Immune response to Shingrix in adults with psoriasis or myelofibrosis on immunomodulatory therapy
Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | Ruxolitinib |
| Locations | 1 site (Pavia, Lombarda) |
| Trial ID | NCT07534007 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pavia, Lombarda
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.