VaccinePhase 4TACTICNCT07818356
Comparative Study of Two Vaccination Schedules for the Subunit Herpes Zoster Vaccine in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disease Patients Treated With Anti-CD20 Therapy: an Open-label Randomised Controlled Trial
A Phase 4 study testing Two-dose M0-M2 vaccination schedule and Two-dose M0-M6 vaccination schedule in people with Vaccine and Varicella-zoster Virus, run by University Hospital, Toulouse at 24 sites in France.
Trial summary
Immunocompromised individuals, such as patients with multiple sclerosis (MS) or diseases of the neuromyelitis optica spectrum (NMOSD) treated with an anti-CD20 monoclonal antibody, present an increased risk of shingles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine, Varicella-zoster Virus, Multiple Sclerosis
- What is being tested?
- Two-dose M0-M2 vaccination schedule and Two-dose M0-M6 vaccination schedule
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 24 sitesFrance
- Study dates
- 20 Oct 2026to 30 Nov 2030
- Phase
- Phase 4
- 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
Who may be able to join
- Patients with Multiple Sclerosis (any clinical form) or Neuromyelitis optica spectrum disease seropositive for aquaporin-4 antibodies (AQP4+)
- Aged 18 years or more
- Treated with anti-CD20 mAbs (Rituximab IV or Ocrelizumab IV or SC) since < 2 years with dosing intervals of 6 months (and for Rituximab, treated with 1g per infusion)
- Planned to receive the same anti-CD20 mAbs with dosing intervals of 6 months during the 13 months of the study (and for Rituximab, planned to receive 1g per infusion)
- Known history in the medical file of varicella, or VZV IgG serology known to evidence a prior infection
- Affiliated or beneficiary of a social security scheme
- Written and informed consent
- Understands and agrees to comply with the study procedures
Who cannot join
- Temporary contraindication to vaccination (concurrent episode of acute fever >38.5°C)
- Shingles in the last 12 months or VZV vaccination in the last 5 years
- Patients already treated or supposed to be treated with Ofatumumab (another anti-CD20 mAbs but delivered with a monthly subcutaneous injection)
- Patients who received high dose corticosteroids (methylprednisolone at a dose of ≥ 500 mg, administered over 1 to 5 days) in the 3 months prior to inclusion
- Patients who have been exposed to Cladribine in the prior 12 months
- Patients who received or were scheduled to receive any vaccination, except for influenza and SARS-CoV-2 vaccines during the epidemic season, within 2 weeks prior to the 2 RZV injections and up to 4 weeks after the second RZV injection
Show all 12Show fewer
- Hypersensitivity to the active substance or to one of the excipients
- Patient protected by the law (guardianship, curatorship)
- Pregnancy or breast-feeding
- Women of childbearing potential (WOCBP) without effective contraception throughout the duration of the trial
- Criteria related to the use of ancillary anti-CD20 treatments (Rituximab and Ocrelizumab):
- Hypersensitivity to the active substance or to any of the excipients Severe, active infections Severe immunodeficiency Severe heart failure or severe uncontrolled heart disease Known progressive malignancies
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
France24 sites
Jean Minjoz University Hospital
Besançon, 25 000
Eric Berger, MD, 03 81 66 80 98 ext. +33, eberger@chu-besancon.fr
Eric Berger, MD
Pellegrin Hospital Group
Bordeaux, 33 000
Aurélie Ruet, PHD, 05 56 79 55 21 ext. +33, aurelie.ruet@chu-bordeaux.fr
Aurélie Ruet, PHD
Côte de Nacre University Hospital
Caen, 14 033
