Comparative Study of Two Vaccination Schedules for the Subunit Herpes
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
What it found
No result yet.
What was tested
Treatment tested
- Two-dose M0-M6 vaccination schedule
- RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E
Compared with
- Two-dose M0-M2 vaccination schedule
What it measured
Main measures
Humoral vaccine response rate for IgG anti-VZV gE response
3 months for the " 2 months " group and 7 months for the " 6 months " group
Immune responseHumoral Vaccine Response Rate (VRR) measured 1 month after the 2nd vaccine dose (M3 for the “2 months” group and M7 for the “6 months” group), defined as the proportion of patients with at least a 4-fold increase in anti-VZV gE antibody titers (measured by ELISA) compared to baseline (M0), or seroconversion for those who were seronegative at M0.
Immune response
Other measures (12)
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
Immune responseComposite 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
Immune responseComposite criteria of the cellular response at M13
13 months
Immune responseThe vaccine safety
from M0 to month 13
SafetyRatio (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.
2. 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: M7 and M13.
Immune response3. Humoral VRR at M13
4. Cellular VRR for gE-specific CD4[AIM+] T response measured 1 month after the 2nd vaccine dose.
Immune responseProportion 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: M7 and M13.
Immune response
Who could take part
MS (type not specified) · 18 to 64
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Oct 2026
Main results due
Jun 2030
Finished
Nov 2030