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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003477-36-DE

Enrollment

336

Registered

2023-01-25

Start date

2023-06-27

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis vulgaris and/or psoriatric arthritis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Shingrix Pharmaceutical Form: Powder and suspension for suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.;Secondary Objective: To identify if Shingrix vaccination in patients suffering from Psoriasis or PSA results in a high and stable cellular and humoral immune response. To determine the frequency of HZ and post-herpetic neuralgia. To determine the frequency and severity of post-vaccination AEs/SAEs. To determine the frequency of injection site reactions. ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 12 weeks after the first vaccination	—

Measure

Time frame

Main Objective: To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.;Secondary Objective: To identify if Shingrix vaccination in patients suffering from Psoriasis or PSA results in a high and stable cellular and humoral immune response. To determine the frequency of HZ and post-herpetic neuralgia. To determine the frequency and severity of post-vaccination AEs/SAEs. To determine the frequency of injection site reactions. ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 12 weeks after the first vaccination

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Secondary

Measure	Time frame
Secondary end point(s): 1. 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; 2. Rate of patients with HZ and post-herpetic neuralgia during treatment phase & follow-up. HZ will be laboratory (PCR) confirmed; 3. Ad-hoc visits at time of primarily suspected HZ will be performed; 4. AEs/SAEs, physical examination, vital signs, clinical chemistry during treatment phase up to 60 days after second vaccination or after any doses; 5. Frequency of injection site reactions (by physical examination 7 days post-vaccination and patient reporting).;Timepoint(s) of evaluation of this end point: ad 1: at 8 and at 52 weeks post first vaccination ad 2: ongoing until end of study ad 3: ongoing until end of study ad 4: up to 60 days after second vaccination or after any doses ad 5: 7 days post-vaccination	—

Measure

Time frame

Secondary end point(s): 1. 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; 2. Rate of patients with HZ and post-herpetic neuralgia during treatment phase & follow-up. HZ will be laboratory (PCR) confirmed; 3. Ad-hoc visits at time of primarily suspected HZ will be performed; 4. AEs/SAEs, physical examination, vital signs, clinical chemistry during treatment phase up to 60 days after second vaccination or after any doses; 5. Frequency of injection site reactions (by physical examination 7 days post-vaccination and patient reporting).;Timepoint(s) of evaluation of this end point: ad 1: at 8 and at 52 weeks post first vaccination ad 2: ongoing until end of study ad 3: ongoing until end of study ad 4: up to 60 days after second vaccination or after any doses ad 5: 7 days post-vaccination

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Countries

Germany

Contacts

Public ContactAnnika Schneider

Coordination Centre for Clinical Trials Marburg-Giessen

shivap@kks.uni-marburg.de+496421 2866458

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026