Pierre Branger, MD, 02 31 06 46 17 ext. +33, branger-p@chu-caen.fr
Pierre Branger, MD
Gabriel Montpied Hospital
Clermont-Ferrand, 63 000
Pierre Clavelou, PHD, 04 73 75 22 01 ext. +33, pclavelou@chu-clermontferrand.fr
Pierre Clavelou, MD
GCS CHIC Henri Mondor
Créteil, 94 000
Alain Creange, PHD, 01 49 81 23 15 ext. +33, alain.creange@hmn.ap-hop-paris.fr
Alain Creange, PHD
Dijon Hospital University
Dijon, 21 000
Thibault Moreau, PHD, 03 80 29 37 53 ext. +33, thibault.moreau@chu-dijon.fr
Thibault Moreau, PHD
Nord Hospital - Grenoble University Hospital
Grenoble, 38 700
Olivier Casez, MD, 06 63 58 02 77 ext. +33, ocasez@chu-grenoble.fr
Olivier Casez, MD
Libourne Hospital Center
Libourne, 33 500
Arnaud Gagnol, MD, 05 57 55 70 05 ext. +33, arnaud.gagnol@ch-libourne.fr
Arnaud Gagnol, MD
Roger Salengro Hospital - Lille University Hospital
Lille, 59 037
Hélène Zephir, PHD, 03 20 44 57 65 ext. +33, helene.ZEPHIR@chu-lille.fr
Hélène Zephir, PHD
Catholics Institut Hospitals Group
Lille, 59 400
Arnaud Kwiatkowski, PHD, 03 20 87 49 01 ext. +33, Kwiatkowski.Arnaud@ghicl.net
Arnaud Kwiatkowski, PHD
Lyon Civil Hospices
Lyon, 69 002
Sandra Vukusic, PHD, 04 72 68 13 13 ext. +33, sandra.vukusic@chu-lyon.fr
Sandra Vukusic, PHD
Gui de Chauliac Hospital - Montpellier University Hospital
Montpellier, 34 295
Xavier Ayrignac, PHD, 04 67 33 95 18 ext. +33, x-ayrignac@chu-montpellier.fr
Xavier Ayrignac, PHD
Laennec Hospital
Nantes, 44 800
Sandrine Wiertlewski, MD, 02 40 16 52 85 ext. +33, sandrine.wiertlewski@chu-nantes.fr
Sandrine Wiertlewski, MD
Pasteur Hospital
Nice, 06 000
Mikael Cohen, PHD, 04 92 03 79 01 ext. +33, cohen.m@chu-nice.fr
Mikael Cohen, PHD
Nimes University Hospital
Nîmes, 30 900
Eric Thouvenot, PHD, 04 66 68 32 61 ext. +33, eric.thouvenot@chu-nimes.fr
Eric Thouvenot, PHD
15/20 Hospital
Paris, 75 012
Dalia Dimitri-Boulos, MD, 01 40 02 16 29 ext. +33, ddimitriboulos@15-20.fr
Dalia Dimitri-Boulos, MD
Pitié Salpetrière Hospital
Paris, 75 013
Céline Louapre, PHD, 01 42 16 57 66 ext. +33, celine.louapre@aphp.fr
Céline Louapre, PHD
Adolphe de Rothschild Hospital
Paris, 75 019
Marine Boudot de La Motte, MD, 01 48 03 68 52 ext. +33, mboudotdelamotte@for.paris.fr
Marine Boudot de La Motte, MD
Intercommunal Hospital Center of Poissy Saint-Germain
Poissy, 78 300
Olivier Heinzlef, MD, 01 39 27 41 92 ext. +33, olivier.heinzlef@ght-yvelinesnord.fr
Olivier Heinzlef, MD
La Miletrie University Hospital
Poitiers, 86 000
Amélie Dos Santos, MD, 05 49 44 44 44 ext. +33, Amelie.DOS-SANTOS@chu-poitiers.fr
Amélie Dos Santos, MD
Pontchaillou Hospital
Rennes, 35 000
Laure Michel, PHD, 02 99 28 42 66 ext. +33, Laure.MICHEL@chu-rennes.fr
Laure Michel, PHD
Charles Nicolle Hospital
Rouen, 76 000
Maxime Guillaume, MD, 02 32 88 89 90 ext. +33, Maxime.Guillaume@chu-rouen.fr
Maxime Guillaume, MD
Purpan Hospital
Toulouse, 31 300
Jonathan Ciron, MD, 05 61 77 91 06 ext. +33, ciron.j@chu-toulouse.fr
Jonathan Ciron, MD
Tours Hospital University
Tours, 37 000
Inès Doghri, MD, 02 47 47 80 23 ext. +33, I.DOGHRI@chu-tours.fr
Inès Doghri, MD
About this study
Immunocompromised individuals, such as patients with multiple sclerosis (MS) or diseases of the neuromyelitis optica spectrum (NMOSD) treated with an anti-CD20 monoclonal antibody, present an increased risk of shingles. The immunogenicity - and therefore the clinical effectiveness - of the recombinant vaccine against the varicella zoster virus based on glycoprotein E, recently recommended according to two-dose schedule two months apart in immunocompromised patients aged ≥ 18 years, could be significantly decreased when administered one month before and one month after the infusion of anti-CD20.
