Multiple Sclerosis and Neuromyelitis optica spectrum
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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 | — |