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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-525106-37-00
Enrollment
160
Registered
2026-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis and Neuromyelitis optica spectrum

Brief summary

Humoral 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.

Detailed description

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., 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., 3. Humoral VRR at M13, 4. Cellular VRR for gE-specific CD4[AIM+] T response measured 1 month after the 2nd vaccine dose., 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: M7 and M13., Cellular VRR measured at M13., Adverse Events

Interventions

DRUGOCRELIZUMAB
DRUGRITUXIMAB
DRUGShingrix suspension for injection in pre-filled syringe Herpes zoster vaccine (recombinant
DRUGadjuvanted)

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Humoral 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.

Secondary

MeasureTime frame
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., 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., 3. Humoral VRR at M13, 4. Cellular VRR for gE-specific CD4[AIM+] T response measured 1 month after the 2nd vaccine dose., 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: M7 and M13., Cellular VRR measured at M13., Adverse Events

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 29, 2026