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

April 10, 2026 updated by: Fausto Baldanti, Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All the subjects will be enrolled after signature of informed consent. Follow-up will be performed in case of confirmed arbovirus infection.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with psoriasis treated with biologics vaccined with Shigrix

Diagnostic Test: Immunological assays for characterization of T-cell mediated response ELISpot assay will be performed for monitoring of T-cell mediated response against the Varicella-Zoster antigens.

Diagnostic Test: Measurement of VZV- and gE-specific levels for monitoring humoral response

Diagnostic Test: Frequency of natural killer cells positive for the expression of 107a after co-culture with serum and infected cells for monitoring ADCC potential
Patients with Psoriasis untreated with biologics vaccined with Shigrix
Diagnostic Test: Immunological assays for characterization of T-cell mediated response ELISpot assay will be performed for monitoring of T-cell mediated response against the Varicella-Zoster antigens. Diagnostic Test: Measurement of VZV- and gE-specific levels for monitoring humoral response Diagnostic Test: Frequency of natural killer cells positive for the expression of 107a after co-culture with serum and infected cells for monitoring ADCC potential
Patients with myelofibrosis treated with biologics and vaccined with Shigrix
Diagnostic Test: Immunological assays for characterization of T-cell mediated response ELISpot assay will be performed for monitoring of T-cell mediated response against the Varicella-Zoster antigens. Diagnostic Test: Measurement of VZV- and gE-specific levels for monitoring humoral response Diagnostic Test: Frequency of natural killer cells positive for the expression of 107a after co-culture with serum and infected cells for monitoring ADCC potential
Patients with psoriasis untreated with biologics and vaccined with Shigrix
Diagnostic Test: Immunological assays for characterization of T-cell mediated response ELISpot assay will be performed for monitoring of T-cell mediated response against the Varicella-Zoster antigens. Diagnostic Test: Measurement of VZV- and gE-specific levels for monitoring humoral response Diagnostic Test: Frequency of natural killer cells positive for the expression of 107a after co-culture with serum and infected cells for monitoring ADCC potential

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint:
Time Frame: from enrolment to up 1 year
Comparison of cell-mediated immune response at 360 days (after complete vaccination schedule) in patients with Psoriasis or Myelofibrosis treated vs untreated.
from enrolment to up 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EVAZION

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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