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Can delaying the second shingles shot boost protection for people on MS drugs?

NCT ID NCT07818356

Prevention Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

People with multiple sclerosis or neuromyelitis optica spectrum disorder who take anti-CD20 drugs have a higher risk of shingles. The shingles vaccine is recommended for them, but the drug may weaken its effect. This trial compares two dosing schedules: one gives the second shot two months after the first, and the other waits six months. Researchers will measure antibody levels to see which schedule produces a stronger immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
recombinant subunit herpes zoster vaccine (Shingrix)
What this could lead to
If the delayed schedule works better, it could change how doctors time shingles vaccination for people on anti-CD20 treatments, potentially offering stronger protection with the same vaccine.
What could go wrong
The trial may show no difference between the two schedules, or the delayed schedule might not improve protection enough to matter. People on anti-CD20 drugs may still respond poorly to the vaccine regardless of timing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

chickenpox multiple sclerosis neuromyelitis optica herpes zoster prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis Spectrum disease neuromyelitis optica Vaccine Varicella-zoster virus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 15/20 Hospital

    Paris, 75 012, France

  • Adolphe de Rothschild Hospital

    Paris, 75 019, France

  • Catholics Institut Hospitals Group

    Lille, 59 400, France

  • Charles Nicolle Hospital

    Rouen, 76 000, France

  • Côte de Nacre University Hospital

    Caen, 14 033, France

  • Dijon Hospital University

    Dijon, 21 000, France

  • GCS CHIC Henri Mondor

    Créteil, 94 000, France

  • Gabriel Montpied Hospital

    Clermont-Ferrand, 63 000, France

  • Gui de Chauliac Hospital - Montpellier University Hospital

    Montpellier, 34 295, France

  • Intercommunal Hospital Center of Poissy Saint-Germain

    Poissy, 78 300, France

  • Jean Minjoz University Hospital

    Besançon, 25 000, France

  • La Miletrie University Hospital

    Poitiers, 86 000, France

  • Laennec Hospital

    Nantes, 44 800, France

  • Libourne Hospital Center

    Libourne, 33 500, France

  • Lyon Civil Hospices

    Lyon, 69 002, France

  • Nimes University Hospital

    Nîmes, 30 900, France

  • Nord Hospital - Grenoble University Hospital

    Grenoble, 38 700, France

  • Pasteur Hospital

    Nice, 06 000, France

  • Pellegrin Hospital Group

    Bordeaux, 33 000, France

  • Pitié Salpetrière Hospital

    Paris, 75 013, France

  • Pontchaillou Hospital

    Rennes, 35 000, France

  • Purpan Hospital

    Toulouse, 31 300, France

  • Roger Salengro Hospital - Lille University Hospital

    Lille, 59 037, France

  • Tours Hospital University

    Tours, 37 000, France

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