Vaccination Varicella-zoster VirusZONAMIDNCT07047053
Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
An observational study of Vaccination Varicella-zoster Virus and Immune-mediated Systemic Inflammatory Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients with immune-mediated systemic inflammatory diseases (IMID) are at increased risk of shingles due to treatment-induced immunosuppression. In line with international recommendations, the French National Authority for Health (HAS) updated the varicella-zoster virus (VZV) vaccination strategy in March 2024. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccination Varicella-zoster Virus, Immune-mediated Systemic Inflammatory Diseases
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2025to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated for IMID in the internal medicine department of Hôpital Bichat, vaccinated against VZV as part of their care, in accordance with HAS recommendations.
Who may be able to join
- Patient over 18 years of age being managed for MIMI, including
- Systemic lupus
- Gougerot-Sjögren's syndrome
- Systemic scleroderma
- Mixed connectivitis
- Inflammatory myositis
Show all 19Show fewer
- Systemic sarcoidosis
- Systemic vasculitis (necrotizing vasculitis and giant cell arteritis)
- Behçet's disease
- Adult Still's disease
- IgG4-associated disease
- Autoimmune cytopenias (autoimmune hemolytic anemia, immunological thrombocytopenic purpura, Evans syndrome)
- Susac syndrome
- Followed in the internal medicine department of Hôpital Bichat, Paris
- Justifying VZV vaccination due to immunosuppression or age over 65.
- Vaccinated as part of care between June 2025 and June 2026
- Regardless of history of shingles
- With a serum sample available for analysis
- Having received at least the first dose of the vaccine regimen (in hospital or in the community)
Who cannot join
- Evolving cancer, with or without treatment (chemotherapy, immunotherapy, etc.)
- History of VZV vaccination (live or recombinant)
- Patient who has had an allergic reaction to a vaccine
- Pregnancy
- Patient under legal protection, guardianship or trusteeship
- Not affiliated to a social security scheme (general or CMU)
- Patient unable to understand research information
- Absence of non-opposition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Bichat
Paris, 75018
Tiphaine Goulenok, MD, 0140257289 ext. +33, tiphaine.goulenok@aphp.fr
About this study
Patients with immune-mediated systemic inflammatory diseases (IMID) are at increased risk of shingles due to treatment-induced immunosuppression. In line with international recommendations, the French National Authority for Health (HAS) updated the varicella-zoster virus (VZV) vaccination strategy in March 2024. The HAS now recommends that immunocompromised people aged 18 and over be vaccinated with the recombinant VZV vaccine. However, due to the immunosuppressive treatment received, the vaccine response in MIMI patients is often suboptimal, and the protection induced by the herpes zoster vaccine in this context is unknown.
The aim of our study is to determine the rate of anti-VZV seroconversion after vaccination with recombinant anti-VZV vaccine, in patients followed up for MIMI.
Read the detailed description
Vaccination with the recombinant anti-VZV vaccine (Shingrix) is carried out as part of treatment in all immunocompromised patients over 18 years of age, in accordance with HAS recommendations (the vaccination schedule requires 2 doses 2 months apart).
The vaccine response will be measured during hospitalisation and/or follow-up consultations, using the same sample as that used to monitor MIMI in the same laboratory (Immunology Laboratory, CHU Bichat).
Clinical and biological data will be collected to study factors associated with vaccine response, vaccine tolerance and MIMI activity.
Information relating to diagnosis, examinations and follow-up will be collated in the patient's medical file.
Patients are systematically seen every 6 months for follow-up consultations as part of their MIMI.
No additional visits are planned for research purposes.
- Keywords
- varicella-zoster virus, vaccination
- Medical subject headings
- Chickenpox
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 immune-mediated systemic inflammatory diseases (IMID) | All patients treated for IMID in the internal medicine department of Hôpital Bichat, vaccinated against VZV as part of their care, in accordance with HAS recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of antibodies specific to VZV gE glycoprotein and levels of specific T lymphocytes after stimulation with peptides contained in the vaccine (in SFC/106 PBMC)
Measured: at 3 and/or 6 month
level of antibodies specific to the VZV gE glycoprotein after stimulation with peptides contained in the vaccine (in SFC/106 PBMC)
Measured: at 3 and/or 6 month
Secondary outcomes (4)
Frequency of specific T cells
Measured: before vaccination, at 3 and/or 6 month
Tolerance of the VZV vaccine
occurrence of non-serious adverse events
Measured: at 3 and/or 6 month
Safety of the VZV vaccine
occurrence of serious adverse events
Measured: at 3 and/or 6 month
measuring change in IMID (Immune mediated inflammatory disease) activity. The data collected will be aggregated into a composite score.
