Safety and immunogenicity of SHIngrix VAccination in patients suffering from Psoriasis or Psoriatic arthritis (SHIVAP) - SHIVAP

Justus-Liebig University Giessen - KKS Marburg-Giessen0 个研究点目标入组 336 人开始时间: 2023年1月25日最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Justus-Liebig University Giessen - KKS Marburg-Giessen