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

10433

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.

2014-05-08

2025-06-01

2026-09-01

Active (not recruiting)

Early phase I

154

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 last menstrual period) or have a surgical history of bilateral oophorectomy or hysterectomy (for the Zostavax® sub-study only). * Female participants of childbearing potential may be enrolled in the study if the participant (for the Shingrix® sub-study only): * Has practiced adequate contraception for 30 days prior to vaccination; and * Has a negative urine pregnancy test on the day of the first vaccination; and * Has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series (Week 16) * Patients must have a history of prior chicken pox (for the Zostavax® sub-study only; for patients who do not recall prior chicken pox, a positive varicella IgG serology can be used to document prior exposure) Exclusion criteria include: * prior Zostavax® receipt (for the Zostavax® sub-study only; the Shingrix® sub-study will allow prior Zostavax® receipt if 6 months or greater prior to enrollment) * active contraindications to vaccination including allergy or sensitivity to gelatin or any other vaccine component * acute illness or infection * HIV/AIDS * current systemic corticosteroid use (including any oral or parenteral use in the previous 28 days) \[NOTE: this exclusion applies only for the Zostavax® portion of the study\] * methotrexate use \> 25 mg/week * dose of DMARDs not stable for \> 30 days * concomitant TNF antagonist use * receiving radiation or chemotherapy for cancer treatment * current leukemia * lymphoma, or other cancer affecting bone marrow or lymphatic system * cellular immunodeficiency * current use (within the last 30 days) of anti-viral medications against the herpesvirus family * Received any live virus vaccine within 28 days prior to study entry (Zostavax® sub-study only) * Administration or planned administration of any live vaccine \<28 days before the first study vaccination or through 28 days after the second study vaccination (Shingrix ® sub-study only) * received any inactivated vaccine within 7 days prior to study entry (Zostavax® sub-study only) * Received any inactivated vaccine +/- 14 days of each study injection (Shingrix ® sub-study only) * known household contacts who may be susceptible to a live virus vaccine (e.g. pregnant women) \[NOTE: this exclusion for the Zostavax® sub-study only\]

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2024-02-14