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Study on the Safety and Immune Response of Shingrix Vaccine in Patients with Psoriasis or Psoriatic Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and immune response of the vaccine Shingrix in patients who have Psoriasis or Psoriatic Arthritis. Psoriasis is a skin condition that causes red, itchy, and scaly patches, while Psoriatic Arthritis is a type of arthritis that affects some people with Psoriasis. The vaccine being tested, Shingrix, is designed to protect against shingles, a painful rash caused by the reactivation of the chickenpox virus. The vaccine contains a component called recombinant varicella zoster virus glycoprotein E, which helps the body build immunity against the virus.

The purpose of this study is to investigate how safe the Shingrix vaccine is for people with these conditions and how it affects their disease activity. Participants in the study will receive the vaccine and be monitored over a period of time to see if there are any changes in their Psoriasis or Psoriatic Arthritis symptoms. The study will also look at how well the immune system responds to the vaccine by measuring certain immune markers in the blood.

Throughout the study, participants will receive two doses of the Shingrix vaccine, given as an injection into the muscle. They will be observed for any side effects, such as reactions at the injection site or other health changes. The study will last for about a year, with regular check-ups to ensure the safety and effectiveness of the vaccine. Participants will also be checked for any signs of shingles or related complications during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination
Receive the first dose of the Shingrix vaccine. This vaccine is administered as a suspension for injection and is given through intramuscular use.
The vaccine is designed to protect against herpes zoster, commonly known as shingles.
Step 2
Monitoring period after first vaccination
For 12 weeks following the first vaccination, monitor for any increase in psoriasis or psoriatic arthritis activity. This is measured by specific scores: PASI (Psoriasis Area and Severity Index) and DAPSA (Disease Activity in Psoriatic Arthritis).
Report any new symptoms or changes in condition to the trial team.
Step 3
Second vaccination
Receive the second dose of the Shingrix vaccine. This is part of the standard vaccination schedule to ensure optimal protection.
The second dose is typically administered several weeks after the first dose, as per the trial schedule.
Step 4
Monitoring period after second vaccination
Continue to monitor for any changes in disease activity for up to 60 days after the second vaccination.
Report any adverse events or side effects, such as injection site reactions, to the trial team.
Step 5
Long-term follow-up
Participate in follow-up assessments at 8 weeks and 52 weeks after the first vaccination to evaluate the immune response to the vaccine.
These assessments will include measuring the body's response to the vaccine through blood tests and other evaluations.

Who can join the trial?

9 criteria

The patient must have a diagnosis of psoriasis vulgaris and/or psoriatic arthritis. Psoriasis vulgaris is a skin condition that causes red, scaly patches, and psoriatic arthritis is a type of arthritis that affects some people with psoriasis.
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The patient must meet certain score thresholds depending on their condition:
- For patients with both psoriasis and psoriatic arthritis, the PASI score should be 9 or less, and the DAPSA score should be 14 or less. PASI (Psoriasis Area and Severity Index) measures the severity of psoriasis, and DAPSA (Disease Activity in Psoriatic Arthritis) measures the activity of psoriatic arthritis.
- For patients with only psoriasis vulgaris, the PASI score should be 9 or less.
- For patients with psoriatic arthritis without major skin involvement, the DAPSA score should be 14 or less.
- The patient must be between 18 and 75 years old.
- The patient must provide written informed consent, which means they agree to participate in the study after being informed about it.
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  Women who can have children should use at least one of the following birth control methods until 2 months after the second vaccination (week 24 of the study):
  - Progestogen-only oral hormonal contraception, where stopping ovulation is not the main way it works.
  - Male or female condom, with or without spermicide.
  - Cap, diaphragm, or sponge with spermicide.

Who cannot join the trial?

3 criteria

Patients who do not have **psoriasis vulgaris** or **psoriatic arthritis**. Psoriasis vulgaris is a skin condition that causes red, scaly patches, and psoriatic arthritis is a type of arthritis that affects some people with psoriasis.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups of people who might need special protection or care.

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Verified sites

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Goethe University Frankfurt
Frankfurt, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany
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Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany

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Investigated drugs

Shingrix is a vaccine used to prevent shingles, a painful rash caused by the reactivation of the chickenpox virus. In this clinical trial, Shingrix is being tested for its safety and ability to trigger an immune response in patients who have psoriasis or psoriatic arthritis. The goal is to ensure that the vaccine does not worsen the symptoms of these conditions while still providing protection against shingles.

Recombinant Varicella Zoster Virus Glycoprotein E

What is already known about the treatment

Shingrix – Shingrix is a vaccine administered via intramuscular injection, typically in the upper arm. It is currently well-established in medical literature as a vaccine for preventing shingles, particularly in older adults. The main therapeutic indication for Shingrix is to prevent shingles and its complications, such as postherpetic neuralgia. At the molecular level, Shingrix works by stimulating the immune system to produce a strong and long-lasting immune response against the varicella-zoster virus, which causes shingles. It is classified pharmacologically as a vaccine.

Investigated diseases

Psoriasis Vulgaris
Psoriasis vulgaris is a chronic skin condition characterized by red, scaly patches that can appear on various parts of the body. These patches are caused by an accelerated growth cycle of skin cells, leading to a buildup of cells on the skin's surface. The condition can vary in severity, with some individuals experiencing only minor patches and others having widespread areas of thick, inflamed skin. Psoriasis vulgaris can also cause itching and discomfort, and the appearance of the skin can affect a person's quality of life. The condition often goes through cycles, with periods of flare-ups followed by times of remission. Environmental factors, stress, and certain medications can trigger or worsen the symptoms.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory arthritis associated with psoriasis, a skin condition. It primarily affects the joints and areas where tendons and ligaments connect to bone, causing pain, stiffness, and swelling. The progression of psoriatic arthritis can vary, with some individuals experiencing mild symptoms and others having more severe joint damage. The disease can affect any joint in the body, and symptoms may come and go, with periods of increased activity followed by remission. In addition to joint issues, psoriatic arthritis can also cause fatigue and affect the nails, leading to pitting or separation from the nail bed. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.