Psoriasis vulgaris and/or psoriatric arthritis
Conditions
Brief summary
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.
Detailed description
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)
Interventions
Sponsors
Justus-Liebig-Universitaet Giessen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Outcome results
None listed