RZV Vaccine (Shingrix ®)NCT07534007
Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies
An observational study of RZV Vaccine (Shingrix ®), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- RZV Vaccine (Shingrix ®)
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the subjects will be enrolled after signature of informed consent. Follow-up will be performed in case of confirmed arbovirus infection.
Who may be able to join
- • 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.
Who cannot join
- • At the end of the observation period;
- In case of death;
- If informed consent is revoked.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombarda, 27100
Fausto Baldanti, MD, segreteria.virologia@smatteo.pv.it
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint:
Comparison of cell-mediated immune response at 360 days (after complete vaccination schedule) in patients with Psoriasis or Myelofibrosis treated vs untreated.
Measured: from enrolment to up 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start24 Feb 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RZV Vaccine (Shingrix ®)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fausto Baldanti, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534007
- Sponsor's protocol ID
- EVAZION
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies
- ClinicalTrials.gov ID
- NCT07534007
- Acronym / sponsor ID
- EVAZION
- Conditions
- RZV Vaccine (Shingrix ®)
- Keywords
- ELISpot, immune response, serology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the subjects will be enrolled after signature of informed consent. Follow-up will be performed in case of confirmed arbovirus infection.
Key inclusion criteria (8 listed)
- • Patients over 18 years of age;
Key exclusion criteria (3 listed)
- • At the end of the observation period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Related trials for RZV Vaccine (Shingrix ®)
Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Rheumatoid Arthritis, Spondylitis, Ankylosing
Active, not recruitingPhase 4
Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls
RZV Vaccine (Shingrix ®)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RZV Vaccine (Shingrix ®), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fausto Baldanti, Director (0382502420 ext. +39, f.baldanti@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: (time frame: from enrolment to up 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.