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ACTIVE NOT RECRUITING
NCT03604406
PHASE2

The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept

Sponsor: Kevin Winthrop

View on ClinicalTrials.gov

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

BIOLOGICAL

Varicella Zoster Vaccine

live-attenuated vaccine to prevent herpes zoster

OTHER

Placebo Injection

Saline solution injection

BIOLOGICAL

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