We hypothesize that, in patients with MS or NMOSD treated with anti-CD20 administered every six months, a two-dose M0-M6 vaccination schedule consisting of deferring the second dose six months after the first infusion, that is, five months after the anti-CD20 infusion, could improve vaccine immunogenicity and, consequently, the effectiveness of the vaccine.
Read the detailed description
Shingles, caused by reactivation of varicella zoster virus (VZV), is a common condition in immunocompromised people. Its prevention, which has long remained a medical need unmet among these patients, was improved thanks to the availability of the recombinant glycoprotein-based VZV vaccine E (gE). Based on demonstrated clinical efficacy and safety profile in the general population as well as in immunocompromised patients, this vaccine is recommended in France according to a two-person schedule doses spaced two months apart in immunocompromised patients aged ≥ 18 years. However, further studies are needed in order to optimize vaccination strategies according to the different types of immunosuppression.
Patients with MS or NMOSD, who are at increased risk of herpes zoster, are extensively treated with anti-CD20 monoclonal antibodies, which are known to significantly alter immune responses to vaccines, in particular when vaccination is carried out early after the infusion of anti-CD20.
We hypothesize that in patients with MS or NMOSD treated with anti-CD20 administered every six months, a two-dose M0-M6 vaccination schedule, consisting of deferring the second dose to six months after the first, that is, five months after the anti-CD20 infusion, could improve vaccine immunogenicity and, consequently, the effectiveness of the vaccine.
In this phase IV randomized, controlled, open-label, parallel-group trial, we will compare, within a homogeneous population of patients with MS or NMOSD receiving antiCD20, the humoral response induced by a two-dose vaccination schedule administered at 2 months (M0-M2, "2-month" or standard group) or 6 months (M0-M6, "6-month" or experimental group). After the screening and inclusion phase, patients randomized to the M0-M2 (standard) and M0-M6 (experimental) groups will receive a first dose of recombinant herpes zoster vaccine (RZV) one month before the next scheduled infusion of anti-CD20 monoclonal antibodies (M1). The second dose of RZV will be given at either 2 months ("2-month group", M2) or 6 months ("6-month group", M6). Patients will receive their usual anti-CD20 monoclonal antibody infusions at the appropriate time M1, M7 and M13. The primary outcome will be evaluated one month after the second vaccine dose (M3 for the "2 months" group and M7 for the "6 months" group). The kinetics, intensity, and persistence of humoral and cellular immune responses, as well as safety, will be analyzed as criteria for secondary judgments during the scheduled follow-up visits until M13.
- Conditions
- Vaccine, Varicella-zoster Virus, Multiple Sclerosis, Spectrum Disease Neuromyelitis Optica
- Being tested
- Two-dose M0-M2 vaccination schedule, Two-dose M0-M6 vaccination schedule
- Keywords
- herpes zoster, immunosuppression, anti-CD20 therapy, vaccination, immunogenicity, optimization
- Medical subject headings
- Chickenpox, Multiple Sclerosis, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-dose M0-M2 vaccination scheduleBiological
Patients randomized to the "2 months" vaccination group will receive their first dose of RZV vaccine one month before the next scheduled infusion anti-CD20 monoclonal antibody (M0 corresponding to the visit during the first dose of vaccine, M1 at the time of scheduled anti-CD20 infusion).
