Safety and immunogenicity of Shingrix vaccination in patients suffering from Psoriasis or Psoriatic arthritis
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Justus-Liebig-Universitaet Giessen
- Enrollment
- 336
- Locations
- 15
- Primary Endpoint
- Increase of Psoriasis arthritis and/or Psoriasis vulgaris activity under Shingrix vaccination defined as increase in DAPSA (by ≥ 15 points) or PASI (by ≥ 10 points) scores within 12 weeks after the first vaccination. If PsA activity arises in patients who only had Pso at inclusion or Pso activity arises in patients who only had PsA at inclusion, the trial steering committee will adjudicate whether this should be regarded as an increase in activity with respect to the primary endpoint.
Overview
Brief Summary
To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion 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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Increase of Psoriasis arthritis and/or Psoriasis vulgaris activity under Shingrix vaccination defined as increase in DAPSA (by ≥ 15 points) or PASI (by ≥ 10 points) scores within 12 weeks after the first vaccination. If PsA activity arises in patients who only had Pso at inclusion or Pso activity arises in patients who only had PsA at inclusion, the trial steering committee will adjudicate whether this should be regarded as an increase in activity with respect to the primary endpoint.
Increase of Psoriasis arthritis and/or Psoriasis vulgaris activity under Shingrix vaccination defined as increase in DAPSA (by ≥ 15 points) or PASI (by ≥ 10 points) scores within 12 weeks after the first vaccination. If PsA activity arises in patients who only had Pso at inclusion or Pso activity arises in patients who only had PsA at inclusion, the trial steering committee will adjudicate whether this should be regarded as an increase in activity with respect to the primary endpoint.
Secondary Outcomes
- Number of patients with humoral and cell-mediated vaccine response against the recombinant zoster vaccine (RZV) defined as increase in titer (anti VZV-ELISA) and/or glycoprotein E positive CD4-T-Cells) at 8 and at 52 weeks post first vaccination
- Rate of patients with HZ and post-herpetic neuralgia during treatment phase & follow-up. HZ will be laboratory (PCR) confirmed. Ad-hoc visits at time of primarily suspected HZ will be performed.
- AEs/SAEs, physical examination, vital signs, clinical chemistry during treatment phase up to 60 days after second vaccination or after any doses
- Frequency of injection site reactions (by physical examination 7 days post-vaccination and patient reporting)
Investigators
Annika Schneider
Scientific
Justus-Liebig-Universitaet Giessen