Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis, Inflammatory Arthritis, Arthritis, Psoriatic Arthritis, Psoriasis, Ankylosing Spondylitis, Enteropathic Arthritis, Crohn's Disease

In brief

The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the Herpes zoster (HZ) vaccine for shingles, Zostavax, in patients over 50 years old with arthritis and other diseases who are using anti-tumor necrosis factor (TNF) therapy and who have not previously received the vaccine.

Key facts

Study ID

NCT02538341

Run by

University of Alabama at Birmingham

People needed

617

Starts

2016-05-01

Expected to finish

2020-12-01

Last updated by the study team

2021-11-23

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be 50 years of age or older
• Must be currently treated with an anti-tumor necrosis factor (TNF) therapy** at the time of study drug administration, allowing for small deviations in dosing frequency and logistic feasibility (e.g. study visits to occur on a week day). Date of previous dose of medication is required. Specifically, meets one of the following: Etanercept dose within 9 days (1 week + 2 days), Adalimumab dose within 16 days (2 weeks + 2 days), Certolizumab Subcutaneous (SC) dose within 16 to 32 days depending on frequency schedule (2 weeks + 2 days, or 4 weeks and 4 days), Golimumab Subcutaneous (SC) dose within 32 days (4 weeks + 4 days), Golimumab Intravenous (IV) dose within 64 days (9 weeks + 1 day), Infliximab IV dose within last 64 days (9 weeks + 1 day)
• *any form of biosimilar for the above listed anti-tumor necrosis factor (TNF) medications is acceptable
• Diagnosis of rheumatoid arthritis or another inflammatory arthritis (Phase 1A); or other inflammatory condition (e.g. psoriasis) requiring use of anti-tumor necrosis factor (TNF) therapy (Phase 1B and II)
• Phase I subjects must test positive for varicella-zoster virus (VZV) antibody immunoglobulin G (IgG)
• Subjects should have a self-reported history of prior varicella infection (i.e. chicken pox) or long-term residence (>30 years) in the continental United States.
• Phase IA subjects must not have received any oral or systemic glucocorticoids within 30 days prior to vaccination. Intra-articular glucocorticoid injections and inhaled glucocorticoids within the previous 30 days are acceptable.
• Subjects should be on stable doses of all biologic and non-biologic Disease-modifying antirheumatic drugs (DMARDs) for a minimum of 30 days prior to vaccination.
• Eligible women must be post-menopausal (> 1 year since last menstrual period) or have a surgical history of bilateral oophorectomy or hysterectomy.
• Subjects should be ambulatory, community dwelling and capable of giving informed consent.

You may not qualify if…

• Documented varicella-zoster virus (VZV) antibody immunoglobulin G (IgG) negative result
• Prior use of the zoster vaccine (Zostavax®, Merck)
• Glucocorticoids at a prednisone-equivalent daily dose > 10mg/day (for Phase 1B and Phase II participants; all systemic glucocorticoid use is prohibited for Phase 1A patients)
• Any known contraindication to Zostavax® vaccine, including allergy or sensitivity to gelatin or any other vaccine component
• Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
• Currently receiving radiation or chemotherapy for any type of malignancy
• Any current use (within the last 30 days) of acyclovir, valacyclovir, famciclovir, or foscarnet
• Receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., diphtheria-tetanus (dT), pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 6 weeks after recruitment.
• Active infection or inter-current illness (e.g., urinary tract infection, influenza)
• Participated in an investigational study within 1 month prior to study entry
• Active drug or alcohol use, dependence, or any other reason that, in the opinion of the site investigator, would interfere with the study
• Significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years)
• Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g. uncontrolled comorbidity, life expectancy < 1 year)
• Patients who have household contact with varicella-susceptible pregnant women or severely immunosuppressed individuals without history of primary varicella.

Where it is running

• Rheumatology Associates, PC — Birmingham, Alabama, United States
• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States
• Clinical and Translational Research Center of Alabama, PC — Tuscaloosa, Alabama, United States
• SunValley Arthritis Center, Ltd — Peoria, Arizona, United States
• Arthritis Association of Southern California — Los Angeles, California, United States
• The Regents of the University of California Los Angeles — Los Angeles, California, United States
• Rheumatology Consultants of Delaware dba Delaware Arthritis — Lewes, Delaware, United States
• Center for Arthritis and Rheumatic Diseases — Miami, Florida, United States
• Coral Research Clinic Corp — Miami, Florida, United States
• Arthritis Research of Florida, Inc — Palm Harbor, Florida, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• West Broward Rheumatology Associates, Inc — Tamarac, Florida, United States
• North Georgia Rheumatology Group — Lawrenceville, Georgia, United States
• Arthritis Research Center Foundation, NDB — Wichita, Kansas, United States
• Ochsner Clinic Baton Rouge — Baton Rouge, Louisiana, United States
• Ochsner Clinic Foundation, New Orleans — New Orleans, Louisiana, United States
• Rheumatology & Osteoporosis Specialists — Shreveport, Louisiana, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Pine Hollow Partners — East Lansing, Michigan, United States
• St. Paul Rheumatology — Eagan, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• The Center for Rheumatology, LLP — Albany, New York, United States
• Mary Imogene Bassett Hospital, Bassett Research Institute — Cooperstown, New York, United States

Full record on ClinicalTrials.gov

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