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
TACTIC
4 other identifiers
interventional
160
1 country
24
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2026
Longer than P75 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2026
CompletedFirst Posted
Study publicly available on registry
September 14, 2026
CompletedStudy Start
First participant enrolled
October 20, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2030
Study Completion
Last participant's last visit for all outcomes
November 30, 2030
September 14, 2026
September 1, 2026
3.7 years
September 7, 2026
September 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
3 months for the " 2 months " group and 7 months for the " 6 months " group
Composite criteria of the humoral response up to M13
13 months
Composite criteria of the cellular response at 1 month after the 2nd vaccine dose
3 months for the " 2 months " group and 7 months for the " 6 months " group
Composite criteria of the cellular response at M13
13 months
The vaccine safety
from M0 to month 13
Other Outcomes (6)
Composite criteria of the predicted humoral response at M20
20 months
The overall predicted humoral exposure from M0 to M20
20 months
The predicted cellular response at M20
20 months
- +3 more other outcomes
Study Arms (2)
2 months arm
ACTIVE COMPARATORPatients will receive the standard vaccination schedule in two doses in 2 months.
6 months arm
EXPERIMENTALPatients will receive a vaccination schedule in two doses in 6 months.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Jean Minjoz University Hospital
Besançon, 25 000, France
Pellegrin Hospital Group
Bordeaux, 33 000, France
Côte de Nacre University Hospital
Caen, 14 033, France
Gabriel Montpied Hospital
Clermont-Ferrand, 63 000, France
GCS CHIC Henri Mondor
Créteil, 94 000, France
Dijon Hospital University
Dijon, 21 000, France
Nord Hospital - Grenoble University Hospital
Grenoble, 38 700, France
Libourne Hospital Center
Libourne, 33 500, France
Roger Salengro Hospital - Lille University Hospital
Lille, 59 037, France
Catholics Institut Hospitals Group
Lille, 59 400, France
Lyon Civil Hospices
Lyon, 69 002, France
Gui de Chauliac Hospital - Montpellier University Hospital
Montpellier, 34 295, France
Laennec Hospital
Nantes, 44 800, France
Pasteur Hospital
Nice, 06 000, France
Nimes University Hospital
Nîmes, 30 900, France
15/20 Hospital
Paris, 75 012, France
Pitié Salpetrière Hospital
Paris, 75 013, France
Adolphe de Rothschild Hospital
Paris, 75 019, France
Intercommunal Hospital Center of Poissy Saint-Germain
Poissy, 78 300, France
La Miletrie University Hospital
Poitiers, 86 000, France
Pontchaillou Hospital
Rennes, 35 000, France
Charles Nicolle Hospital
Rouen, 76 000, France
Purpan Hospital
Toulouse, 31 300, France
Tours Hospital University
Tours, 37 000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Ciron, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2026
First Posted
September 14, 2026
Study Start (Estimated)
October 20, 2026
Primary Completion (Estimated)
June 20, 2030
Study Completion (Estimated)
November 30, 2030
Last Updated
September 14, 2026
Record last verified: 2026-09