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Two dosing schedules of the herpes zoster vaccine (recombinant varicella zoster virus glycoprotein E) in MS and NMOSD patients on rituximab or ocrelizumab

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Adults diagnosed with Multiple Sclerosis or Neuromyelitis optica spectrum disease and receiving an anti‑CD20 antibody called rituximab every six months are eligible for the trial, which evaluates the use of the subunit shingles vaccine Shingrix that protects against the virus that causes shingles.

The purpose of the study is to compare two different timing schedules for giving the vaccine in order to determine which schedule leads to a stronger antibody (immune‑system protein) response. In the standard schedule, the second vaccine dose is given two months after the first; in the experimental schedule, the second dose is given six months after the first.

Participants receive the first vaccine dose one month before their scheduled rituximab infusion, followed by the second dose either two months or six months later, depending on the assigned group. Blood samples are taken before the first dose, one month after the second dose, and at later visits to measure antibody levels and monitor any side effects. The study continues for about a year with regular clinic visits for safety checks.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial study visit

    You attend the first study visit after joining the trial. during this visit you sign the consent form, answer questionnaires about your health, and give a blood sample. this blood sample is called the baseline (m0) and will be used to compare future test results.

  2. Step 2

    First vaccine dose

    One month after the baseline visit you receive the first dose of shingrix, the herpes zoster vaccine. the injection contains 0.5 ml of the vaccine and is given under the skin. this dose is given before you receive your anti‑cd20 therapy.

  3. Step 3

    Anti‑cd20 therapy infusion

    Shortly after the first vaccine dose you receive an infusion of rituximab, a medication that reduces certain immune cells. the dose is 1 g (one gram) given intravenously. the infusion is scheduled every six months for the duration of the study.

  4. Step 4

    Second vaccine dose

    The timing of the second shingrix dose depends on the group you are assigned to:

    • if you are in the “2‑month group”, you receive the second 0.5 ml dose one month after the rituximab infusion.

    • if you are in the “6‑month group”, you receive the second 0.5 ml dose five months after the rituximab infusion.

  5. Step 5

    Post‑vaccination blood test

    One month after the second vaccine dose you attend a study visit for a blood test. this test measures the level of antibodies against the virus and determines whether the vaccine produced a sufficient response. the visit occurs at month 3 for the 2‑month group and at month 7 for the 6‑month group.

  6. Step 6

    Intermediate blood tests

    Additional blood samples are collected at several time points to monitor the immune response:

    • before the second vaccine dose,

    • before the next rituximab infusion at month 7,

    • and before the following rituximab infusion at month 13.

  7. Step 7

    Final study visit

    Around month 13 you attend the final study visit. during this visit you provide a last blood sample, answer any remaining questionnaires, and undergo a safety assessment to record any adverse events that may have occurred during the trial.

Who can join the trial?

8 criteria

  • Have a diagnosis of Multiple Sclerosis (any form) or Neuromyelitis optica spectrum disorder and a positive test for aquaporin‑4 antibodies (also called AQP4+), which are proteins in the blood that show the presence of this condition.
  • Be 18 years of age or older.
  • Be receiving an anti‑CD20 monoclonal antibody medication (either Rituximab given by IV infusion or Ocrelizumab given by IV infusion or subcutaneous injection) for less than 2 years, with each dose given every 6 months (Rituximab must be given at a dose of 1 gram per infusion).
  • Plan to continue the same anti‑CD20 medication on the same 6‑month schedule for the entire 13‑month study period (again, Rituximab at 1 gram per infusion).
  • Have a documented history of varicella (chickenpox) or a blood test called VZV IgG serology that shows a past infection with the virus.
  • Be enrolled in or receive benefits from a social security program.
  • Provide written, informed consent after understanding the study details.
  • Agree to follow all study procedures and understand what is required.

Who cannot join the trial?

