Immune response to Shingrix in adults with psoriasis or myelofibrosis on immunomodulatory therapy
Official title: Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07534007 · Data updated 2026-11-12
This project will test how well the Shingrix vaccine triggers immune responses in adults with psoriasis or myelofibrosis who are or are not taking immunomodulating drugs.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | Ruxolitinib |
| Locations | 1 site (Pavia, Lombarda) |
| Status | Recruiting |
| Started | February 24, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07534007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with psoriasis or myelofibrosis, with or without immunomodulatory therapy, who have an expected life expectancy of at least 12 months and can give informed consent are eligible.
✕Probably not a fit
People under 18, those with conditions outside psoriasis or myelofibrosis, patients with a life expectancy under 12 months, or those who cannot provide consent are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study measures cellular and antibody responses to the recombinant adjuvanted glycoprotein E (gE) vaccine (RZV, Shingrix) in adults with psoriasis or myelofibrosis. Participants are grouped by whether they are receiving immunomodulatory therapies such as anti-TNF agents or JAK inhibitors, and blood samples are analyzed using ELISpot and serology assays. The protocol focuses on characterizing differences in cell-mediated immunity and antibody levels after vaccination. Findings aim to inform vaccination practices for patients receiving biologic or immunomodulatory treatments.
Why it matters
Potential benefit: If successful, results could help determine whether patients on immunomodulatory drugs mount adequate immune responses to Shingrix and guide timing or need for additional precautions.
How similar studies have gone: Previous studies have shown RZV elicits strong immune responses in older and some immunocompromised populations, but data are more limited for patients on specific biologic or JAK inhibitor therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients over 18 years of age; * All genders are eligible for the study; * Patients with psoriasis receiving immunomodulant therapy (anti-TNF); * Patients with psoriasis who do not require immunomodulant therapy; * Patients with myelofibrosis receiving immunomodulant therapy (anti-JAK, such as Ruxolitinib); * Patients with myelofibrosis not receiving immunomodulant treatment; * Life expectancy (as estimated by the treating physician) ≥ 12 months or more; * Signed informed consent. Exclusion Criteria: * • At the end of the observation period; * In case of death; * If informed consent is revoked.
Where it's running
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Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombarda, Italy Recruiting
Study contacts
- Study coordinator: Fausto Baldanti, Director
- Email: f.baldanti@smatteo.pv.it
- Phone: 0382502420
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the Shingrix vaccine in kidney transplant recipients
This study tests how well the Shingrix vaccine works and its safety for people waiting for a kidney transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.