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

NCT07534007 | Recruiting DMC

• 1 other identifier: EVAZION
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

RZV Vaccine (Shingrix ®)

Keywords

ELISpot; immune response; serology

Outcome Measures

Primary Outcomes (1)

• Primary endpoint:

  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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• At the end of the observation period;
• In case of death;
• If informed consent is revoked.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombarda, 27100, Italy

RECRUITING

Central Study Contacts

Fausto Baldanti, Director

CONTACT

0382502420; f.baldanti@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-03

Locations

IT (1)