Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03604406 | The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept | PHASE2 | COMPLETED | 154 | — | — | May 8, 2014 | Jan 12, 2026 | May 6, 2026 | 5 | United States |
Surrogate measures of vaccine efficacy will be performed on all patients using samples collected at baseline prior to vaccination, and subsequently at 6 weeks, and one year post vaccination. These measures will include: a. Frequency of VZV-specific T cells as measured by interferon-gamma ELISPOT assay. Changes in these outcome measures will be evaluated using geometric means and percentage increases in geometric means of (a) VZV-specific reactive lymphocytes.
Surrogate measures of vaccine efficacy will be performed on all patients using samples collected at baseline prior to vaccination, and subsequently at 6 weeks, and one year post vaccination. These measures will include: b. VZVgp-specific IgG titer as measured by ELISA Changes in these outcome measures will be evaluated using geometric means and percentage increases in geometric means of (b) VZV antibody titers in vaccine recipients as compared to placebo, as well as relative to baseline measures prior to vaccination.
| Arm | Type | Description |
|---|---|---|
| Varicella Zoster Vaccine (Zostavax) | EXPERIMENTAL | Live zoster vaccine injection will be administered as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Placebo Injection (Zostavax Comparator) | PLACEBO_COMPARATOR | Saline injection will be administered as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Varicella Zoster Vaccine (Shingrix) | EXPERIMENTAL | Non-live zoster vaccine injection will be administered twice, 8 weeks apart, as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Placebo Injection (Shingrix Comparator) | PLACEBO_COMPARATOR | Saline injection will be administered twice, 8 weeks apart, as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Name | Type | Description |
|---|---|---|
| Varicella Zoster Vaccine | BIOLOGICAL | live-attenuated vaccine to prevent herpes zoster |
| Placebo Injection | OTHER | Saline solution injection |
Inclusion criteria include: * be \>= 50 years of age or older (for the Zostavax® sub-study only) * be \>= 18 years of age or older (for the Shingrix® sub-study only) * be currently treated with abatacept therapy at the time of enrollment * Eligible women must be post-menopausal (\> 1 year since las...