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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; Shingrixâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
• Patients over 18 years of age;
Exclusion Criteria:
• At the end of the observation period;
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All the subjects will be enrolled after signature of informed consent. Follow-up will be performed in case of confirmed arbovirus infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fausto Baldanti, Director | Contact | 0382502420 | +39 | f.baldanti@smatteo.pv.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia | Recruiting | Pavia | Lombarda | 27100 | Italy |
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