The second dose of RZV vaccine will be administered 2 months later. Patients will receive their regular anti-CD20 infusions at times M1, M7, and M13.
Two-dose M0-M6 vaccination scheduleBiological
Patients randomized to the "6 months" vaccination group will receive their first dose of RZV vaccine one month before the next scheduled infusion anti-CD20 monoclonal antibody (M0 corresponding to the visit during the first dose of vaccine, M1 at the time of scheduled anti-CD20 infusion).
The second dose of RZV vaccine will be administered 6 months later. Patients will receive their regular anti-CD20 infusions at times M1, M7, and M13.
| Study group | Role | What they receive |
|---|---|---|
| 2 months arm | Active comparator | Patients will receive the standard vaccination schedule in two doses in 2 months. Receives: Biological: Two-dose M0-M2 vaccination schedule |
| 6 months arm | Experimental | Patients will receive a vaccination schedule in two doses in 6 months. Receives: Biological: Two-dose M0-M6 vaccination schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral vaccine response rate for IgG anti-VZV gE response
It will be defined as the proportion of patients with at least a 4-fold increase in anti-VZV gE antibody titers (measured by ELISA) at 1 month after the 2nd vaccine dose compared to baseline (M0), or seroconversion for those who were seronegative at M0.
Measured: 3 months for the " 2 months " group and 7 months for the " 6 months " group
Secondary outcomes (5)
The humoral response in terms of Geometric Mean Titer (GMT) at 1 month after the 2nd vaccine dose.
It will be assessed by the ratio (M0-M6 versus M0-M2 groups) of the adjusted Geometric Mean Titer (GMT) of anti-VZV gE IgG at 1 month after the 2nd vaccine dose.
The adjusted GMT will correspond to the GMT at 1 month after the 2nd vaccine dose conditionally to the means of the log transformed GMT before vaccination at baseline (M0) calculated across the treatment groups.
Measured: 3 months for the " 2 months " group and 7 months for the " 6 months " group
Composite criteria of the humoral response up to M13
The kinetics, intensity and persistance will be assessed by the Geometric Mean Titer (GMT) of anti-VZV gE IgG measured at baseline (M0) and up to M13: before the 2nd vaccine dose, 1 month after the 2nd vaccine dose, and prior to the next anti CD20 infusions at M7 and M13.
Measured: 13 months
Composite criteria of the cellular response at 1 month after the 2nd vaccine dose
It will be assessed by the cellular vaccine response rate for gE-specific CD4[AIM+] T response measured 1 month after the 2nd vaccine dose.
The cellular VRR is defined as the proportion of patients with a proportion of gE-specific CD4[AIM+] T cells at least 2 times above the cutoff after vaccination.
The proportion of gE-specific CD4[AIM+] T cells among CD4 T cells is defined by the proportion of CD4 T cells expressing at least one Activation-Induced Marker (AIM), as detected by flow cytometry, following in vitro stimulation with a peptide pool covering the entire ectodomain of gE. The AIM include CD69, CD25, OX40, CD40L, and CD137. We will determine the cut-off of gE-specific CD4[AIM+] T cells by assessing cellular immune responses across a range of non-vaccinated, healthy individuals.
Measured: 3 months for the " 2 months " group and 7 months for the " 6 months " group
Composite criteria of the cellular response at M13
The kinetics, intensity and persistance of the cellular response up to M13 will be assessed by the proportion of gE-specific CD4[AIM+] T cells among CD4 T cells measured at baseline (M0) and up to M13 : before the 2nd vaccine dose, 1 month after the 2nd vaccine dose, and prior to the next anti-CD20 infusions at M7 and M13.
