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

Phase 1

Conditions: Psoriasis vulgaris and/or psoriatric arthritis
MedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2022-003477-36-DE

Lead Sponsor: Justus-Liebig University Giessen - KKS Marburg-Giessen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 336

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.