The measures used depend on the scale specific to each IMID. The parameters collected will be the scales (SLEDAI for SLE, ESSDAI for Sjögren's syndrome, mRSS for systemic sclerosis, BSAS for Behcet's disease and BVAS for vasculitis), the physiological parameters collected by the referring doctor and, where appropriate, certain biological activity parameters (C-reactive protein, anti-DNA, ANCA, etc.). The data collected will be aggregated into a composite score.
Measured: at 3 and/or 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start10 Jun 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination Varicella-zoster VirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047053
- Sponsor's protocol ID
- APHP250443
- Other IDs
- 2025-A00547-42
- Acronym
- ZONAMID
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
- ClinicalTrials.gov ID
- NCT07047053
- Acronym / sponsor ID
- ZONAMID / APHP250443
- Keywords
- varicella-zoster virus, vaccination
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Jul 2025 (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.
Patients with immune-mediated systemic inflammatory diseases (IMID) are at increased risk of shingles due to treatment-induced immunosuppression. In line with international recommendations, the French National Authority for Health (HAS) updated the varicella-zoster virus (VZV) vaccination strategy in March 2024. The HAS now recommends that immunocompromised people aged 18 and over be vaccinated with the recombinant VZV vaccine. However, due to the immunosuppressive treatment received, the vaccine response in MIMI patients is often suboptimal, and the protection induced by the herpes zoster vaccine in this context is unknown.
The aim of our study is to determine the rate of anti-VZV seroconversion after vaccination with recombinant anti-VZV vaccine, in patients followed up for MIMI.
Detailed description
Vaccination with the recombinant anti-VZV vaccine (Shingrix) is carried out as part of treatment in all immunocompromised patients over 18 years of age, in accordance with HAS recommendations (the vaccination schedule requires 2 doses 2 months apart).
The vaccine response will be measured during hospitalisation and/or follow-up consultations, using the same sample as that used to monitor MIMI in the same laboratory (Immunology Laboratory, CHU Bichat).
Clinical and biological data will be collected to study factors associated with vaccine response, vaccine tolerance and MIMI activity.
Information relating to diagnosis, examinations and follow-up will be collated in the patient's medical file.
Patients are systematically seen every 6 months for follow-up consultations as part of their MIMI.
No additional visits are planned for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with immune-mediated systemic inflammatory diseases (IMID) | – | –All patients treated for IMID in the internal medicine department of Hôpital Bichat, vaccinated against VZV as part of their care, in accordance with HAS recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated for IMID in the internal medicine department of Hôpital Bichat, vaccinated against VZV as part of their care, in accordance with HAS recommendations.
Key inclusion criteria (19 listed)
- Patient over 18 years of age being managed for MIMI, including
- Systemic lupus
- Gougerot-Sjögren's syndrome
- Systemic scleroderma
- Mixed connectivitis
Key exclusion criteria (8 listed)
- Evolving cancer, with or without treatment (chemotherapy, immunotherapy, etc.)
- History of VZV vaccination (live or recombinant)
- Patient who has had an allergic reaction to a vaccine
- Pregnancy
- Patient under legal protection, guardianship or trusteeship
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
Levels of antibodies specific to VZV gE glycoprotein and levels of specific T lymphocytes after stimulation with peptides contained in the vaccine (in SFC/106 PBMC)
Time frame: at 3 and/or 6 month
level of antibodies specific to the VZV gE glycoprotein after stimulation with peptides contained in the vaccine (in SFC/106 PBMC)
Time frame: at 3 and/or 6 month
4 secondary outcomes
Frequency of specific T cells
Time frame: before vaccination, at 3 and/or 6 month
Tolerance of the VZV vaccine
Time frame: at 3 and/or 6 month
Safety of the VZV vaccine
Time frame: at 3 and/or 6 month
measuring change in IMID (Immune mediated inflammatory disease) activity. The data collected will be aggregated into a composite score.
Time frame: at 3 and/or 6 month
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 2 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Vaccination Varicella-zoster Virus
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia
Cardiovascular Disease, Dementia
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 Vaccination Varicella-zoster Virus and Immune-mediated Systemic Inflammatory Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 19 inclusion and 8 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 2 Jul 2025. 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 France. 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 Tiphaine Goulenok, MD (0140257289 ext. +33, tiphaine.goulenok@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of antibodies specific to VZV gE glycoprotein and levels of specific T lymphocytes after stimulation with peptides contained in the vaccine (in SFC/106 PBMC) (time frame: at 3 and/or 6 month). The study lists 2 primary outcomes in all. 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 2 Jul 2025.