history of HZ;
- •6. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study;
- •7. Hypersensitivity to the active substance or to any of the other substance of Shingrix;
- •8. Live virus and mRNA vaccines cannot be administered within 30 days (before/after) RZV and inactivated/ subunit vaccines within 8 days (before/after) RZV;
- •9. 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;
- •10. Concurrent participation in another interventional AMG trial.
Investigators
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