14 criteria

  • Temporary contraindication to vaccination: you cannot join if you have a fever above 38.5°C (101.3°F) at the same time as the study.
  • Pregnancy or breast‑feeding: you are not allowed to take part if you are pregnant or feeding a baby.
  • Allergy to the study drug or its ingredients (called hypersensitivity to the active substance or any excipients, which are inactive ingredients).
  • Severe, active infections: you cannot participate if you have a serious infection that is currently active.
  • Severe immunodeficiency: you are excluded if your immune system is very weak.
  • Severe heart failure or uncontrolled heart disease: you cannot join if you have serious heart problems that are not well‑controlled.
  • Known progressive cancers (called malignancies).
  • Women of childbearing potential who are not using reliable birth control for the whole study period.
  • Shingles (a painful rash caused by the varicella‑zoster virus) in the last 12 months, or a varicella‑zoster vaccine (VZV vaccination) in the last 5 years.
  • Use of Ofatumumab: you cannot be in the study if you are already receiving or plan to receive this medication, which is another anti‑CD20 drug given by monthly injection.
  • High‑dose corticosteroids (specifically methylprednisolone 500 mg or more given over 1‑5 days) taken in the 3 months before joining.
  • Exposure to Cladribine (a medication for multiple sclerosis) in the past 12 months.
  • Other vaccinations (except the flu shot and COVID‑19 vaccine) given within 2 weeks before the first study vaccine dose or up to 4 weeks after the second dose.
  • Legal protection status: you cannot participate if you are under guardianship or curatorship (someone else makes legal decisions for you).
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Investigated drugs

  • Ocrelizumab

    is a medicine that works by targeting a protein called CD20 on certain immune cells (B‑cells). It is used to treat multiple sclerosis and neuromyelitis optica spectrum disease. In this study, patients who are already receiving ocrelizumab continue their regular treatment while the vaccine is being evaluated.

  • Rituximab

    is another drug that targets CD20 on B‑cells. It is given through an IV infusion and is also used for multiple sclerosis and neuromyelitis optica spectrum disease. Like ocrelizumab, patients who are on rituximab keep their usual dosing during the trial.

  • Shingrix

    is a recombinant (lab‑made) vaccine that protects against shingles (herpes zoster). It contains a piece of the virus that helps the body build immunity without causing disease. In this trial, the vaccine is given in two doses, and the researchers are comparing two different timing schedules to see which one creates a stronger immune response in patients who are on anti‑CD20 therapy.

What is already known about the treatment

  • Ocrelizumab

    This medication is given by injection and is approved for treating multiple sclerosis, especially the progressive forms. It works by attaching to a protein called CD20 on certain immune cells, which reduces those cells and helps slow disease activity. It belongs to the class of anti‑CD20 monoclonal antibodies and is widely studied in medical literature as a standard therapy for MS.

  • Rituximab

    Rituximab is administered as an intravenous infusion and is officially approved for some cancers and autoimmune conditions, and is often used off‑label for multiple sclerosis and neuromyelitis optica. The drug binds to the CD20 protein on B‑cells, leading to their removal and lowering harmful immune activity. It is classified as an anti‑CD20 monoclonal antibody and has a long history of research and clinical use.

  • Shingrix

    Shingrix is a suspension for injection supplied in a pre‑filled syringe and is used to prevent shingles (herpes zoster) in adults. It contains a recombinant piece of the varicella‑zoster virus protein together with an adjuvant that boosts the body’s immune response, helping the body recognize and fight the virus. This product is a recombinant subunit vaccine and is fully approved and widely recommended in medical guidelines.

Investigated diseases

  • Multiple sclerosis

    Multiple sclerosis is a chronic disorder of the central nervous system where the immune system mistakenly damages the protective coating of nerve fibers. This damage interferes with the transmission of electrical signals, causing episodes of weakness, numbness, visual disturbances, and coordination problems. Symptoms often appear in attacks that may improve partially, followed by periods of relative stability. Over time, new areas of damage can develop, leading to a gradual increase in disability. The disease course can vary, but many individuals experience a slow accumulation of neurological deficits.

  • Neuromyelitis optica spectrum disorder

    Neuromyelitis optica spectrum disorder is an inflammatory condition that primarily targets the optic nerves and spinal cord. It typically begins with sudden vision loss in one eye and can cause severe weakness or paralysis of the limbs. Recurrent attacks may lead to cumulative damage, resulting in lasting visual impairment and motor disability. The inflammation can spread to other parts of the central nervous system, producing additional neurological symptoms. As episodes repeat, the overall level of function may progressively decline.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525106-37-00Protocol codeRC31/25/0535Estimated enrolment160 patientsSponsorCentre Hospitalier Universitaire De Toulouse

sourced from the EU Clinical Trials Register and site verification

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