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Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies

Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07534007
Enrollment
150
Registered
2026-04-16
Start date
2026-02-24
Completion date
2027-12-01
Last updated
2026-04-16

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

Conditions

RZV Vaccine (Shingrix ®)

Keywords

ELISpot, immune response, serology

Brief summary

Varicella-zoster virus (VZV) is one of the eight herpesviruses that infect humans by manifesting as varicella. After primary infection VZV remains latent for life. In 30% of individuals the virus reactivates causing a secondary infection, herpes zoster (HZ). The most common complication of HZ is post-herpetic neuralgia (PHN) and, in severe cases, disseminated infection and death. The incidence of HZ increases as cell-mediated immunity (CMI) declines due to advanced age or the administration of immunomodulatory or immunosuppressive therapies. With the approval of the recombinant adjuvanted glycoprotein E (gE) vaccine (RZV; Shingrix™, GSK) also in immunocompromised individuals (IC) HZ is now considered a vaccine preventable disease. The development of novel biologic therapies has revolutionized the treatment of inflammatory skin conditions improving clinical responses in psoriasis and psoriatic arthritis patients. Although the overall safety records of biologic therapies are outstanding, there is evidence of an increased risk of contracting viral infections by nature of their inherent immunomodulatory and immunosuppressive effects. Primary myelofibrosis (MF) is a myeloproliferative neoplasm. The development and approval of ruxolitinib, the first JAK1/2 inhibitor indicated to treat MF, has improved patient outcomes and overall survival. However, JAK inhibitors also suppressed the immune system impairing Natural Killer cell function and virus-specific T cell response. These may potentially result in increased infections (and in particular of VZV reactivation). Given the increased risk of HZ associated with immunomodulant therapy, data on the immunogenicity and safety of RZV in IC populations are urgently needed.

Interventions

None listed

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary endpoint:from enrolment to up 1 yearComparison of cell-mediated immune response at 360 days (after complete vaccination schedule) in patients with Psoriasis or Myelofibrosis treated vs untreated.

Countries

Italy

Contacts

CONTACTFausto Baldanti, Director
f.baldanti@smatteo.pv.it0382502420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026