Measured: 13 months
The vaccine safety
The safety will be assessed by the adverse events including serious adverse events collected during the study.
Measured: from M0 to month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Jun 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccineStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Ciron, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818356
- Sponsor's protocol ID
- RC31/25/0535
- Other IDs
- PHRC 24-0185, 2025-525106-37-00, 2025
- Acronym
- TACTIC
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Sep 2026
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Vaccination Schedules for the Subunit Herpes Zoster Vaccine in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disease Patients Treated With Anti-CD20 Therapy: an Open-label Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07818356
- Acronym / sponsor ID
- TACTIC / RC31/25/0535
- Conditions
- Vaccine, Varicella-zoster Virus, Multiple Sclerosis, Spectrum Disease Neuromyelitis Optica
- Keywords
- herpes zoster, immunosuppression, anti-CD20 therapy, vaccination, immunogenicity, optimization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Jun 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 14 Sep 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.
Immunocompromised individuals, such as patients with multiple sclerosis (MS) or diseases of the neuromyelitis optica spectrum (NMOSD) treated with an anti-CD20 monoclonal antibody, present an increased risk of shingles. The immunogenicity - and therefore the clinical effectiveness - of the recombinant vaccine against the varicella zoster virus based on glycoprotein E, recently recommended according to two-dose schedule two months apart in immunocompromised patients aged ≥ 18 years, could be significantly decreased when administered one month before and one month after the infusion of anti-CD20.
We hypothesize that, in patients with MS or NMOSD treated with anti-CD20 administered every six months, a two-dose M0-M6 vaccination schedule consisting of deferring the second dose six months after the first infusion, that is, five months after the anti-CD20 infusion, could improve vaccine immunogenicity and, consequently, the effectiveness of the vaccine.
Detailed description
Shingles, caused by reactivation of varicella zoster virus (VZV), is a common condition in immunocompromised people. Its prevention, which has long remained a medical need unmet among these patients, was improved thanks to the availability of the recombinant glycoprotein-based VZV vaccine E (gE). Based on demonstrated clinical efficacy and safety profile in the general population as well as in immunocompromised patients, this vaccine is recommended in France according to a two-person schedule doses spaced two months apart in immunocompromised patients aged ≥ 18 years. However, further studies are needed in order to optimize vaccination strategies according to the different types of immunosuppression.
Patients with MS or NMOSD, who are at increased risk of herpes zoster, are extensively treated with anti-CD20 monoclonal antibodies, which are known to significantly alter immune responses to vaccines, in particular when vaccination is carried out early after the infusion of anti-CD20.
We hypothesize that in patients with MS or NMOSD treated with anti-CD20 administered every six months, a two-dose M0-M6 vaccination schedule, consisting of deferring the second dose to six months after the first, that is, five months after the anti-CD20 infusion, could improve vaccine immunogenicity and, consequently, the effectiveness of the vaccine.
In this phase IV randomized, controlled, open-label, parallel-group trial, we will compare, within a homogeneous population of patients with MS or NMOSD receiving antiCD20, the humoral response induced by a two-dose vaccination schedule administered at 2 months (M0-M2, "2-month" or standard group) or 6 months (M0-M6, "6-month" or experimental group). After the screening and inclusion phase, patients randomized to the M0-M2 (standard) and M0-M6 (experimental) groups will receive a first dose of recombinant herpes zoster vaccine (RZV) one month before the next scheduled infusion of anti-CD20 monoclonal antibodies (M1). The second dose of RZV will be given at either 2 months ("2-month group", M2) or 6 months ("6-month group", M6). Patients will receive their usual anti-CD20 monoclonal antibody infusions at the appropriate time M1, M7 and M13. The primary outcome will be evaluated one month after the second vaccine dose (M3 for the "2 months" group and M7 for the "6 months" group). The kinetics, intensity, and persistence of humoral and cellular immune responses, as well as safety, will be analyzed as criteria for secondary judgments during the scheduled follow-up visits until M13.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 months arm | Active comparator | Biological: Two-dose M0-M2 vaccination schedulePatients will receive the standard vaccination schedule in two doses in 2 months. |
| 6 months arm | Experimental | Biological: Two-dose M0-M6 vaccination schedulePatients will receive a vaccination schedule in two doses in 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with Multiple Sclerosis (any clinical form) or Neuromyelitis optica spectrum disease seropositive for aquaporin-4 antibodies (AQP4+)
- Aged 18 years or more
- Treated with anti-CD20 mAbs (Rituximab IV or Ocrelizumab IV or SC) since < 2 years with dosing intervals of 6 months (and for Rituximab, treated with 1g per infusion)
- Planned to receive the same anti-CD20 mAbs with dosing intervals of 6 months during the 13 months of the study (and for Rituximab, planned to receive 1g per infusion)
- Known history in the medical file of varicella, or VZV IgG serology known to evidence a prior infection
Key exclusion criteria (12 listed)
- Temporary contraindication to vaccination (concurrent episode of acute fever >38.5°C)
- Shingles in the last 12 months or VZV vaccination in the last 5 years
- Patients already treated or supposed to be treated with Ofatumumab (another anti-CD20 mAbs but delivered with a monthly subcutaneous injection)
- Patients who received high dose corticosteroids (methylprednisolone at a dose of ≥ 500 mg, administered over 1 to 5 days) in the 3 months prior to inclusion
- Patients who have been exposed to Cladribine in the prior 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-dose M0-M2 vaccination schedulePatients randomized to the "2 months" vaccination group will receive their first dose of RZV vaccine one month before the next scheduled infusion anti-CD20 monoclonal antibody (M0 corresponding to the visit during the first dose of vaccine, M1 at the time of scheduled anti-CD20 infusion). The second dose of RZV vaccine will be administered 2 months later. Patients will receive their regular anti-CD20 infusions at times M1, M7, and M13. | Biological | 2 months arm |
| Two-dose M0-M6 vaccination schedulePatients randomized to the "6 months" vaccination group will receive their first dose of RZV vaccine one month before the next scheduled infusion anti-CD20 monoclonal antibody (M0 corresponding to the visit during the first dose of vaccine, M1 at the time of scheduled anti-CD20 infusion). The second dose of RZV vaccine will be administered 6 months later. Patients will receive their regular anti-CD20 infusions at times M1, M7, and M13. | Biological | 6 months arm |
Primary outcome
Humoral vaccine response rate for IgG anti-VZV gE response
Time frame: 3 months for the " 2 months " group and 7 months for the " 6 months " group
It will be defined as the proportion of patients with at least a 4-fold increase in anti-VZV gE antibody titers (measured by ELISA) at 1 month after the 2nd vaccine dose compared to baseline (M0), or seroconversion for those who were seronegative at M0.
5 secondary outcomes
The humoral response in terms of Geometric Mean Titer (GMT) at 1 month after the 2nd vaccine dose.
Time frame: 3 months for the " 2 months " group and 7 months for the " 6 months " group
Composite criteria of the humoral response up to M13
Time frame: 13 months
Composite criteria of the cellular response at 1 month after the 2nd vaccine dose
Time frame: 3 months for the " 2 months " group and 7 months for the " 6 months " group
Composite criteria of the cellular response at M13
Time frame: 13 months
The vaccine safety
Time frame: from M0 to month 13
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 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Vaccine
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
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.
Jonathan Ciron, MD principal investigator
University Hospital, Toulouse
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Two-dose M0-M2 vaccination schedule and Two-dose M0-M6 vaccination schedule in people with Vaccine and Varicella-zoster Virus, run by University Hospital, Toulouse at 24 sites 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jonathan Ciron, MD (05 61 77 91 06 ext. +33, ciron.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral vaccine response rate for IgG anti-VZV gE response (time frame: 3 months for the " 2 months " group and 7 months for the " 6 months " group). 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 14 Sep 2026.