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The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept
Sponsor: Kevin Winthrop
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2014-05-08
Completion Date
2026-02
Last Updated
2025-09-10
Healthy Volunteers
No
Interventions
Varicella Zoster Vaccine
live-attenuated vaccine to prevent herpes zoster
Placebo Injection
Saline solution injection
Varicella Zoster Vaccine
non-live vaccine to prevent herpes zoster
Locations (5)
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