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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Justus-Liebig-Universitaet Giessen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12]

Trial duration

22 Nov 2023 → ongoing

Decision date (initial)

2024-09-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GlaxoSmithKline Biologicals SA

External identifiers

EU CT number

2024-512881-32-00

EudraCT number

2022-003477-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Prophylaxis

To investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis.

Secondary objectives 4

1. To identify if Shingrix vaccination in patients suffering from Psoriasis or PSA results in a high and stable cellular and humoral immune response.
2. To determine the frequency of HZ and post-herpetic neuralgia.
3. To determine the frequency and severity of post-vaccination AEs/SAEs.
4. To determine the frequency of injection site reactions.

Conditions and MedDRA coding

Psoriasis vulgaris and/or psoriatric arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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.

Exclusion criteria 10

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 minimumof 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 than12 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 withcompletion 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 4

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. Frequency, duration and maximum severity of patients with HZ and post-herpetic neuralgia during treatment phase & follow-up. HZ will be laboratory (PCR) confirmed. Post herpetic neuralgia is defined as pain ≥90 days after confirmed HZ onset. Ad-hoc visits at time of primarily suspected HZ will be performed.
3. Frequency, duration and maximum severity of AEs/SAEs, together with measures of physical examination, vital signs, clinical chemistry, if deemed necessary, during treatment phase up to 60 days after second vaccination or after any doses.
4. Frequency, duration and maximum severity of injection site reactions (by physical examination 7 days post-vaccination and patient reporting)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Justus-Liebig-Universitaet Giessen

Sponsor organisation

Justus-Liebig-Universitaet Giessen

Address

Klinikstrasse 29

City

Giessen

Postcode

35392

Country

Germany

Scientific contact point

Organisation

Justus-Liebig-Universitaet Giessen

Contact name

Coordinating Investigator

Public contact point

Organisation

Justus-Liebig-Universitaet Giessen

Contact name

Project Management

Third parties 3

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications