The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept
Completed · Phase 2 · Has a placebo group
Conditions studied: Herpes Zoster, Inflammatory Disease, Rheumatoid Arthritis
In brief
This investigator-initiated study will serve as a sub-study for the American College of Rheumatology-sponsored VERVE protocol currently funded by the NIH. This double-blinded multicenter randomized pragmatic trial is designed to determine whether Zostavax or Shingrix are safe and effective in patients with rheumatoid arthritis (RA) currently using anti-tumor necrosis factor (TNF) therapies. Inclusion/exclusion criteria for this sub-study mirror that of the parent VERVE trial with the exception of abatacept therapy being allowed. Preliminary data from the VERVE parent protocol enrolling patients using anti-TNF therapy is encouraging in that few patients experienced adverse events (56 adverse events in 50 participants, out of 140 participants in total) and that 96.2% of these adverse events were considered either mild or moderate. Importantly, there have been no instances of vaccine dissemination or zoster events to date.
Key facts
- Study ID
- NCT03604406
- Run by
- Kevin Winthrop
- People needed
- 154
- Starts
- 2014-05-08
- Expected to finish
- 2026-01-12
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- St. Luke's Health System — Boise, Idaho, United States
- St. Paul Rheumatology — Eagan, Minnesota, United States
- Jayashree Sinha, MD — Clovis, New Mexico, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Arthritis Associates — Hixson, Tennessee, United States
Full record on ClinicalTrials.gov
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